510(k) K200583
K200583 is an FDA 510(k) premarket notification submitted by Ki Mobility, LLC for the device "Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL". The FDA issued a decision of Substantially Equivalent on September 5, 2023. The device falls under product code IOR (Wheelchair, Mechanical), 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
- September 5, 2023
- Date Received
- March 6, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wheelchair, Mechanical
- Device Class
- Class I
- Regulation Number
- 890.3850
- Review Panel
- PM
- Submission Type
A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. FDA interprets mobility to persons restricted to a sitting position to mean the device type is intended to provide mobility to individuals who have mobility impairments and/or require an assistive device for mobility.