510(k) K193599
K193599 is an FDA 510(k) premarket notification submitted by 21St Century Scientific, Inc. for the device "BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair". The FDA issued a decision of Substantially Equivalent on Sep 3, 2020. The device falls under product code ITI (Wheelchair, Powered), a Class II device regulated under 21 CFR 890.3860. 21St Century Scientific, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 3, 2020
- Date Received
- Dec 23, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wheelchair, Powered
- Device Class
- Class II
- Regulation Number
- 890.3860
- Review Panel
- PM
- Submission Type
- 510(k)
A powered wheelchair is a battery-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 require an assistive device for mobility. NOTE: This type of device is not intended to climb stairs (see product code: IMK).