K810402 is an FDA 510(k) clearance for the ACE COLD BANDAGE. This device is classified as a Pack, Hot Or Cold, Reusable (Class I - General Controls, product code IME).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Walker, US). The FDA issued a Cleared decision on March 4, 1981, 14 days after receiving the submission on February 18, 1981.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5700.
| 510(k) Number | K810402 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 18, 1981 |
| Decision Date | March 04, 1981 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IME — Pack, Hot Or Cold, Reusable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5700 |