The following data is part of a premarket notification filed by Thermotek, Inc. with the FDA for Nanotherm, Vascutherm And Prothermo Therapy Wraps.
| Device ID | K061866 |
| 510k Number | K061866 |
| Device Name: | NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPS |
| Classification | Sleeve, Limb, Compressible |
| Applicant | THERMOTEK, INC. 1454 HALSEY WAY Carrollton, TX 75007 |
| Contact | Tony Quisenberry |
| Correspondent | Neil E Devine INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-07-03 |
| Decision Date | 2006-08-22 |
| Summary: | summary |