The following data is part of a premarket notification filed by Henley Intl. with the FDA for Peltiertherapy(c) Heat/cold Treatment.
| Device ID | K871112 |
| 510k Number | K871112 |
| Device Name: | PELTIERTHERAPY(C) HEAT/COLD TREATMENT |
| Classification | Unit, Chilling |
| Applicant | HENLEY INTL. 10518 KINGHURST Houston, TX 77099 |
| Contact | Ernest J Henley |
| Correspondent | Ernest J Henley HENLEY INTL. 10518 KINGHURST Houston, TX 77099 |
| Product Code | IMF |
| CFR Regulation Number | 890.5940 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-19 |
| Decision Date | 1987-05-06 |