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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850033615432 | K061866 | 000 |
| 00850033615203 | K061866 | 000 |
| 00850033615210 | K061866 | 000 |
| 00850033615234 | K061866 | 000 |
| 00850033615241 | K061866 | 000 |
| 00850033615265 | K061866 | 000 |
| 00850033615272 | K061866 | 000 |
| 00850033615296 | K061866 | 000 |
| 00850033615302 | K061866 | 000 |
| 00850033615197 | K061866 | 000 |
| 00850033615180 | K061866 | 000 |
| 00850033615647 | K061866 | 000 |
| 00850033615081 | K061866 | 000 |
| 00850033615104 | K061866 | 000 |
| 00850033615135 | K061866 | 000 |
| 00850033615142 | K061866 | 000 |
| 00850033615159 | K061866 | 000 |
| 00850033615166 | K061866 | 000 |
| 00850033615173 | K061866 | 000 |
| 00850033615319 | K061866 | 000 |
| 00850033615326 | K061866 | 000 |
| 00850033615548 | K061866 | 000 |
| 00850033615579 | K061866 | 000 |
| 00850033615074 | K061866 | 000 |
| 00850033615098 | K061866 | 000 |
| 00850033615111 | K061866 | 000 |
| 00850033615128 | K061866 | 000 |
| 00850033615401 | K061866 | 000 |
| 00850033615418 | K061866 | 000 |
| 00850033615524 | K061866 | 000 |
| 00850033615494 | K061866 | 000 |
| 00850033615333 | K061866 | 000 |
| 00850033615357 | K061866 | 000 |
| 00850033615364 | K061866 | 000 |
| 00850033615395 | K061866 | 000 |
| 00850033615449 | K061866 | 000 |
| 00850033615456 | K061866 | 000 |
| 00850033615463 | K061866 | 000 |
| 00850033615470 | K061866 | 000 |
| 00850033615616 | K061866 | 000 |