K223533 is an FDA 510(k) clearance for the Little Wave Arc. This device is classified as a Stroller, Adaptive (Class I - General Controls, product code LBE).
Submitted by Ki Mobility, LLC (Stevens Point, US). The FDA issued a Cleared decision on August 31, 2023, 281 days after receiving the submission on November 23, 2022.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3850.
| 510(k) Number | K223533 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 2022 |
| Decision Date | August 31, 2023 |
| Days to Decision | 281 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | LBE - Stroller, Adaptive |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.3850 |