NeuroMD RS-18
NeuroMD RS-18 (RS-18-MD) is a Class II device made by ZMI Electronics Ltd., cleared under FDA 510(k) K220997 on 1 Sep 2022 and listed in FDA GUDID since 15 Jun 2023 (UDI-DI 04719872332503), active as of 23 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 | Number04719872332503 | Date15 Jun 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK220997 | Date1 Sep 2022 | StatusActive |
Official records
- AccessGUDID record 04719872332503
- FDA 510(k) database K220997
Across registries
- FDA 510(k) K220997 decided 1 Sep 2022 Active
- FDA GUDID UDI-DI 04719872332503 listed 15 Jun 2023 Listed
Timeline
- Cleared FDA 510(k) K220997
- Listed FDA GUDID 04719872332503
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- NeuroMD
- Generic name
- Physical therapy transcutaneous neuromuscular electrical stimulation system
- Model / Ref / Catalog
- RS-18, RS-18-MD
- Primary DI / UDI-DI
- 04719872332503
- 510(k) Number
- FDA product code
- NGX
- GMDN term
- Physical therapy transcutaneous neuromuscular electrical stimulation system
- Device class
- Class II
- Regulation number
- 890.5850
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
Similar devices
Other devices filed under FDA product code NGX (Stimulator, Muscle, Powered, For Muscle Conditioning).
- Tens & Ems Device (TU1080) by Changsha Anxiang Medical Technology Co., LTD
- BODY CONTROL SYSTEM FAMILY, BODY CONTROL DUO AND CT5 by Sport-Elec
- TG-BODY MI&BODY S-TRAINER by Miga Medical Co., Ltd.
- TENS and EMS Unit by Changsha Anxiang Medical Technology Co., LTD
- VEINOPLUS SPORT NEUROMUSCULAR STIMULATOR by Ad Rem Technology Sarl
- GEM-TONE BODY TRAINING SYSTEM by GEMORE TECHNOLOGY CO., LTD.
- WELL-LIFE OTC EMS SYSTEM by Well-Life Healthcare, Inc.
- Electromagnetic Stimulation Systems by Shanghai Apolo Medical Technology Co., Ltd
- Silk'n MODEL H5003 device by Home Skinovations, Ltd.
- CONTOUR TECHNOLOGY MUSCLE STIMULATOR by Contour Technology