K864158 is an FDA 510(k) clearance for the THERMAPAD. This device is classified as a Bedding, Disposable, Medical (Class I - General Controls, product code KME).
Submitted by Avail-Southwest Division (Dallas, US). The FDA issued a Cleared decision on March 2, 1987, 130 days after receiving the submission on October 23, 1986.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6060.
| 510(k) Number | K864158 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 23, 1986 |
| Decision Date | March 02, 1987 |
| Days to Decision | 130 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | KME — Bedding, Disposable, Medical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6060 |