RhythmStar RS-10002
RhythmStar RS-10002, an electrocardiographic ambulatory recorder (FDA Class II; FDA product code DXH, Transmitters And Receivers, Electrocardiograph, Telephone) made by RhythMedix, LLC, was cleared under FDA 510(k) K141813 on 5 Aug 2014 and listed in FDA GUDID on 1 Sep 2016 (UDI-DI 00868282000206); the registry lists it as not in commercial distribution (GUDID) 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 | Number00868282000206 | Date1 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK141813 | Date5 Aug 2014 | StatusActive |
Official records
- AccessGUDID record 00868282000206
- FDA 510(k) database K141813
Across registries
- FDA 510(k) K141813 decided 5 Aug 2014 Active
- FDA GUDID UDI-DI 00868282000206 listed 1 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K141813
- Listed FDA GUDID 00868282000206
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- RhythmStar
- Generic name
- Electrocardiographic ambulatory recorder
- Model / reference
- RS-10002
- Primary DI / UDI-DI
- 00868282000206
- 510(k) Number
- FDA product code
- DXH
- GMDN term
- Electrocardiographic ambulatory recorder
- Device class
- Class II
- Regulation number
- 870.2920
- GUDID distribution status
- Not in Commercial Distribution
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