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Revitive Advanced

FDA UDI

Class II (US FDA UDI)

by Actegy , Ltd.

Identity

Trade Name
Revitive Advanced FDA UDI
Generic Name
Physical therapy transcutaneous electrical stimulation system, line-powered FDA UDI
Device Name
Neuromuscular Electrical Stimulation Device FDA UDI
Model / Reference
RMV FDA UDI
Description
Neuromuscular Electrical Stimulation Device FDA UDI

Identifiers

Catalog Number
2615 FDA UDI
Primary DI / UDI-DI
00858058005092 FDA UDI
510(k) Number
K152480 FDA UDI
FDA Product Code
NUH FDA UDI
NGX FDA UDI
GMDN Term
Physical therapy transcutaneous electrical stimulation system, line-powered FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5890 FDA UDI
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

No

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 electrical stimulation system, line-powered

Revitive Advanced by Actegy , Ltd. — 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.

Cleared under the same submission

K152480 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Actegy , Ltd.

Sources (1)

  • FDA UDI 6fd71211-df52-4b85-a86a-752bbb70d5bd 37 fields · synced May 30, 2026