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StimRouter

FDA UDI

Class II (US FDA UDI)

by Bioness Inc.

Identity

Trade Name
StimRouter FDA UDI
Generic Name
Transcutaneous electrical stimulation probe FDA UDI
Device Name
Clinician Programmer Software FDA UDI
Model / Reference
ST2-SW01 FDA UDI
Description
Clinician Programmer Software FDA UDI

Identifiers

Primary DI / UDI-DI
00815962020306 FDA UDI
FDA Product Code
GZF FDA UDI
GMDN Term
Transcutaneous electrical stimulation probe FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5870 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

Yes

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

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Transcutaneous electrical stimulation probe

StimRouter by Bioness Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Transcutaneous electrical stimulation probe.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bioness Inc.

Sources (1)

  • FDA UDI d3ec6f75-51b7-4a78-a4be-85dc8164654a 35 fields · synced Jun 7, 2026