Contract manufacturerTHERMOTEK, INC. (Flower Mound, TX)TexasGeneral and plastic surgeryClass II
THERMOTEK, INC.
Contract manufacturer ยท Flower Mound, TX
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1648700 (openFDA record; or search FDA's registration database)
- FEI number
- 3000204260
- Registered for
- FDA registration year 2026
- Establishment types
- Specification developer; Manufacturer; Contract manufacturer; Repackager or relabeler
- Owner or operator
- THERMOTEK, INC. (FDA owner/operator no. 9016830)
- Registered address
- 1200 LAKESIDE PKWY STE 200, Flower Mound, TX 75028
- Contract listings
- 1 device listings, 1 product codes, first listed Aug 23, 2019
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| PMC | Scalp Cooling System | Class II | General and plastic surgery | Contract manufacturing | Aug 23, 2019 |