Data / Medical devices / United States / VIVE Health LLC

VIVE Health LLC: FDA-registered device maker in Naples, FL, United States, 79 510(k) clearances

Name: VIVE Health LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

VIVE Health LLC is registered with the FDA (registration 3011191255) in Naples, FL, United States. It lists 116 device types. The FDA files 79 510(k) clearances under its listings, the newest dated December 22, 2025. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3011191255
Address: 8955 Fontana Del Sol Way, Naples, FL, United States, 34109
Owner or operator: VIVE Health LLC (10047487)
Roles: Complaint file establishment, Repackager or relabeler, Specification developer
First device listed: October 5, 2017
Registered through: 2027
Brand names listed: 1" Cane Tip Heavy Duty, 14x13" Ice Wrap, 172 Cervical Collar, 174 Cervical Collar, 180 Cervical Collar, 3 Layer Toe Separators, 3 Wheel Mobility Scooter, 3 Wheel Mobility Scooter (MOB1025) and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Wheelchair	KNO	1	Repackager or relabeler	accessdata.fda.gov
Adaptor, Dressing	ILD	1	Repackager or relabeler	accessdata.fda.gov
Adaptor, Grooming	ILW	1	Repackager or relabeler	accessdata.fda.gov
Adaptor, Hygiene	ILS	1	Repackager or relabeler	accessdata.fda.gov
Aid, Transfer	IKX	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Analyzer, Body Composition	MNW	2	Repackager or relabeler	accessdata.fda.gov
Analyzer, Body Composition, Exempt	PUH	2	Repackager or relabeler	accessdata.fda.gov
Armrest, Wheelchair	IML	1	Repackager or relabeler	accessdata.fda.gov
Attachment, Commode, Wheelchair	INB	1	Repackager or relabeler	accessdata.fda.gov
Bag, Drainage, With Adhesive, Ostomy	FON	1	Repackager or relabeler	accessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, Sterile	FAQ	1	Repackager or relabeler	accessdata.fda.gov
Band Or Belt, Pelvic Support	ISR	1	Repackager or relabeler	accessdata.fda.gov
Bandage, Cast	ITG	1	Repackager or relabeler	accessdata.fda.gov
Bandage, Elastic	FQM	1	Repackager or relabeler	accessdata.fda.gov
Bandage, Liquid, Skin Protectant	NEC	1	Repackager or relabeler	accessdata.fda.gov
Basin, Emesis	FNY	1	Repackager or relabeler	accessdata.fda.gov
Bedpan	FOB	1	Repackager or relabeler	accessdata.fda.gov
Binder, Breast	HEF	1	Repackager or relabeler	accessdata.fda.gov
Binder, Medical, Therapeutic	MDR	1	Repackager or relabeler	accessdata.fda.gov
Blood Pressure Cuff	DXQ	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Brake, Extension, Wheelchair	IMW	1	Repackager or relabeler	accessdata.fda.gov
Cane	IPS	1	Repackager or relabeler	accessdata.fda.gov
Cannula, Surgical, General & Plastic Surgery	GEA	1	Repackager or relabeler	accessdata.fda.gov
Chair, Geriatric	FRJ	1	Repackager or relabeler	accessdata.fda.gov
Chair, Positioning, Electric	INO	2	Repackager or relabeler	accessdata.fda.gov
Chair, With Casters	INM	1	Repackager or relabeler	accessdata.fda.gov
Cleanser, Denture, Over The Counter	EFT	1	Repackager or relabeler	accessdata.fda.gov
Clinical Electronic Thermometer	SDV	2	Repackager or relabeler	accessdata.fda.gov
Components, Exercise	IOD	1	Repackager or relabeler	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Repackager or relabeler	accessdata.fda.gov
Cover, Cast	KIA	1	Repackager or relabeler	accessdata.fda.gov
Cover, Mattress (Medical Purposes)	FMW	1	Repackager or relabeler	accessdata.fda.gov
Crutch	IPR	1	Repackager or relabeler	accessdata.fda.gov
Cushion, Flotation	KIC	1	Repackager or relabeler	accessdata.fda.gov
Cushion, Wheelchair	IMP	1	Repackager or relabeler	accessdata.fda.gov
Device, Patient Transfer, Powered	FRZ	2	Repackager or relabeler	accessdata.fda.gov
Dressing, Compression	MHW	1	Repackager or relabeler	accessdata.fda.gov
Dressing, Wound, Drug	FRO	U	Repackager or relabeler	accessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or Biologic	NAE	1	Repackager or relabeler	accessdata.fda.gov
Dressing, Wound, Hydrophilic	NAC	1	Repackager or relabeler	accessdata.fda.gov
Dressing, Wound, Occlusive	NAD	1	Repackager or relabeler	accessdata.fda.gov
Elastomer, Silicone, For Scar Management	MDA	1	Repackager or relabeler	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Repackager or relabeler	accessdata.fda.gov
Exerciser, Non-Measuring	ION	1	Repackager or relabeler	accessdata.fda.gov
Fentanyl And Other Opioid Protection Glove	QDO	1	Repackager or relabeler	accessdata.fda.gov
Footrest, Wheelchair	IMM	1	Repackager or relabeler	accessdata.fda.gov
Garment, Protective, For Incontinence	EYQ	1	Repackager or relabeler	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Repackager or relabeler	accessdata.fda.gov
Generator, Oxygen, Portable	CAW	2	Repackager or relabeler	accessdata.fda.gov
Helmet, Cranial, For Protective Use	NDA	1	Repackager or relabeler	accessdata.fda.gov
Insoles, Medical	KYS	1	Repackager or relabeler	accessdata.fda.gov
Joint, Ankle, External Brace	ITW	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Joint, Hip, External Brace	ITS	1	Repackager or relabeler	accessdata.fda.gov
Joint, Knee, External Brace	ITQ	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Lift, Patient, Ac-Powered	FNG	2	Repackager or relabeler	accessdata.fda.gov
Massager, Powered Inflatable Tube	IRP	2	Repackager or relabeler, Specification developer	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Repackager or relabeler	accessdata.fda.gov
Massager, Therapeutic, Manual	LYG	1	Repackager or relabeler	accessdata.fda.gov
Mattress, Air Flotation, Alternating Pressure	FNM	2	Repackager or relabeler	accessdata.fda.gov
Mattress, Flotation Therapy, Non-Powered	IKY	1	Repackager or relabeler	accessdata.fda.gov
Medical Glove, Specialty	LZC	1	Repackager or relabeler	accessdata.fda.gov
Multiple Use Blood Lancet For Single Patient Use Only	QRL	2	Repackager or relabeler	accessdata.fda.gov
Nebulizer (Direct Patient Interface)	CAF	2	Repackager or relabeler	accessdata.fda.gov
Orthosis, Cervical	IQK	1	Repackager or relabeler	accessdata.fda.gov
Orthosis, Corrective Shoe	KNP	1	Repackager or relabeler	accessdata.fda.gov
Orthosis, Foot Drop	OHI	1	Repackager or relabeler	accessdata.fda.gov
Orthosis, Limb Brace	IQI	1	Repackager or relabeler	accessdata.fda.gov
Orthosis, Lumbar	IQE	1	Repackager or relabeler	accessdata.fda.gov
Orthosis, Thoracic	IPT	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Orthosis, Truncal/Orthosis, Limb	MRI	1	Repackager or relabeler	accessdata.fda.gov
Oximeter	DQA	2	Repackager or relabeler	accessdata.fda.gov
Pack, Heat, Moist	IMA	1	Repackager or relabeler	accessdata.fda.gov
Pack, Hot Or Cold, Disposable	IMD	1	Repackager or relabeler	accessdata.fda.gov
Pack, Hot Or Cold, Reusable	IME	1	Repackager or relabeler	accessdata.fda.gov
Pack, Hot Or Cold, Water Circulating	ILO	2	Repackager or relabeler, Specification developer	accessdata.fda.gov
Pad, Heating, Powered	IRT	2	Repackager or relabeler	accessdata.fda.gov
Polymer Patient Examination Glove	LZA	1	Repackager or relabeler	accessdata.fda.gov
Protector, Ostomy	EXE	1	Repackager or relabeler	accessdata.fda.gov
Protector, Skin Pressure	FMP	1	Repackager or relabeler	accessdata.fda.gov
Pump, Breast, Powered	HGX	2	Repackager or relabeler	accessdata.fda.gov
Restraint, Protective	FMQ	1	Repackager or relabeler	accessdata.fda.gov
Scale, Stand-On, Patient	FRI	1	Repackager or relabeler	accessdata.fda.gov
Scissors, Medical, Disposable	JOK	1	Repackager or relabeler	accessdata.fda.gov
Shoe, Cast	IPG	1	Repackager or relabeler	accessdata.fda.gov
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	FMK	2	Repackager or relabeler	accessdata.fda.gov
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	QRK	2	Repackager or relabeler	accessdata.fda.gov
Sleeve, Limb, Compressible	JOW	2	Specification developer	accessdata.fda.gov
Sling, Arm	ILI	1	Repackager or relabeler	accessdata.fda.gov
Sling, Arm, Overhead Supported	ILE	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Solvent, Adhesive Tape	KOX	1	Repackager or relabeler	accessdata.fda.gov
Splint, Hand, And Components	ILH	1	Repackager or relabeler	accessdata.fda.gov
Stand, Infusion	FOX	1	Repackager or relabeler	accessdata.fda.gov
Stethoscope, Manual	LDE	1	Repackager or relabeler	accessdata.fda.gov
Stimulator, Electrical, Transcutaneous, For Arthritis	NYN	2	Repackager or relabeler	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Repackager or relabeler	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	Repackager or relabeler	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain Relief	GZJ	2	Repackager or relabeler	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-Counter	NUH	2	Repackager or relabeler	accessdata.fda.gov
Stocking, Elastic	ILG	1	Repackager or relabeler	accessdata.fda.gov
Stocking, Medical Support (For General Medical Purposes)	FQL	1	Repackager or relabeler	accessdata.fda.gov
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)	DWL	2	Repackager or relabeler	accessdata.fda.gov
Support, Arm	IOY	1	Repackager or relabeler	accessdata.fda.gov
Suprapubic Catheter Accessories	QGC	1	Repackager or relabeler	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Repackager or relabeler	accessdata.fda.gov
System, Test, Blood Glucose, Over The Counter	NBW	2	Repackager or relabeler	accessdata.fda.gov
Table, Mechanical	INW	1	Repackager or relabeler	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Repackager or relabeler	accessdata.fda.gov
Tips And Pads, Cane, Crutch And Walker	INP	1	Repackager or relabeler	accessdata.fda.gov
Tubing, Pressure And Accessories	BYX	1	Repackager or relabeler	accessdata.fda.gov
Utensil, Eating	ILC	1	Repackager or relabeler	accessdata.fda.gov
Vehicle, Motorized 3-Wheeled	INI	2	Repackager or relabeler	accessdata.fda.gov
Ventilator, Non-Continuous (Respirator)	BZD	2	Repackager or relabeler	accessdata.fda.gov
Walker, Mechanical	ITJ	1	Repackager or relabeler	accessdata.fda.gov
Wheelchair, Mechanical	IOR	1	Repackager or relabeler	accessdata.fda.gov
Wheelchair, Powered	ITI	2	Repackager or relabeler	accessdata.fda.gov
Wound Dressing With Animal-Derived Material(S)	KGN	U	Repackager or relabeler	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
December 22, 2025	K251159	Power wheelchair	ITI	Substantially Equivalent	Zhenjiang Assure Medical Equipment Co., Ltd.	accessdata.fda.gov
October 3, 2025	K252517	Manual Wheelchair (SYIV100A008)	IOR	Substantially Equivalent	Ningbo Shenyu Medical Equipment Co.,Ltd	accessdata.fda.gov
August 21, 2025	K251130	Portable Oxygen Concentrator (JM-P50A)	CAW	Substantially Equivalent	Jiangsu Jumao X-Care Medical Equipment Co., Ltd.	accessdata.fda.gov
August 8, 2025	K250817	Coretech Compression System (Coretech RHB3003)	JOW	Substantially Equivalent	Vive Health, LLC	accessdata.fda.gov
July 22, 2025	K251638	Mobility Scooter (MS160C)	INI	Substantially Equivalent	Suzhou Master Machinery Manufacturing Co.,Ltd	accessdata.fda.gov
June 5, 2025	K242736	Portable Oxygen Concentrator (Spirit-3)	CAW	Substantially Equivalent	Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.	accessdata.fda.gov
May 30, 2025	K250368	Wearable Breast Pump (Model S21)	HGX	Substantially Equivalent	Shenzhen TPH Technology Co., Ltd.	accessdata.fda.gov
January 31, 2025	K242982	Mobility Scooter (MS160A)	INI	Substantially Equivalent	Suzhou Master Machinery Manufacturing Co.,Ltd	accessdata.fda.gov
November 18, 2024	K242471	Power Wheelchair (W5538)	ITI	Substantially Equivalent	Zhejiang Innuovo Rehabilitation Devices Co.,Ltd	accessdata.fda.gov
November 12, 2024	K242791	Electric wheelchair (KR-8807)	ITI	Substantially Equivalent	Zhejiang Kairui Medical Device Co., Ltd.	accessdata.fda.gov
August 7, 2024	K240255	Electric Wheelchair (JLE-W01A-2023)	ITI	Substantially Equivalent	Zhejiang Jianrui Technology Company Limited	accessdata.fda.gov
August 2, 2024	K240981	Air compression leg massager	IRP	Substantially Equivalent	Huizhou Xinyi Technology Co., Ltd.	accessdata.fda.gov
July 19, 2024	K233067	Wireless TENS & EMS (Model SM9110,SM9113,SM9116)	NUH	Substantially Equivalent	Chongqing Rob Linka Science and Technology Co., Ltd.	accessdata.fda.gov
June 5, 2024	K240008	Mobility Scooter (W3331)	INI	Substantially Equivalent	Zhejiang Innuovo Rehabilitation Devices Co.,Ltd	accessdata.fda.gov
May 31, 2024	K240913	Electric Wheelchair (HBLD3-B); Electric Wheelchair (HBLD3-E)	ITI	Substantially Equivalent	Shanghai Hubang Intelligent Rehabilitation Equipment Co.,Ltd	accessdata.fda.gov
May 2, 2024	K240012	Mobility Scooter (W3431)	INI	Substantially Equivalent	Zhejiang Innuovo Rehabilitation Devices Co.,Ltd	accessdata.fda.gov
April 25, 2024	K232796	LUOFUCON® Collagen Particles (Collagen Wound Dressing)	KGN	Substantially Equivalent	Huizhou Foryou Medical Devices Co., Ltd.	accessdata.fda.gov
February 12, 2024	K233092	Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)	NUH	Substantially Equivalent	Chongqing Rob Linka Science and Technology Co., Ltd.	accessdata.fda.gov
January 19, 2024	K232783	Power wheelchair (Model: JMPW-01W)	ITI	Substantially Equivalent	Jiangsu Jumao X-Care Medical Equipment Co., Ltd.	accessdata.fda.gov
January 4, 2024	K221110	LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing	FRO	Substantially Equivalent	Huizhou Foryou Medical Devices Co., Ltd.	accessdata.fda.gov
November 28, 2023	K232713	Blood Pressure Monitor	DXN	Substantially Equivalent	Guangdong Transtek Medical Electronics Co., Ltd.	accessdata.fda.gov
November 10, 2023	K231564	Skin and Wound Cleanser	FRO	Substantially Equivalent	Winner Medical Co., Ltd.	accessdata.fda.gov
November 9, 2023	K231508	Power Wheelchair, W5521	ITI	Substantially Equivalent	Zhejiang Innuovo Rehabilitation Devices Co.,Ltd	accessdata.fda.gov
September 15, 2023	K232199	Bariatric Heavy Duty Wheelchair (YJ-010B 20DS; YJ-010B 20DE; YJ-010B 20DFS; YJ-010B 20DFE;YJ-010B 20ADS; YJ-010B 20ADE; YJ-010B 20ADFS; YJ-010B 20ADFE; YJ-010B 22DS; YJ-010B 22DE; YJ-010B 22DFS;YJ-010B 22DFE; YJ-010B 22ADS;YJ-010B 22ADE; YJ-010B 22ADFS; YJ-010B 22ADFE; YJ-010B 24DS; YJ-010B 24DE; YJ-010B 24DFS; YJ-010B 24DFE; YJ-010B 24ADS; YJ-010B 24ADE; YJ-010B 22ADFS; YJ-010B 24ADFE)	IOR	Substantially Equivalent	Zhenjiang Assure Medical Equipment Co., Ltd.	accessdata.fda.gov
September 15, 2023	K232198	Reclining wheelchair (YJ-011S 16D, YJ-011S 16DF, YJ-011S 18D, YJ-011S 18DF, YJ-011S 20D, YJ-011S 20DF)	IOR	Substantially Equivalent	Zhenjiang Assure Medical Equipment Co., Ltd.	accessdata.fda.gov
July 14, 2023	K231428	Mobility Scooter (Models: W3431D)	INI	Substantially Equivalent	Zhejiang Innuovo Rehabilitation Devices Co.,Ltd	accessdata.fda.gov
June 16, 2023	K231110	Manual Wheelchair (A006)	IOR	Substantially Equivalent	Ningbo Shenyu Medical Equipment Co.,Ltd	accessdata.fda.gov
December 1, 2022	K222125	Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G	DXN	Substantially Equivalent	Shenzhen AOJ Medical Technology Co., Ltd.	accessdata.fda.gov
November 29, 2022	K222408	Disposable Safety Lancet	FMK	Substantially Equivalent	Beijing Ruicheng Medical Supplies Co., Ltd.	accessdata.fda.gov
September 20, 2022	K213598	LUOFUCON Collagen Wound Dressing	KGN	Substantially Equivalent	Huizhou Foryou Medical Devices Co., Ltd.	accessdata.fda.gov
September 7, 2022	K222034	RightLance Blood Lancing System	QRL	Substantially Equivalent	Beijing Ruicheng Medical Supplies Co., Ltd.	accessdata.fda.gov
July 27, 2022	K220886	Upper Arm Type Blood Pressure Monitor	DXN	Substantially Equivalent	Shenzhen Jamr Technology Co., Ltd.	accessdata.fda.gov
April 22, 2022	K211123	LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel	FRO	Substantially Equivalent	Huizhou Foryou Medical Devices Co., Ltd.	accessdata.fda.gov
July 2, 2021	K203347	Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow Mask	BZD	Substantially Equivalent	Suzhou Yuyue Medical Technology Co., Ltd.	accessdata.fda.gov
March 25, 2021	K201982	Air compression therapy system FO-3001; Air compression therapy system FO-3008	IRP	Substantially Equivalent	Foshan Hongfeng Co., Ltd.	accessdata.fda.gov
March 25, 2021	K200177	Low-frequency Multi-function physiotherapy instrument	NUH	Substantially Equivalent	Shenzhen Kentro Medical Electronics Co., Ltd.	accessdata.fda.gov
March 9, 2021	K202891	Blood Pressure Monitor	DXN	Substantially Equivalent	Guangdong Transtek Medical Electronics Co., Ltd.	accessdata.fda.gov
December 17, 2020	K200346	Wrist Type Blood Pressure Monitor	DXN	Substantially Equivalent	Avita Corporation	accessdata.fda.gov
December 11, 2020	K201354	TENS & PMS	NGX	Substantially Equivalent	Hong Qiangxing (Shenzhen) Electronics Limited	accessdata.fda.gov
April 6, 2020	K200019	Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black)	LZA	Substantially Equivalent	Hartalega NGC Sdn. Bhd.	accessdata.fda.gov
March 20, 2020	K191657	Bioland Blood Glucose Monitoring System	NBW	Substantially Equivalent	Bioland Technology, Ltd.	accessdata.fda.gov
January 16, 2020	K191802	Electric Breast Pump	HGX	Substantially Equivalent	Ningbo Huiyoo Baby Products Co., Ltd.	accessdata.fda.gov
November 1, 2019	K192087	Combo Electrotherapy Device	NUH	Substantially Equivalent	Shenzhen Roundwhale Technology Co. , Ltd.	accessdata.fda.gov
September 13, 2019	K181478	Roosin Xeroform Petrolatum Dressing	FRO	Substantially Equivalent	Roosin Medical Co., Ltd.	accessdata.fda.gov
July 30, 2019	K183288	Transcutaneous Electrical Nerve Stimulator	NUH	Substantially Equivalent	Shenzhen Kentro Medical Electronics Co., Ltd.	accessdata.fda.gov
June 24, 2019	K182411	Scooter, Model: R-100	INI	Substantially Equivalent	Yongkang Dingchang Industry & Trade Co., Ltd.	accessdata.fda.gov
March 3, 2019	K182495	Electronic Blood Pressure Monitor	DXN	Substantially Equivalent	Shenzhen Jumper Medical Equipment Co., Ltd.	accessdata.fda.gov
October 29, 2018	K181239	Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer	FLL	Substantially Equivalent	Joytech Healthcare Co. , Ltd.	accessdata.fda.gov
September 7, 2018	K181688	R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator	IPF	Substantially Equivalent	Shenzhen Roundwhale Technology Co. , Ltd.	accessdata.fda.gov
April 4, 2018	K172141	Pulse Oximeter	DQA	Substantially Equivalent	Shanghai Berry Electronic Tech Co., Ltd.	accessdata.fda.gov
December 19, 2017	K171889	Reusable Blood Pressure Cuff	DXQ	Substantially Equivalent	Suzhou Minhua Medical Apparatus Supplies Co., Ltd.	accessdata.fda.gov
November 30, 2017	K171578	Infrared thermometer	FLL	Substantially Equivalent	Shenzhen Aeon Technology Co., Ltd.	accessdata.fda.gov
November 3, 2017	K170965	Fingertip Pulse Oximeter	DQA	Substantially Equivalent	Shenzhen Jumper Medical Equipment Co., Ltd.	accessdata.fda.gov
October 27, 2017	K170466	Automatic Blood Pressure Monitor Model LD-518 & LD-537	DXN	Substantially Equivalent	Honsun (Nantong) 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 11, 2017	K170205	Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203	NUH	Substantially Equivalent	Shenzhen Kentro Medical Electronics Co., Ltd.	accessdata.fda.gov
May 8, 2017	K161938	Fingertip Pulse Oximeter	DQA	Substantially Equivalent	Xuzhou Yongkang Electronic Science Technology Co., Ltd.	accessdata.fda.gov
October 30, 2016	K161282	FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W	GXY	Substantially Equivalent	Medico Electrodes International , 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
January 26, 2015	K143124	KA01 Chitosan Wound Dressing	KGN	Substantially Equivalent	Foshan United Medical Technologies, Ltd.	accessdata.fda.gov
February 28, 2014	K130982	LERADO, POWER WHEELCHAIR	ITI	Substantially Equivalent	Lerado Global (Macao Commercial Offshore) Limited	accessdata.fda.gov
December 19, 2013	K123030	COMPRESSOR NEBULIZER MODEL MCN-S600XX	CAF	Substantially Equivalent	Dongguan Aidisy Machinery & Electronic Equipment C	accessdata.fda.gov
May 10, 2013	K121719	SM TENS & PMS	NGX	Substantially Equivalent	Hong Qiangxing (Shenzhen) Electronics Limited	accessdata.fda.gov
February 14, 2013	K120181	LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM	FRO	Substantially Equivalent	Huizhou Foryou Medical Devices Co., Ltd.	accessdata.fda.gov
January 4, 2013	K122976	BODY FAT SCALE MODEL SF-371	MNW	Substantially Equivalent	Shenzhen Belter Health Measurement and Analysis TE	accessdata.fda.gov
April 18, 2012	K112816	ZHENJIANG ASURE MECHANICAL WHEELCHAIR	IOR	Substantially Equivalent	Zhenjiang Assure Medical Equipment Co., Ltd.	accessdata.fda.gov
December 16, 2010	K102624	AVITA WRIST TYPE BLOOD PRESSURE MONITOR	DXN	Substantially Equivalent	Avita Corporation	accessdata.fda.gov
December 2, 2009	K091578	LIFT CHAIR, MODEL T3	INO	Substantially Equivalent	Pride Mobility Products Corp.	accessdata.fda.gov
October 28, 2009	K092245	ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE, MODEL LD-100	DXQ	Substantially Equivalent	Honsun (Nantong) Co., Ltd.	accessdata.fda.gov
November 10, 2008	K082641	FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL	DQA	Substantially Equivalent	Contec Medical System Co., Ltd.	accessdata.fda.gov
September 17, 2008	K082542	ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE MODEL HBPK-A	DXQ	Substantially Equivalent	Cardicare Company, Ltd.	accessdata.fda.gov
March 23, 2007	K062033	BP 101 DIGITAL BLOOD PRESSURE MONITOR	DXN	Substantially Equivalent	Kingyield Hongkong Limited	accessdata.fda.gov
March 22, 2007	K070501	RUIKE 3421 POWERED WHEELCHAIR	ITI	Substantially Equivalent	Shanghai Ruike Sports Goods Co., Ltd.	accessdata.fda.gov
February 5, 2007	K062646	RUIKE, MODEL 3411	INI	Substantially Equivalent	Shanghai Ruike Sports Goods Co., Ltd.	accessdata.fda.gov
December 19, 2006	K062645	RUIKE, MODEL 3431	INI	Substantially Equivalent	Shanghai Ruike Sports Goods Co., Ltd.	accessdata.fda.gov
December 14, 2006	K062676	RUIKE, MODEL 3331	INI	Substantially Equivalent	Shanghai Ruike Sports Goods Co., Ltd.	accessdata.fda.gov
February 6, 2006	K051699	SEJOY, MODEL MT-403	FLL	Substantially Equivalent	Sejoy Electronics & Instruments Co., Ltd.	accessdata.fda.gov
January 25, 2006	K053574	MEDLINE PEDIATRIC WHEELCHAIRS	IOR	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
July 6, 2005	K043238	COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES	CAF	Substantially Equivalent	Emg Technology Co., Ltd.	accessdata.fda.gov

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Updated December 22, 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.