Data / Medical devices / United States / Axiobionics, LLC, Center for Neuroprosthetics

Axiobionics, LLC, Center for Neuroprosthetics: FDA-registered device maker in Ann Arbor, MI, United States, 7 510(k) clearances

Name: Axiobionics, LLC, Center for Neuroprosthetics FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Axiobionics, LLC, Center for Neuroprosthetics is registered with the FDA (registration 3008525454) in Ann Arbor, MI, United States. It lists 6 device types. The FDA files 7 510(k) clearances under its listings, the newest dated November 14, 2014. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Axiobionics, LLC, Center for Neuroprosthetics

FDA registration number: 3008525454
Address: 6111 Jackson Road Suite 200, Ann Arbor, MI, United States, 48103
Owner or operator: Axiobionics, LLC (9010991)
Roles: Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler
First device listed: August 13, 2010
Registered through: 2026
Brand names listed: 300 PV 2 channel NMES/TENS/FES/IF, Axio 2 channel NMES/TENS, Axiobionics, Continuum 2 channel NMES/TENS/FES, Focus 2 channel NMES/TENS/FES, Free Step, NeuroPro 4, Osteovest and more

Devices it lists

Device	Product code	Class	Role	Source
Electrode, Cutaneous	GXY	2	Manufacturer, Remanufacturer, Repackager or relabeler	accessdata.fda.gov
Interferential Current Therapy	LIH	2	Repackager or relabeler	accessdata.fda.gov
Orthosis, Foot Drop	OHI	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Repackager or relabeler	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain Relief	GZJ	2	Repackager or relabeler	accessdata.fda.gov
Stimulator, Neuromuscular, External Functional	GZI	2	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
November 14, 2014	K141342	WEARABLE THERAPY GARMENTS	GXY	Substantially Equivalent	Axiobionics, LLC	accessdata.fda.gov
March 5, 2010	K093324	EMPI CONTINUUM	IPF	Substantially Equivalent	Empi	accessdata.fda.gov
September 5, 2007	K071951	COMFY SERIES: EV-804, EV-805 & EV-806	GZJ	Substantially Equivalent	Everyway Medical Instruments Co.,Ltd	accessdata.fda.gov
June 18, 2002	K021100	300 PV COMPLETE ELECTROTHERAPY SYSTEM	IPF	Substantially Equivalent	Empi	accessdata.fda.gov
May 17, 1996	K951951	FOCUS MODEL 795 UNIT	GZJ	Substantially Equivalent	Empi	accessdata.fda.gov
July 19, 1995	K944543	BIOFLEX GARMENTS, ASSORTED MODELS	GXY	Substantially Equivalent	Bioflex, Inc.	accessdata.fda.gov
April 2, 1990	K900029	SPECTRASTIM 2000 MUSCLE STIMULATOR	IPF	Substantially Equivalent	Therapeutic Technologies, 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
May 27, 2011	59046	Not yet classified	Terminated	AxioBionics Wearable Therapy Upper Extremity BioSleeve (Right and Left) that includes 2-16 BioGel Velcro Electrodes in sizes: 2"x2", 2"x2.5", 2"x3", 2"x3.5", 2"x4", 2"x5", 2"x6", 2"x8", 1.5"x3", 1.5"x5", 1.5"x6", and 1"x	Premature Device Failure : Failure of the electrode sites to conduct and provide muscle stimulation due to silver fabric component failure.	accessdata.fda.gov

Compare with other makers

Updated November 14, 2014. 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.