Clearance Summary
BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair received FDA 510(k) clearance under submission number K193599, sponsored by 21st Century Scientific, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2020-09-03.
- Submission: K193599
- Applicant / Sponsor: 21st Century Scientific, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3860
- Decision date: 2020-09-03
Classification & Regulation
This clearance is catalogued under FDA product code ITI and 21 CFR 890.3860, within the Physical Medicine review panel as a Class II device.