Revitive Essential RLV
by Actegy, Ltd.
Revitive Essential RLV (2452) is a Class II device made by Actegy, Ltd., cleared under FDA 510(k) K152480 on 31 Mar 2016 and listed in FDA GUDID since 24 Sep 2020 (UDI-DI 00858058005108), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00858058005108 | Date24 Sep 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK152480 | Date31 Mar 2016 | StatusActive |
Official records
- AccessGUDID record 00858058005108
- FDA 510(k) database K152480
Across registries
- FDA 510(k) K152480 decided 31 Mar 2016 Active
- FDA GUDID UDI-DI 00858058005108 listed 24 Sep 2020 Listed
Timeline
- Cleared FDA 510(k) K152480
- Listed FDA GUDID 00858058005108
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Revitive Essential
- Generic name
- Physical therapy transcutaneous neuromuscular electrical stimulation system
- Model / Ref / Catalog
- RLV, 2452
- Primary DI / UDI-DI
- 00858058005108
- 510(k) Number
- FDA product code
- NUH, NGX
- GMDN term
- Physical therapy transcutaneous neuromuscular electrical stimulation system
- Device class
- Class II
- Regulation number
- 882.5890, 890.5850
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter).
- HIVOX OTC Electrical Stimulator by HIVOX BIOTEK INC.
- 2-in-1 Abdominal Muscle Training & Back Pain Relief System by Tohkai Precision Electrical Manufactory (Shenzhen) Limited
- Transcutaneous Electrical Nerve Stimulator by TOP-RANK HEALTH CARE CO., LTD.
- TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B) by Shenzhen Jiantuo Electronics Co., Ltd.
- iStim S2 OTC Pain Relief TENS by EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
- Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C) by Changsha Anxiang Medical Technology Co., LTD
- Everyway Wireless TENS & EMS Unit by EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
- Heat Pain Pro by Omron Healthcare, Inc.
- Unicare (K-UNICARE-USA) by TensCare Ltd
- Medi-Direct TENS Pen by Jkh USA, LLC