K221653 is an FDA 510(k) clearance for the InfaTherm Disposable Infant Warming Mattress. This device is classified as a Pack, Hot Or Cold, Disposable (Class I - General Controls, product code IMD).
Submitted by International Biomedical (Austin, US). The FDA issued a Cleared decision on October 6, 2022, 121 days after receiving the submission on June 7, 2022.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5710.
| 510(k) Number | K221653 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 2022 |
| Decision Date | October 06, 2022 |
| Days to Decision | 121 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IMD - Pack, Hot Or Cold, Disposable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5710 |