BodyMed CUS621
by Boxout, LLC
BodyMed CUS621 is a Class II device made by Boxout, LLC, cleared under FDA 510(k) K092546 on 18 Dec 2009 and listed in FDA GUDID since 5 Sep 2016 (UDI-DI 00815802015523), 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 | Number00815802015523 | Date5 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK092546 | Date18 Dec 2009 | StatusActive |
Official records
- AccessGUDID record 00815802015523
- FDA 510(k) database K092546
Across registries
- FDA 510(k) K092546 decided 18 Dec 2009 Active
- FDA GUDID UDI-DI 00815802015523 listed 5 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K092546
- Listed FDA GUDID 00815802015523
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- BodyMed
- Generic name
- Transcutaneous electrical stimulation electrode, single-use
- Model / Ref / Catalog
- CUS621
- Primary DI / UDI-DI
- 00815802015523
- 510(k) Number
- FDA product code
- GXY
- GMDN term
- Transcutaneous electrical stimulation electrode, single-use
- Device class
- Class II
- Regulation number
- 882.1320
- GUDID distribution status
- In Commercial Distribution
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