DeRoyal B110.1
DeRoyal B110.1 is a Class II device made by Deroyal Industries, Inc., cleared under FDA 510(k) K052392 on 4 May 2006 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 00749756845885), active as of 23 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 | Number00749756845885 | Date12 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK052392 | Date4 May 2006 | StatusActive |
Official records
- AccessGUDID record 00749756845885
- FDA 510(k) database K052392
Across registries
- FDA 510(k) K052392 decided 4 May 2006 Active
- FDA GUDID UDI-DI 00749756845885 listed 12 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K052392
- Listed FDA GUDID 00749756845885
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- DeRoyal
- Generic name
- Electric pad whole-body heating system
- Model / reference
- B110.1
- Primary DI / UDI-DI
- 00749756845885
- 510(k) Number
- FDA product code
- DWJ
- GMDN term
- Electric pad whole-body heating system
- Device class
- Class II
- Regulation number
- 870.5900
- GUDID distribution status
- In Commercial Distribution
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