DeRoyal T5037NS-10
DeRoyal T5037NS-10 is a Class II device made by Deroyal Industries, Inc., listed in FDA GUDID since 12 Sep 2016 (UDI-DI 00749756879019), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00749756879019 | Date12 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 00749756879019
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- DeRoyal
- Generic name
- Circulating-fluid localized thermal therapy system control unit
- Model / reference
- T5037NS-10
- Primary DI / UDI-DI
- 00749756879019
- FDA product code
- ILO
- GMDN term
- Circulating-fluid localized thermal therapy system control unit
- Device class
- Class II
- Regulation number
- 890.5720
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code ILO (Pack, hot or cold, water circulating).
- HYPER-K HEAT SYSTEM by Baxter Healthcare Corp
- NICE NICE1 by Nice Recovery Systems, LLC
- GELSKIN by Spenco Medical Corp.
- SPORTS CONTRAST THERAPY SYSTEM ST 7000 by Burke Neutech, Inc.
- IVC SYSTEM by Mark H. Friedman
- CONTRAST 7000 THERAPY SYSTEM by Burke Neutech, Inc.
- COLD/HOT FLUID RADIATION PAD NEUTECH by Burke, Inc.
- STERILE SOFT-TEMP by Adroit Medical Systems, Inc.
- COOL 'N HEAT MACHINE by Kinetic Concepts, Inc.
- AQUA-PAD FOR MOIST OR DRY HEAT THERAPY by Ati