Data / Medical devices / United States / Compass Health Brands (corporate Office)

Compass Health Brands (corporate Office): FDA-registered device maker in Middleburg Heights, OH, United States, 97 510(k) clearances

Name: Compass Health Brands (corporate Office) FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Compass Health Brands (corporate Office) is registered with the FDA (registration 3012316249) in Middleburg Heights, OH, United States. It lists 119 device types. The FDA files 97 510(k) clearances under its listings, the newest dated August 21, 2025. 4 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012316249
Address: 6753 Engle Rd, Middleburg Heights, OH, United States, 44130
Owner or operator: Compass Health Brands (Corporate Office) (2182780)
Roles: Complaint file establishment, Specification developer
First device listed: June 30, 1992
Registered through: 2026
Brand names listed: Adaptive Cutlery, Aid(s) for Daily Living, Apex, Apex Pill Organizers, Aspirator, High Vacuum/Low Flow, COMPASS HEALTH BRANDS, Carex, Carex Health Brands and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Traction	ILZ	1	Complaint file establishment	accessdata.fda.gov
Accessories, Wheelchair	KNO	1	Complaint file establishment	accessdata.fda.gov
Adaptor, Dressing	ILD	1	Complaint file establishment	accessdata.fda.gov
Adaptor, Holder, Syringe	IQG	1	Complaint file establishment	accessdata.fda.gov
Adaptor, Hygiene	ILS	1	Complaint file establishment	accessdata.fda.gov
Adaptor, Recreational	ILT	1	Complaint file establishment	accessdata.fda.gov
Adult Portable Bed Rails For Medical Purposes	QTC	1	Complaint file establishment	accessdata.fda.gov
Aid, Transfer	IKX	1	Complaint file establishment	accessdata.fda.gov
Apparatus, Suction, Single Patient Use, Portable, Nonpowered	GCY	1	Complaint file establishment	accessdata.fda.gov
Apparatus, Suction, Ward Use, Portable, Ac-Powered	JCX	2	Complaint file establishment	accessdata.fda.gov
Apparatus, Traction, Non-Powered	HST	1	Complaint file establishment	accessdata.fda.gov
Attachment, Commode, Wheelchair	INB	1	Complaint file establishment	accessdata.fda.gov
Bariatric Bed	OSI	2	Complaint file establishment	accessdata.fda.gov
Bath, Sitz, Nonpowered	KTC	1	Complaint file establishment	accessdata.fda.gov
Bed, Ac-Powered Adjustable Hospital	FNL	2	Complaint file establishment	accessdata.fda.gov
Bed, Manual	FNJ	1	Complaint file establishment	accessdata.fda.gov
Bedpan	FOB	1	Complaint file establishment	accessdata.fda.gov
Bottle, Collection, Vacuum	KDQ	2	Complaint file establishment	accessdata.fda.gov
Bottle, Hot/Cold Water	FPF	1	Complaint file establishment	accessdata.fda.gov
Cable, Electrode	IKD	2	Complaint file establishment	accessdata.fda.gov
Cane	IPS	1	Complaint file establishment	accessdata.fda.gov
Cane, Safety Walk	KHY	1	Complaint file establishment	accessdata.fda.gov
Cannula, Nasal, Oxygen	CAT	1	Complaint file establishment	accessdata.fda.gov
Cart, Emergency, Cardiopulmonary (Excluding Equipment)	BZN	1	Complaint file establishment	accessdata.fda.gov
Case, Contact Lens	LRX	2	Complaint file establishment	accessdata.fda.gov
Chair And Table, Medical	KMN	1	Complaint file establishment	accessdata.fda.gov
Chair, Adjustable, Mechanical	INN	1	Complaint file establishment	accessdata.fda.gov
Chair, With Casters	INM	1	Complaint file establishment	accessdata.fda.gov
Clip, Nose	BXJ	1	Complaint file establishment	accessdata.fda.gov
Components, Wheelchair	KNN	1	Complaint file establishment	accessdata.fda.gov
Compressor, Air, Portable	BTI	2	Complaint file establishment	accessdata.fda.gov
Connector, Airway (Extension)	BZA	1	Complaint file establishment	accessdata.fda.gov
Conserver, Oxygen	NFB	2	Complaint file establishment	accessdata.fda.gov
Container, Liquid Medication, Graduated	KYW	1	Complaint file establishment	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Complaint file establishment	accessdata.fda.gov
Cover, Cast	KIA	1	Complaint file establishment	accessdata.fda.gov
Cover, Mattress (Medical Purposes)	FMW	1	Complaint file establishment	accessdata.fda.gov
Crutch	IPR	1	Complaint file establishment	accessdata.fda.gov
Cushion, Flotation	KIC	1	Complaint file establishment	accessdata.fda.gov
Cushion, Hemorrhoid	LRL	U	Complaint file establishment	accessdata.fda.gov
Cushion, Wheelchair	IMP	1	Complaint file establishment	accessdata.fda.gov
Device, Biofeedback	HCC	2	Complaint file establishment	accessdata.fda.gov
Device, Fertility Diagnostic, Proceptive	LHD	U	Complaint file establishment	accessdata.fda.gov
Device, Fixation, Tracheal Tube	CBH	1	Complaint file establishment	accessdata.fda.gov
Device, Iontophoresis, Other Uses	EGJ	2	Complaint file establishment	accessdata.fda.gov
Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat	IMJ	2	Complaint file establishment	accessdata.fda.gov
Dispenser, Liquid Medication	KYX	1	Complaint file establishment	accessdata.fda.gov
Dispenser, Solid Medication	NXB	1	Complaint file establishment	accessdata.fda.gov
Drain, Tee (Water Trap)	BYH	1	Complaint file establishment	accessdata.fda.gov
Dropper, Ent	KCM	1	Complaint file establishment	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Complaint file establishment	accessdata.fda.gov
Exerciser, Non-Measuring	ION	1	Complaint file establishment	accessdata.fda.gov
Exerciser, Powered	BXB	1	Complaint file establishment	accessdata.fda.gov
Filter, Bacterial, Breathing-Circuit	CAH	2	Complaint file establishment	accessdata.fda.gov
Footrest, Wheelchair	IMM	1	Complaint file establishment	accessdata.fda.gov
Generator, Oxygen, Portable	CAW	2	Complaint file establishment	accessdata.fda.gov
Humidifier, Respiratory Gas, (Direct Patient Interface)	BTT	2	Complaint file establishment	accessdata.fda.gov
Interferential Current Therapy	LIH	2	Complaint file establishment	accessdata.fda.gov
Joint, Ankle, External Brace	ITW	1	Complaint file establishment	accessdata.fda.gov
Joint, Hip, External Brace	ITS	1	Complaint file establishment	accessdata.fda.gov
Joint, Knee, External Brace	ITQ	1	Complaint file establishment	accessdata.fda.gov
Lamp, Infrared, Therapeutic Heating	ILY	2	Complaint file establishment	accessdata.fda.gov
Lift, Patient, Non-Ac-Powered	FSA	1	Complaint file establishment	accessdata.fda.gov
Mask, Oxygen	BYG	1	Complaint file establishment	accessdata.fda.gov
Massager, Powered Inflatable Tube	IRP	2	Complaint file establishment	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Complaint file establishment	accessdata.fda.gov
Mattress And Bed Deck Cover (Medical Purposes)	QTV	1	Complaint file establishment	accessdata.fda.gov
Mattress, Air Flotation, Alternating Pressure	FNM	2	Complaint file establishment	accessdata.fda.gov
Mattress, Flotation Therapy, Non-Powered	IKY	1	Complaint file establishment	accessdata.fda.gov
Media, Coupling, Ultrasound	MUI	2	Complaint file establishment	accessdata.fda.gov
Media, Electroconductive	GYB	2	Complaint file establishment	accessdata.fda.gov
Monitor, Bed Patient	KMI	1	Complaint file establishment	accessdata.fda.gov
Nebulizer (Direct Patient Interface)	CAF	2	Complaint file establishment	accessdata.fda.gov
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	CCQ	1	Complaint file establishment	accessdata.fda.gov
Orthosis, Cervical	IQK	1	Complaint file establishment	accessdata.fda.gov
Orthosis, Limb Brace	IQI	1	Complaint file establishment	accessdata.fda.gov
Orthosis, Lumbar	IQE	1	Complaint file establishment	accessdata.fda.gov
Orthosis, Truncal/Orthosis, Limb	MRI	1	Complaint file establishment	accessdata.fda.gov
Oximeter, Infrared, Sporting, Aviation	OCH	2	Complaint file establishment	accessdata.fda.gov
Oximeter, Wellness	PGJ	2	Complaint file establishment	accessdata.fda.gov
Pack, Heat, Moist	IMA	1	Complaint file establishment	accessdata.fda.gov
Pack, Hot Or Cold, Disposable	IMD	1	Complaint file establishment	accessdata.fda.gov
Pack, Hot Or Cold, Reusable	IME	1	Complaint file establishment	accessdata.fda.gov
Pad, Heating, Powered	IRT	2	Complaint file establishment	accessdata.fda.gov
Pill Crusher/Cutter	OHY	1	Complaint file establishment	accessdata.fda.gov
Portable Liquid Oxygen Unit Stand	PCM	1	Complaint file establishment	accessdata.fda.gov
Protector, Hearing (Insert)	EWD	U	Complaint file establishment	accessdata.fda.gov
Protector, Skin Pressure	FMP	1	Complaint file establishment	accessdata.fda.gov
Pump, Breast, Powered	HGX	2	Complaint file establishment	accessdata.fda.gov
Regulator, Pressure, Gas Cylinder	CAN	1	Complaint file establishment	accessdata.fda.gov
Set, Tubing And Support, Ventilator (W Harness)	BZO	1	Complaint file establishment	accessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	HOY	1	Complaint file establishment	accessdata.fda.gov
Splint, Hand, And Components	ILH	1	Complaint file establishment	accessdata.fda.gov
Stand, Infusion	FOX	1	Complaint file establishment	accessdata.fda.gov
Stimulator, Electrical, Non-Implantable, For Incontinence	KPI	2	Complaint file establishment	accessdata.fda.gov
Stimulator, Electrical, Transcutaneous, For Arthritis	NYN	2	Complaint file establishment	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Complaint file establishment	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	Complaint file establishment	accessdata.fda.gov
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine	PCC	2	Complaint file establishment	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain Relief	GZJ	2	Complaint file establishment	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-Counter	NUH	2	Complaint file establishment	accessdata.fda.gov
Stimulator, Neuromuscular, External Functional	GZI	2	Complaint file establishment	accessdata.fda.gov
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat	IMG	2	Complaint file establishment	accessdata.fda.gov
Strap, Head, Gas Mask	BTK	1	Complaint file establishment	accessdata.fda.gov
Strip, Temperature, Forehead, Liquid Crystal	KPD	2	Complaint file establishment	accessdata.fda.gov
Support, Arm	IOY	1	Complaint file establishment	accessdata.fda.gov
Syringe, Irrigating (Non Dental)	KYZ	1	Complaint file establishment	accessdata.fda.gov
Table, Mechanical	INW	1	Complaint file establishment	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Complaint file establishment	accessdata.fda.gov
Tips And Pads, Cane, Crutch And Walker	INP	1	Complaint file establishment	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Complaint file establishment	accessdata.fda.gov
Tubing, Pressure And Accessories	BYX	1	Complaint file establishment	accessdata.fda.gov
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat	IMI	2	Complaint file establishment	accessdata.fda.gov
Unit, Heating, Powered	IRQ	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Urinal	FNP	1	Complaint file establishment	accessdata.fda.gov
Utensil, Eating	ILC	1	Complaint file establishment	accessdata.fda.gov
Ventilator, Non-Continuous (Respirator)	BZD	2	Complaint file establishment	accessdata.fda.gov
Walker, Mechanical	ITJ	1	Complaint file establishment	accessdata.fda.gov
Wheelchair, Mechanical	IOR	1	Complaint file establishment	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 21, 2025	K251130	Portable Oxygen Concentrator (JM-P50A)	CAW	Substantially Equivalent	Jiangsu Jumao X-Care Medical Equipment Co., Ltd.	accessdata.fda.gov
November 9, 2023	K230969	Oxygen Concentrator	CAW	Substantially Equivalent	Jiangsu Jumao X-Care Medical Equipment Co., Ltd.	accessdata.fda.gov
October 5, 2023	K232675	Heating Tens, FT-615	NUH	Substantially Equivalent	Hivox Biotek, Inc.	accessdata.fda.gov
April 26, 2023	K230829	TENS7000 Rechargeable (Model:TENS7000 Rechargeable)	NUH	Substantially Equivalent	Chongqing Rob Linka Science and Technology Co., Ltd.	accessdata.fda.gov
April 8, 2022	K202389	Oxygen Concentrator	CAW	Substantially Equivalent	Foshan Mic Medical Technology Co., Ltd.	accessdata.fda.gov
March 25, 2022	K212395	Nebulizer	CAF	Substantially Equivalent	Shenzhen Homed Medical Device Co., Ltd.	accessdata.fda.gov
February 25, 2022	K213043	Levator Elite (Model LE9011)	IPF	Substantially Equivalent	Shenzhen Dongdixin Technology Co., Ltd.	accessdata.fda.gov
June 17, 2021	K210364	Migraine Tens Digital Pain Reliever	PCC	Substantially Equivalent	Shenzhen Dongdixin Technology Co., Ltd.	accessdata.fda.gov
April 23, 2020	K192358	Pressure Therapy System PT1003	IRP	Substantially Equivalent	Xiamen Senyang Co., Ltd.	accessdata.fda.gov
November 18, 2019	K183393	Digital Thermometer	FLL	Substantially Equivalent	Joytech Healthcare Co. , Ltd.	accessdata.fda.gov
June 21, 2018	K170886	HOMED Mesh Nebulizer	CAF	Substantially Equivalent	Shenzhen Homed Medical Device Co., Ltd.	accessdata.fda.gov
December 8, 2017	K173462	Wireless Pain Relieve Device Model: LT5018C	NUH	Substantially Equivalent	Shenzhen Dongdixin Technology Co., Ltd.	accessdata.fda.gov
October 2, 2017	K171978	Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10	IPF	Substantially Equivalent	Shenzhen Dongdixin Technology Co., Ltd.	accessdata.fda.gov
September 21, 2017	K161719	Salter Labs Bubble Humidifier	BTT	Substantially Equivalent	Salter Labs	accessdata.fda.gov
September 19, 2017	K163518	Digital Thermometer	FLL	Substantially Equivalent	Joytech Healthcare Co. , Ltd.	accessdata.fda.gov
September 6, 2017	K161586	The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS)	CAF	Substantially Equivalent	Shenzhen Homed Medical Device Co., Ltd.	accessdata.fda.gov
May 27, 2016	K153149	Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36	FLL	Substantially Equivalent	Sejoy Electronics & Instruments Co., Ltd.	accessdata.fda.gov
May 5, 2016	K153520	Electronic Pulse Stimulator	NUH	Substantially Equivalent	Jkh Health Co., Ltd.	accessdata.fda.gov
November 13, 2015	K150436	ComboRehab	IMG	Substantially Equivalent	Shenzhen Dongdixin Technology Co., Ltd.	accessdata.fda.gov
August 26, 2015	K142976	UltraTENS	IMI	Substantially Equivalent	Shenzhen Dongdixin Technology Co., Ltd.	accessdata.fda.gov
June 30, 2015	K150591	Besmed Reusable Jet Nebulizer	CAF	Substantially Equivalent	Besmed Health Business Corp	accessdata.fda.gov
November 14, 2014	K141076	GARMENT ELECTRODES	GXY	Substantially Equivalent	Shenzhen Dongdixin Technology Co., Ltd.	accessdata.fda.gov
July 25, 2014	K131720	HIVOX SELF ADHESIVE ELECTRODE GEL PADS	GXY	Substantially Equivalent	Hivox Biotek, Inc.	accessdata.fda.gov
June 16, 2014	K133965	OTC EMS STIMULATOR	NGX	Substantially Equivalent	Shenzhen Dongdixin Technology Co., Ltd.	accessdata.fda.gov
March 14, 2014	K131899	SW-THERM	IMJ	Substantially Equivalent	Shenzhen Dongdixin Technology Co., Ltd.	accessdata.fda.gov
February 26, 2014	K131626	EXCELERON BACTERIAL FILTERS	CAH	Substantially Equivalent	Exceleron Medical	accessdata.fda.gov
December 27, 2013	K131259	LASER-STIM	ILY	Substantially Equivalent	Shenzhen Dongdixin Technology Co., Ltd.	accessdata.fda.gov
December 19, 2013	K123030	COMPRESSOR NEBULIZER MODEL MCN-S600XX	CAF	Substantially Equivalent	Dongguan Aidisy Machinery & Electronic Equipment C	accessdata.fda.gov
November 22, 2013	K132588	ADHESIVE ELECTRODES	GXY	Substantially Equivalent	Top-Rank Health Care Equipment Co., Ltd.	accessdata.fda.gov
September 16, 2013	K130802	OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)	NUH	Substantially Equivalent	Shenzhen Dongdixin Technology Co., Ltd.	accessdata.fda.gov
May 10, 2013	K121719	SM TENS & PMS	NGX	Substantially Equivalent	Hong Qiangxing (Shenzhen) Electronics Limited	accessdata.fda.gov
January 25, 2013	K113375	ESWALLOW USA ELECTRODE,ESWALLOW USA LEADWIRE	GXY	Substantially Equivalent	Eswallow USA	accessdata.fda.gov
November 21, 2012	K120217	SONICSTIMU COMBO THERAPEUTIC DEVICE	IMG	Substantially Equivalent	Shenzhen Dongdixin Technology Co., Ltd.	accessdata.fda.gov
November 20, 2012	K113315	RUMBLE TUFF	HGX	Substantially Equivalent	Acute Ideas Co. , Ltd.	accessdata.fda.gov
July 16, 2012	K120920	HSINER CPAP SILICONE NASAL MASK SIZE XS/PETITE HSINER NASAL PILLOW MASK HSINER INFANT CPAP CANNULA	BZD	Substantially Equivalent	Hsiner Company	accessdata.fda.gov
April 18, 2012	K112816	ZHENJIANG ASURE MECHANICAL WHEELCHAIR	IOR	Substantially Equivalent	Zhenjiang Assure Medical Equipment Co., Ltd.	accessdata.fda.gov
March 8, 2012	K120526	YUYUE K2 WHEELCHAIR, YUYUE K4 WHEELCHAIR	IOR	Substantially Equivalent	Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.	accessdata.fda.gov
September 1, 2011	K112421	EMG SUCTION UNIT	JCX	Substantially Equivalent	Emg Technology Co., Ltd.	accessdata.fda.gov
August 24, 2011	K110776	DIGITAL THERMOMETER MT SERIES	FLL	Substantially Equivalent	Sejoy Electronics & Instruments Co., Ltd.	accessdata.fda.gov
June 10, 2011	K102625	VEGA CPAP SYSTEM/HEATED HUMIDIFIER, MODEL CP-03	BZD	Substantially Equivalent	Vega Technologies, Inc.	accessdata.fda.gov
February 10, 2011	K092202	ESWALLOW DYSPHAGIA THERAPY KIT, PMI DYSPHAGIA THERAPY KIT	IPF	Substantially Equivalent	Eswallow USA	accessdata.fda.gov
November 12, 2010	K102626	VEGA MEDICAL SUCTION EQUIPMENT, MODEL SU-01/SU-DC01	JCX	Substantially Equivalent	Vega Technologies, Inc.	accessdata.fda.gov
March 22, 2010	K094047	18 STANDARD WHEELCHAIR, MODEL MS005-4, 18 RECLINING WHEELCHAIR , MODEL MS008-1, 14 PEDIATRIC WHEELCHAIR	IOR	Substantially Equivalent	Modern Rehabilitation Solutions Co., Ltd.	accessdata.fda.gov
February 12, 2010	K093138	MT9000 SERIES ELECTRO-STIMULATOR, MODELS MT9000, MT9002, MT9001, MT9004 AND MT9003	IPF	Substantially Equivalent	Shenzhen Dongdixin Technology Co., Ltd.	accessdata.fda.gov
February 5, 2010	K091757	OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407	NUH	Substantially Equivalent	Well-Life Healthcare Limited	accessdata.fda.gov
January 29, 2010	K100117	LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR	IPF	Substantially Equivalent	Shenzhen Dongdixin Technology Co., Ltd.	accessdata.fda.gov
January 14, 2010	K092627	CT2011 SONICSTIMU PAIN RELIEF DEVICE	IMG	Substantially Equivalent	Shenzhen Dongdixin Technology Co., Ltd.	accessdata.fda.gov
January 7, 2010	K092780	INF 4160 PLUS, MODEL D-FJ31F	LIH	Substantially Equivalent	Fuji Dynamics Limited	accessdata.fda.gov
November 10, 2009	K091272	BESMED JET NEBULIZER BOTTLE SET	CAF	Substantially Equivalent	Besmed Health Business Corp	accessdata.fda.gov
July 6, 2009	K091482	HUAYI K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4	IOR	Substantially Equivalent	Danyang Huayi Medical Supply & Equipment Co, Ltd.	accessdata.fda.gov
May 13, 2009	K091040	MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IRIDVI-1	FLL	Substantially Equivalent	Microlife Intellectual Property GmbH	accessdata.fda.gov
November 19, 2008	K072634	EMG TRITON -COMP,MODEL NCA01-XXX SERIES	BTI	Substantially Equivalent	Emg Technology Co., Ltd.	accessdata.fda.gov
October 7, 2008	K082784	JUMAO MANUAL WHEELCHAIR	IOR	Substantially Equivalent	Danyang Jumao Healthcare Equipment Co., Ltd.	accessdata.fda.gov
August 22, 2008	K082009	HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS	CAF	Substantially Equivalent	Hsiner Co., Ltd.	accessdata.fda.gov
April 24, 2008	K080005	SPARMAX ASPIRATOR, MODELS TC-2000V ND VC-701	JCX	Substantially Equivalent	Ding Hwa Co., Ltd.	accessdata.fda.gov
March 12, 2008	K080207	DANYANG HUAYI K2 AND K7 WHEELCHAIRS	IOR	Substantially Equivalent	Danyang Huayi Medical Supply & Equipment Co, Ltd.	accessdata.fda.gov
February 15, 2008	K080114	HUAYI H035 BASIC WHEELCHAIR	IOR	Substantially Equivalent	Danyang Huayi Medical Supply & Equipment Co, Ltd.	accessdata.fda.gov
November 27, 2007	K071624	EVERELIFE TRANSCUTANEOUS MUSCLE STIMULATOR	GZJ	Substantially Equivalent	Everlife Medical Equipment Co., Ltd.	accessdata.fda.gov
August 17, 2007	K071320	EVERLIFE POWERED MUSCLE STIMULATOR, MODEL E-100204, E-100504, E-100509, E-100804, E-201111, E-201211, E-201311	IPF	Substantially Equivalent	Everlife Medical Equipment Co., Ltd.	accessdata.fda.gov
May 7, 2007	K070612	TOP-RANK ADHESIVE ELECTRODE	GXY	Substantially Equivalent	Top-Rank Health Care Equipment Co., Ltd.	accessdata.fda.gov
February 23, 2007	K063268	CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235	BZD	Substantially Equivalent	Hsiner Co., Ltd.	accessdata.fda.gov
November 30, 2006	K063448	EMG AC/DC SUCTION UNIT	JCX	Substantially Equivalent	Emg Technology Co., Ltd.	accessdata.fda.gov
July 18, 2006	K060751	INOVO, INC. ACCUPULSE SINGLE LUMEN CONSERVING REGULATOR	NFB	Substantially Equivalent	Inovo, Inc.	accessdata.fda.gov
December 14, 2005	K052087	BREATHING FILTER BACTERIAL/VIRAL, MODEL AG7178	CAH	Substantially Equivalent	Ag Industries	accessdata.fda.gov
October 5, 2005	K052468	YK9000 SERIES MANUAL WHEELCHAIR	IOR	Substantially Equivalent	Intco Metal Products (Zhenjiang) Co., Ltd.	accessdata.fda.gov
May 13, 2005	K050788	EVERLIFE	GXY	Substantially Equivalent	Everlife Medical Instrument Co., Ltd.	accessdata.fda.gov
January 25, 2005	K042578	I-PROMOTIONS CONTACT LENS CASE	LRX	Substantially Equivalent	I-Promotions, Inc.	accessdata.fda.gov
December 16, 2004	K042349	EMG MODEL SUA01 SUCTION UNIT	JCX	Substantially Equivalent	Emg Technology Co., Ltd.	accessdata.fda.gov
April 22, 2004	K040495	NAIMCO, INC., IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 201-400, 201-401, 201-402, 201-403 AND 201-405	EGJ	Substantially Equivalent	Naimco, Inc.	accessdata.fda.gov
April 8, 2004	K040253	EASY MED TN-28 C	GZJ	Substantially Equivalent	Easy Med Instrument Co., Ltd.	accessdata.fda.gov
December 8, 2003	K031018	AUTOGEL PAD	MUI	Substantially Equivalent	Rich-Mar Corp.	accessdata.fda.gov
October 29, 2003	K023000	HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-329M SERIES	IPF	Substantially Equivalent	Home Care Technology Co., Ltd.	accessdata.fda.gov
October 22, 2003	K032941	AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE	IPF	Substantially Equivalent	Rich-Mar Corp.	accessdata.fda.gov
October 7, 2003	K031413	VIGORMIST COMPRESSOR NEBULIZER	BTI	Substantially Equivalent	Vega Technologies, Inc.	accessdata.fda.gov
September 15, 2003	K031983	INOVO, INC, ECONOMIZER CONSERVING REGULATOR	NFB	Substantially Equivalent	Inovo, Inc.	accessdata.fda.gov
September 12, 2003	K030961	MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921	LHD	Substantially Equivalent	Microlife Corp.	accessdata.fda.gov
August 25, 2003	K032018	EASY PULSE II OXYGEN CONSERVER	NFB	Substantially Equivalent	Precision Medical, Inc.	accessdata.fda.gov
January 18, 2002	K013771	MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE	IPF	Substantially Equivalent	Rich-Mar Corp.	accessdata.fda.gov
January 18, 2002	K013770	MODIFICATION TO: WINNER ST-2 STIMULATOR	IPF	Substantially Equivalent	Rich-Mar Corp.	accessdata.fda.gov
October 25, 2001	K012848	WINNER CM4 COMBINATION UNIT	GZJ	Substantially Equivalent	Rich-Mar Corp.	accessdata.fda.gov
October 18, 2001	K012522	WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL	ITX	Substantially Equivalent	National Therapy Products, Inc.	accessdata.fda.gov
September 6, 2001	K010431	LEAD-LOK REUSABLE TENS/ NMES ELECTRODES	GXY	Substantially Equivalent	Lead-Lok, Inc.	accessdata.fda.gov
February 2, 2001	K002227	WANDY SILICONE CONDUCTIVE RUBBER PAD	GXY	Substantially Equivalent	Wandy Rubber Industrial Co., Ltd.	accessdata.fda.gov
January 12, 2001	K003783	MEDICAL DEPOT-WHEELCHAIRS, MODEL SENTRA,ASTAIRE AND VIPER	IOR	Substantially Equivalent	Medical Depot, Inc.	accessdata.fda.gov
August 25, 2000	K000808	RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS DEVICE	IPF	Substantially Equivalent	Rich-Mar Corp.	accessdata.fda.gov
June 6, 2000	K991206	BONASSE CONTACT LENS CASE	LRX	Substantially Equivalent	Bonasse Ent. Co., Ltd.	accessdata.fda.gov
April 29, 1999	K990139	KENSTONE	IOR	Substantially Equivalent	Kenda USA	accessdata.fda.gov
November 19, 1998	K982544	RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICES	IMI	Substantially Equivalent	Rich-Mar Corp.	accessdata.fda.gov
July 10, 1997	K972259	PRO CHECK DIGITAL PACIFIER THERMOMETER	FLL	Substantially Equivalent	Micro Weiss Electronics	accessdata.fda.gov
September 30, 1993	K933406	TRAVEL EASE	IOR	Substantially Equivalent	Merits Health Products., Inc.	accessdata.fda.gov
March 31, 1993	K930411	UNIVERSAL WHEELCHAIR	IOR	Substantially Equivalent	Everest & Jennings, Inc.	accessdata.fda.gov
January 13, 1992	K915262	BANTEX BRAND WHEELCHAIRS	IOR	Substantially Equivalent	Bantex Corp.	accessdata.fda.gov
March 13, 1990	K900997	K-STERILE TENS ELECTRODES	GXY	Substantially Equivalent	Katecho, Inc.	accessdata.fda.gov
February 9, 1988	K875197	OPTIK-AIDS/OPTIC-SHOP THERMAL/THERMA PRO LENS CASE	LRX	Substantially Equivalent	Pro-Optics, Inc.	accessdata.fda.gov
March 16, 1987	K870027	HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER	CCQ	Substantially Equivalent	Salter Labs	accessdata.fda.gov
May 23, 1985	K851146	DIGITAL THERMOMETER	FLL	Substantially Equivalent	Micro Idea Instrument Co., Ltd.	accessdata.fda.gov
March 25, 1980	K800562	DISPOSABLE HAND HELD NEBULIZER	CAF	Substantially Equivalent	Intec Medical, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
March 7, 2023	91923	Class II	Ongoing	REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. Models: DVTREX-U and	Error in the Introduction section of the user manual that indicates the device may be used for the prevention of deep vein thrombosis (DVT). Marketed without a 510k for this indication	accessdata.fda.gov
January 10, 2022	89389	Class II	Ongoing	Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10BL, RLEU10PK, RLEU10WT) RLEU10BL Voyager Rollator Cobalt Blue UPC: 815067078066; RLEU10PK Voyager Rollator Rose Gold UPC: 815067078073; RLEU1	Wheel spoke may crack causing the wheel to separate from the axle may result in patient injuries, including bruising and lacerations requiring stitches.	accessdata.fda.gov
April 8, 2019	82629	Class II	Terminated	MediPress pneumatic compression system, Half Leg-Segmental Gradient, Model #6102-S	Product design change did not receive proper premarket clearance and lacks a 510 (k)	accessdata.fda.gov
June 18, 2018	80545	Class I	Terminated	CPAP Mask Cushion, Model Nos. PB781S, PB781M, PB781L, 781S, 781M and 781L Product Usage: A CPAP mask is attached to an end user s face and a CPAP machine, to treat end users with sleep apnea. The replacement cushion is a	A May 2015 design change in the cushion seal replacement part and accompanying elbow replacement part resulted in incompatibility of the new cushion seal with the previous design of the elbow. Use of the new cushion seal with the previous design elbow could lead to unacceptable CO2 porting. As there was no model number change for this design change, customer	accessdata.fda.gov

Compare with other makers

Updated August 21, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.