DeRoyal U102
DeRoyal U102 is a Class II device made by Deroyal Industries, Inc., cleared under FDA 510(k) K092807 on 10 Dec 2009 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 00749756845854), 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 | Number00749756845854 | Date12 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK092807 | Date10 Dec 2009 | StatusActive |
Official records
- AccessGUDID record 00749756845854
- FDA 510(k) database K092807
Across registries
- FDA 510(k) K092807 decided 10 Dec 2009 Active
- FDA GUDID UDI-DI 00749756845854 listed 12 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K092807
- Listed FDA GUDID 00749756845854
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- Withdrawn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
- U102
- Primary DI / UDI-DI
- 00749756845854
- 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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