Ki Mobility Llc
FDA Regulatory Profile
Ki Mobility Llc appears in FDA public data with 1 recall, 5 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0467-2022, Class III) was initiated on November 19, 2021. Its most recent 510(k) clearance was granted on September 5, 2023.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 5
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0467-2022 | Class III | Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is | November 19, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K200583 | Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL | September 5, 2023 |
| K201869 | Ki Power Tilt System | September 5, 2023 |
| K223533 | Little Wave Arc; Little Wave Flip | August 31, 2023 |
| K223527 | Little Wave Clik, Rogue XP, Little Wave XP, Spark | August 31, 2023 |
| K062660 | CATALYSY | October 24, 2006 |