510(k) K152021
K152021 is an FDA 510(k) premarket notification submitted by Proactive Comfort, LLC for the device "Pure Tilt". The FDA issued a decision of Substantially Equivalent on Mar 31, 2016. The device falls under product code IOR (Wheelchair, Mechanical), a Class I device regulated under 21 CFR 890.3850.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 31, 2016
- Date Received
- Jul 21, 2015
- 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
- 510(k)
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.