K871112 is an FDA 510(k) clearance for the PELTIERTHERAPY(C) HEAT/COLD TREATMENT. This device is classified as a Unit, Chilling (Class I - General Controls, product code IMF).
Submitted by Henley Intl. (Houston, US). The FDA issued a Cleared decision on May 6, 1987, 48 days after receiving the submission on March 19, 1987.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5940.
| 510(k) Number | K871112 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 19, 1987 |
| Decision Date | May 06, 1987 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IMF — Unit, Chilling |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5940 |