Blue Hand 02RD Xtfa
Blue Hand 02RD Xtfa is a Class II device made by Bio Protech USA, Inc., cleared under FDA 510(k) K042301 on 3 Sep 2004 and listed in FDA GUDID since 28 Jun 2016 (UDI-DI 00817120020296), 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 | Number00817120020296 | Date28 Jun 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK042301 | Date3 Sep 2004 | StatusActive |
Official records
- AccessGUDID record 00817120020296
- FDA 510(k) database K042301
Across registries
- FDA 510(k) K042301 decided 3 Sep 2004 Active
- FDA GUDID UDI-DI 00817120020296 listed 28 Jun 2016 Listed
Timeline
- Cleared FDA 510(k) K042301
- Listed FDA GUDID 00817120020296
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Blue Hand
- Generic name
- Transcutaneous electrical stimulation electrode, single-use
- Model / reference
- 02RD XTFA
- Primary DI / UDI-DI
- 00817120020296
- 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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