BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair
K193599 is the FDA 510(k) clearance record for BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair, a class II device, cleared for 21st Century Scientific, Inc. on under FDA product code ITI (Wheelchair, Powered). FDA's definition for product code ITI reads: "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...". FDA records list 3 510(k) clearances for 21st Century Scientific, Inc., from to . As of , FDA records show no recalls naming K193599.
Clearance record
- Decision date
- Received
- (255 days to decision)
- Product code
- ITI Wheelchair, Powered
- Regulation
- 21 CFR 890.3860
- Device class
- Class II
- Review panel
- Physical Medicine
- Applicant
- 21st Century Scientific, Inc. 4931 N Manufacturing Way, Coeur D'Alene ID
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code ITI
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 3 |
| December 2025 | 3 |
| January 2026 | 2 |
| February 2026 | 3 |
| March 2026 | 7 |
| April 2026 | 3 |
| May 2026 | 1 |
| June 2026 | 6 |
| July 2026 | 3 |
| August 2026 | 1 |
| September 2026 | 4 |
| October 2026 | 0 |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
