CoolTone 5040
CoolTone 5040 (CS-MS-002-D-CA) is a deep-tissue electromagnetic stimulation system (FDA Class II; FDA product code NGX, Stimulator, Muscle, Powered, For Muscle Conditioning) made by Zimmer MedizinSysteme GmbH, cleared under FDA 510(k) K220601 on 1 Apr 2022 and listed in FDA GUDID since 15 Sep 2022 (UDI-DI 04053815079187), 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 | Number04053815079187 | Date15 Sep 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK220601 | Date1 Apr 2022 | StatusActive |
Official records
- AccessGUDID record 04053815079187
- FDA 510(k) database K220601
Across registries
- FDA 510(k) K220601 decided 1 Apr 2022 Active
- FDA GUDID UDI-DI 04053815079187 listed 15 Sep 2022 Listed
Timeline
- Cleared FDA 510(k) K220601
- Listed FDA GUDID 04053815079187
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CoolTone
- Generic name
- Deep-tissue electromagnetic stimulation system, professional
- Model / Ref / Catalog
- 5040, CS-MS-002-D-CA
- Primary DI / UDI-DI
- 04053815079187
- 510(k) Number
- FDA product code
- NGX
- GMDN term
- Deep-tissue electromagnetic stimulation system, professional
- Device class
- Class II
- Regulation number
- 890.5850
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code NGX (Stimulator, Muscle, Powered, For Muscle Conditioning).
- FastFit EMS System by Fast Fit, LLC
- Miha Bodytec II by Miha Bodytec GmbH
- Xbody Newave USA by Xbody Hungary Kft.
- Fitness Belt (Model: KLT-07) by Shenzhen Kelutongda Industrial Co., Ltd.
- Muscle Trainer by Shenzhen Kentro Medical Electronics CO.,LTD.
- Portable Electro-Stimulation Therapy Device LGT-232(US) by Guangzhou Longest Science & Technology Co., Ltd.
- BEMER Classic Set, BEMER Pro-Set by Bemer Int. AG
- TriLift 30020000BK by POLLOGEN LTD
- Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13) by Hebei JT Medical Co., Ltd.
- POWERTONE, MODEL PT-11 by Johari Digital Healthcare, Ltd.