Axiobionics, LLC, Center for Neuroprosthetics

FDA Device Registration & Listing · Ann Arbor, MI, US · Registration 3008525454

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008525454
FEI Number
3008525454
Entity Name
Axiobionics, LLC, Center for Neuroprosthetics
City/State/Country
Ann Arbor, MI, US
Establishment Address
6111 Jackson Road, Suite 200, Ann Arbor, MI 48103, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Axiobionics, LLC (Owner Number: 9010991)
Owner / Operator Contact Address
6111 Jackson Road, Suite 200, Ann Arbor, MI 48103, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K021100
PMA Number
N/A

All Registered Proprietary Names

Axio 2 channel NMES/TENS Tripleflex Dynamic Orthosis Axiobionics Osteovest Wearable Therapy Free Step NeuroPro 4 Continuum 2 channel NMES/TENS/FES Wearable Therapy 300 PV 2 channel NMES/TENS/FES/IF

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2016-09-23
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2016-09-23
OHI Orthosis, Foot Drop Physical Medicine Class 1 890.3475 2020-09-15
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2010-08-13
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2016-09-23
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2016-09-23
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2015-12-31
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2016-09-23
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2016-09-23
GZI Stimulator, Neuromuscular, External Functional Neurology Class 2 882.5810 2016-09-23
LIH Interferential Current Therapy Neurology Class 2 882.5890 2016-09-23

Official Correspondent

Philip Muccio

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Axiobionics, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K122948 Gemore Technology Co, Ltd. GEM-STIM COMBO STIMULATOR 2012-12-21
K033455 Biomedical Life Systems, Inc. ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5 2004-01-15
K810593 Medical Devices, Inc. NEUROPAC ULTRA I 1981-03-13
K030403 Cefar Medical AB CEFAR REHAB 2 AND REHAB 2 PRO 2003-07-17
K231440 Shenzhen Roundwhale Technology Co. , Ltd. Combo Electrotherapy Device 2023-11-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008525454. Last updated year: 2026. Please use registration number 3008525454 when referencing this establishment in official correspondence.
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