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NeuroPro 4 NMES Stimulator

FDA UDI

Class II (US FDA UDI)

by Axiobionics, LLC

Identity

Trade Name
NeuroPro 4 NMES Stimulator FDA UDI
Generic Name
Physical therapy transcutaneous electrical stimulation system, line-powered FDA UDI
Device Name
Neuromuscular Stimulator FDA UDI
Model / Reference
0 FDA UDI
Description
Neuromuscular Stimulator FDA UDI

Identifiers

Catalog Number
11000 FDA UDI
Primary DI / UDI-DI
B36711000L00 FDA UDI
510(k) Number
K900029 FDA UDI
FDA Product Code
IPF FDA UDI
GMDN Term
Physical therapy transcutaneous electrical stimulation system, line-powered FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5850 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Physical therapy transcutaneous electrical stimulation system, line-powered

NeuroPro 4 NMES Stimulator by Axiobionics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Physical therapy transcutaneous electrical stimulation system, line-powered.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Axiobionics, LLC

Sources (1)

  • FDA UDI 59939eca-8b52-412a-b19e-61514b540080 35 fields · synced May 30, 2026