Data / Medical devices / United States / North Coast Medical, Inc.

North Coast Medical, Inc.: FDA-registered device maker in Morgan Hill, CA, United States, 13 510(k) clearances

Name: North Coast Medical, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

North Coast Medical, Inc. is registered with the FDA (registration 2939821) in Morgan Hill, CA, United States. It lists 51 device types. The FDA files 13 510(k) clearances under its listings, the newest dated January 31, 2025. 4 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 3, 2026.

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Get makers like this one Watch North Coast Medical, Inc.

FDA registration number: 2939821
FEI number: 1000124207
Address: 135 E Main Ave Ste. 110, Morgan Hill, CA, United States, 95037
Owner or operator: NORTH COAST MEDICAL, INC. (9000531)
Roles: Manufacturer, Repackager or relabeler
First device listed: December 15, 1992
Registered through: 2026
Brand names listed: ADL Universal Cuff, Accommodator Insole, Achieva Air Putty, Achieva Ankle Arc, Achieva Smart Mirror, Achieva Sock-Assist, ActivaDose II, ActivaPatch IntelliDose 2.5 and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Wheelchair	KNO	1	Manufacturer	accessdata.fda.gov
Adaptor, Dressing	ILD	1	Manufacturer	accessdata.fda.gov
Adaptor, Recreational	ILT	1	Manufacturer	accessdata.fda.gov
Aid, Transfer	IKX	1	Manufacturer	accessdata.fda.gov
Apparatus, Traction, Non-Powered	HST	1	Manufacturer	accessdata.fda.gov
Bandage, Elastic	FQM	1	Manufacturer	accessdata.fda.gov
Components, Exercise	IOD	1	Manufacturer	accessdata.fda.gov
Container, Sharps	MMK	2	Manufacturer	accessdata.fda.gov
Device, Iontophoresis, Other Uses	EGJ	2	Manufacturer	accessdata.fda.gov
Discriminator, Two-Point	GWI	1	Manufacturer	accessdata.fda.gov
Dressing, Compression	MHW	1	Manufacturer	accessdata.fda.gov
Dynamometer, Nonpowered	HRW	1	Manufacturer	accessdata.fda.gov
Elastomer, Silicone, For Scar Management	MDA	1	Manufacturer	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Manufacturer	accessdata.fda.gov
Esthesiometer	GXB	1	Manufacturer	accessdata.fda.gov
Exerciser, Non-Measuring	ION	1	Manufacturer	accessdata.fda.gov
Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	QKR	N	Manufacturer	accessdata.fda.gov
Fentanyl And Other Opioid Protection Glove	QDO	1	Manufacturer	accessdata.fda.gov
Formulations, Paraffin, All	KEO	1	Manufacturer	accessdata.fda.gov
Gauge, Depth	HTJ	1	Manufacturer	accessdata.fda.gov
Goniometer, Nonpowered	KQW	1	Manufacturer	accessdata.fda.gov
Insoles, Medical	KYS	1	Manufacturer	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Manufacturer	accessdata.fda.gov
Joint, Ankle, External Brace	ITW	1	Manufacturer	accessdata.fda.gov
Joint, Knee, External Brace	ITQ	1	Manufacturer	accessdata.fda.gov
Massager, Therapeutic, Manual	LYG	1	Manufacturer	accessdata.fda.gov
Medical Glove, Specialty	LZC	1	Manufacturer	accessdata.fda.gov
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	OPJ	1	Manufacturer	accessdata.fda.gov
Needle, Acupuncture, Single Use	MQX	2	Manufacturer	accessdata.fda.gov
Orthosis, Corrective Shoe	KNP	1	Manufacturer	accessdata.fda.gov
Orthosis, Limb Brace	IQI	1	Manufacturer	accessdata.fda.gov
Oximeter	DQA	2	Manufacturer	accessdata.fda.gov
Pack, Hot Or Cold, Reusable	IME	1	Manufacturer	accessdata.fda.gov
Pill Crusher/Cutter	OHY	1	Manufacturer	accessdata.fda.gov
Polymer Patient Examination Glove	LZA	1	Manufacturer	accessdata.fda.gov
Protector, Skin Pressure	FMP	1	Manufacturer	accessdata.fda.gov
Sling, Arm	ILI	1	Manufacturer	accessdata.fda.gov
Splint, Hand, And Components	ILH	1	Manufacturer	accessdata.fda.gov
Stimulator, Electro-Acupuncture	BWK	U	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	Manufacturer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-Counter	NUH	2	Manufacturer	accessdata.fda.gov
Stirrup, External Brace Component	ITC	1	Manufacturer	accessdata.fda.gov
Stocking, Elastic	ILG	1	Manufacturer	accessdata.fda.gov
Support, Arm	IOY	1	Manufacturer	accessdata.fda.gov
Table, Mechanical	INW	1	Manufacturer	accessdata.fda.gov
Table, Powered	INQ	1	Manufacturer	accessdata.fda.gov
Tape, Orthopedic	HXT	1	Manufacturer	accessdata.fda.gov
Unit, Wrist, External Limb Component, Mechanical	ISZ	1	Manufacturer	accessdata.fda.gov
Utensil, Eating	ILC	1	Manufacturer	accessdata.fda.gov
Utensil, Homemaking	IKW	1	Manufacturer	accessdata.fda.gov
Vibrator, Therapeutic	IRO	1	Manufacturer	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
January 31, 2025	K243441	Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue)	LZA	Substantially Equivalent	Basic Medical Technology, Inc.	accessdata.fda.gov
November 17, 2021	K211890	Promisemed Sharps container	MMK	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.	accessdata.fda.gov
August 27, 2021	K202861	Needle Stimulator	BWK	Substantially Equivalent	Wuxi Jiajian Medical Instrument Co., Ltd.	accessdata.fda.gov
June 7, 2018	K180956	Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator	NUH	Substantially Equivalent	Shenzhen Roundwhale 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
February 13, 2014	K132832	ACTIVAPATCH ET IONTOPHORESIS PATCH	EGJ	Substantially Equivalent	Activatek, Inc.	accessdata.fda.gov
February 13, 2014	K132422	PALS PLATINUM NEUROSTIMULATION ELECTRODES	GXY	Substantially Equivalent	Axelgaard Mfg. Co., Ltd.	accessdata.fda.gov
July 17, 2013	K130987	VALUTRODE NEUROSTIMLATION ELECTRODES	GXY	Substantially Equivalent	Axelgaard Mfg. Co., Ltd.	accessdata.fda.gov
May 27, 2009	K091326	ACTIVAPATCH	EGJ	Substantially Equivalent	Activatek, Inc.	accessdata.fda.gov
September 12, 2008	K081712	FINGERTIP PULSE OXIMETER, MODEL M70, AND HANDHELD PULSE OXIMETER, MODEL M700	DQA	Substantially Equivalent	Guangdong Biolight Meditech Co., Ltd.	accessdata.fda.gov
August 1, 2006	K061522	TRIVARION BUFFERED IONTOPHORESIS ELECTRODE SYSTEM	EGJ	Substantially Equivalent	Activatek, Inc.	accessdata.fda.gov
May 3, 2002	K020476	MEDION 6000	EGJ	Substantially Equivalent	Selectivemed Components, Inc.	accessdata.fda.gov
January 22, 1998	K974122	ACUPUNCTURE NEEDLE UNDER THE BRAND NAME HWATO AND HUAXIA	MQX	Substantially Equivalent	Scientific Health Care	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
August 18, 2023	93079	Class II	Ongoing	Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC86652 (Medium/Left), NC86653 (Medium/Right), NC86654 (Large/Left), NC86655 (Large/Right), NC86656 (X-Large/Left), and NC8665	The thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the product labeling.	accessdata.fda.gov
August 27, 2021	88613	Class I	Ongoing	Norco Ultrasound Gel, Item/Description: NC70479/Norco Ultrasound Gel, 250 mL; NC70479/North Coast Ultrasound Gel, 250 mL; NC70479-5/Norco Ultrasound Gel, 5 liters; NC70479-5/North Coast Ultrasound Gel, 5 liters; NC70479-	Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-l	accessdata.fda.gov
March 20, 2012	61455	Not yet classified	Terminated	Norco Folding Shower Bench; Features a nonskid surface and handholds for added security. holes allow excess water to drain away easily. Sturdy legs have non-skid rubber feet. Supports up to 200 lbs. North Coast Medical I	Due to a consumer complaint, North Coast Medical determined that due to a design flaw, there was not enough plastic support material to retain bracket bolts when subjected to a force greater than 150 lbs.	accessdata.fda.gov
July 11, 2011	61475	Not yet classified	Terminated	Norco Shoulder Pulley Distributed by North Coast Medical, Gilroy, CA. Used to improve range of shoulder movement and coordination following a stroke, shoulder injury or surgery.	Potential for plastic D-ring to break during use and cause injury.	accessdata.fda.gov

Compare with other makers

Updated January 31, 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.