Combo Electrotherapy Device
by Shenzhen Roundwhale Technology Co. Ltd.
510(k) K231440
Combo Electrotherapy Device is a medical device (FDA Class II; FDA product code IPF, Stimulator, Muscle, Powered) made by Shenzhen Roundwhale Technology Co. Ltd., cleared under FDA 510(k) K231440 on 3 Nov 2023, 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 | FDA 510(k)SESE | NumberK231440 | Date3 Nov 2023 | StatusActive |
Official records
- FDA 510(k) database K231440
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IPF
- FDA applicant
- Shenzhen Roundwhale Technology Co. , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 890.5850
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K231440
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| ROOVJOY R-C101B | R-C101B | 06971763600506 | — | On the market |
| ROOVJOY R-C101W | R-C101W | 06971763600674 | — | On the market |
Similar devices
Other devices filed under FDA product code IPF (Stimulator, Muscle, Powered).
- HAKOMED ELECDT / PRO ELEDT SERIES by Alive, Inc.
- ULTRA PULSATOR MF by Medelco, Ltd.
- STAODYN EMS/PLUS by Staodynamics, Inc.
- MS 2500 by Lsi Intl., Inc.
- HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch) by Hilltek, LLC
- VITALSTIM EXPERIA by Chattanooga Group, Inc.
- MAXEMS, MODELS 1000 AND 2000 by BIO PROTECH INC.
- HPM-6000 by BTL Industries, Inc.
- RS-4V MUSCLE STIMULATOR by Rs Medical
- STIMTRAC II CATALOG NUMBER 78-8500 by Stimtech Products
Other devices from Shenzhen Roundwhale Technology Co. Ltd.
See all devices from Shenzhen Roundwhale Technology Co. Ltd. →