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BioMed Revived II

FDA UDI

Class II (US FDA UDI)

by BioMedical Life Systems Inc.

Identity

Trade Name
BioMed Revived II FDA UDI
Generic Name
Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Device Name
BioMed Revivied II FDA UDI
Model / Reference
BRVE2 FDA UDI
Description
BioMed Revivied II FDA UDI

Identifiers

Catalog Number
BRVE2 FDA UDI
Primary DI / UDI-DI
00857771003996 FDA UDI
510(k) Number
K180956 FDA UDI
K181688 FDA UDI
FDA Product Code
NGX FDA UDI
NUH FDA UDI
GZJ FDA UDI
IPF FDA UDI
GMDN Term
Analgesic transcutaneous electrical nerve stimulation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5850 FDA UDI
882.5890 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

Yes

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

Yes

FDA UDI

Category: Physical therapy transcutaneous neuromuscular electrical stimulation systemAnalgesic transcutaneous electrical nerve stimulation system

BioMed Revived II by BioMedical Life Systems Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Analgesic transcutaneous electrical nerve stimulation system.

Cleared under the same submission

K180956 also covers:

K181688 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
BioMedical Life Systems Inc.

Sources (1)

  • FDA UDI d3dd6324-f140-404c-a6da-4b2794f945f8 36 fields · synced Jun 1, 2026