BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair
FDA 510(k) clearance K193599 · decided 2020-09-03
Clearance details
- K-number
- K193599
- Device name
- BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair
- Applicant
- 21st Century Scientific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-12-23
- Decision date
- 2020-09-03
- Days to decision
- 255 days
- Clearance type
- Traditional
- Product code
- ITI
- Device class
- 2
- Regulation number
- 890.3860
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Coeur D'Alene, ID, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Electric Wheelchair (DY611A-2, DY612A-1) (K261149) | Zhejiang Lumbre Electric Appliance Co., Ltd. | 2026-07-10 |
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| Power Wheelchair (W5915B, W5915C, W5915D) (K253812) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2026-06-18 |
| Electric Wheelchair (S500-6) (K260335) | Zhongshan Sulenz Intelligent Technology Co., Ltd. | 2026-06-15 |
| WHILL (WHILL Model C2) (K261175) | Whill, Inc. | 2026-06-12 |
| Power Wheelchair (N5515A, N5516, N5517A, N5519) (K260056) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2026-06-05 |
| Electric Wheelchair (DF506) (K260373) | Jiangsu Yveelt Medical Equipment Co., Ltd. | 2026-06-03 |
| Electric Wheelchair (Y207BL) (K253241) | Jiangsu Intco Medical Products Co., Ltd. | 2026-05-13 |
| Power Wheelchair (N5919 series) (K253806) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2026-04-20 |
| Power Wheelchair (OS-R-M01S) (K253952) | Beijing OrionStar Technology Co., Ltd. | 2026-04-07 |
Recalls involving this device
No recalls on record reference this clearance.