510(k) K223533
K223533 is an FDA 510(k) premarket notification submitted by Ki Mobility, LLC for the device "Little Wave Arc; Little Wave Flip". The FDA issued a decision of Substantially Equivalent on August 31, 2023. The device falls under product code LBE (Stroller, Adaptive), a Class I device regulated under 21 CFR 890.3850. Ki Mobility, LLC has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 31, 2023
- Date Received
- November 23, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stroller, Adaptive
- Device Class
- Class I
- Regulation Number
- 890.3850
- Review Panel
- PM
- Submission Type