Stevens Point, WI, US · 4 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| IOR | Wheelchair, Mechanical | Class I | Physical Medicine | 2 | 2023-09-05 |
| ITI | Wheelchair, Powered | Class II | Physical Medicine | 1 | 2023-09-05 |
| LBE | Stroller, Adaptive | Class I | Physical Medicine | 1 | 2023-08-31 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2021-11-19 | Class III | Terminated | Z-0467-2022 | Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually operated … | — | The Instructions for Use provided with the device contained information intended for use of a mechanical wheelchair, not a chair with casters. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2023-09-05 | K201869 | Ki Power Tilt System | ITI | Class II | Physical Medicine |
| 2023-09-05 | K200583 | Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL | IOR | Class I | Physical Medicine |
| 2023-08-31 | K223533 | Little Wave Arc; Little Wave Flip | LBE | Class I | Physical Medicine |
| 2023-08-31 | K223527 | Little Wave Clik, Rogue XP, Little Wave XP, Spark | IOR | Class I | Physical Medicine |