Data / Medical devices / United States / Bioness Medical, Inc.

Bioness Medical, Inc.: FDA-registered device maker in Valencia, CA, United States, 7 510(k) clearances

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

Bioness Medical, Inc. is registered with the FDA (registration 3036471706) in Valencia, CA, United States. It lists 8 device types. The FDA files 7 510(k) clearances under its listings, the newest dated March 26, 2021. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3036471706
Address: 25103 Rye Cyn Loop, Valencia, CA, United States, 91355
Owner or operator: Bioness Medical, Inc. (10092201)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: December 12, 2024
Registered through: 2027
Brand names listed: BITS, BITS Balance, BITS Functional Reality, H200 Wireless System, Haloplex System, L100 Go System, L300 Go System, L360 Thigh System and more

Devices it lists

Device	Product code	Class	Role	Source
Electrical Tongue Stimulator To Treat Motor Deficits	QCF	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Exerciser, Measuring	ISD	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Exerciser, Non-Measuring	ION	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Exerciser, Powered	BXB	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Interactive Rehabilitation Exercise Device, Prescription Use	QKC	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Stimulator, Neuromuscular, External Functional	GZI	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Isokinetic Testing And Evaluation	IKK	2	Complaint file establishment, 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
March 26, 2021	DEN200050	Portable Neuromodulation Stimulator (PoNS)	QCF	Unknown	Helius Medical, Inc.	accessdata.fda.gov
March 4, 2020	K200262	L100 Go System	GZI	Substantially Equivalent	Bioness, Inc.	accessdata.fda.gov
September 12, 2019	K191587	L360 Thigh System	GZI	Substantially Equivalent	Bioness, Inc.	accessdata.fda.gov
March 14, 2019	K190285	L300 Go System	GZI	Substantially Equivalent	Bioness, Inc.	accessdata.fda.gov
March 9, 2018	K173682	L300 Go System	GZI	Substantially Equivalent	Bioness, Inc.	accessdata.fda.gov
January 27, 2017	K162407	L300 Go System	GZI	Substantially Equivalent	Bioness, Inc.	accessdata.fda.gov
September 15, 2011	K111767	NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT	GZI	Substantially Equivalent	Ness-Neuromuscular Electrical Stimulation Systems	accessdata.fda.gov

Compare with other makers

Updated March 26, 2021. 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.