K915876 is an FDA 510(k) clearance for the HOTPAD. This device is classified as a Pack, Hot Or Cold, Reusable (Class I - General Controls, product code IME).
Submitted by Ten Comfort Corp. (Taiwan R.O.C., CN). The FDA issued a Cleared decision on February 12, 1993, 421 days after receiving the submission on December 19, 1991.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5700.
| 510(k) Number | K915876 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 1991 |
| Decision Date | February 12, 1993 |
| Days to Decision | 421 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | IME — Pack, Hot Or Cold, Reusable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5700 |