510(k) K193599
- Device
- 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.
- 510(k) number
- K193599
- Product code
- ITI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-09-03
- Date received
- 2019-12-23
- Regulation
- 890.3860
- Classification name
- Wheelchair, Powered
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RD Davidson
- Address
- 4931 N Manufacturing Way Coeur D'Alene ID US 83815 83815
FDA Registration Numbers#
- 3003123807
- 3017278503
- 3019677893
- 3032171348
- 3008370857
- 3032587493
- 3006160539
- 1821729
- 3007675960
- 3012781455
- 3044470904
- 3014653196
- 3004730072
- 9618009
- 3034732597
- 3016969129
- 3043711862
- 3004142507
- 1220973
- 3014983822
- 3038189190
- 3007608806
- 3033796886
- 3005905321
- 3014471045
- 9615410
- 9680333
- 3013934051
- 3007963811
- 3021374638
- 3027344674
- 3019984611
- 3008597995
- 3011969521
- 3014810929
- 3038503938
- 3016195086
- 8043457
- 3036988603
- 3035111592
- 3045076265
- 3033848621
- 9615350
- 3010461764
- 3043105164
- 2531465
- 3007771912
- 3011749761
- 3005619729
- 1221084
- 3021071770
- 3008466210
- 3030410174
- 1531186
- 3008812160
- 3032014158
- 3003650116
- 3001185828
- 3005260401
- 3030671633
- 9616873
- 3011962812
- 3043088974
- 3020155847
- 3014522447
- 3011191255
- 3007309323
- 3004594214
- 2027797
- 3003857817
- 3005783142
- 3022982004
- 3012274425
- 8043717
- 3043165991
- 3003820676
- 3031595780
- 3019842343
- 3014273557
Source Documents#
Other 510(k) Records For Product Code ITI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261149 | Electric Wheelchair (DY611A-2, DY612A-1) | Zhejiang Lumbre Electric Appliance Co., Ltd. | 2026-07-10 |
| K261396 | Electric Wheelchair | Ningbo Resshidi Medical Devices Co., Ltd. | 2026-07-08 |
| K261164 | Electric wheelchair (XW-LY007 ) | Yongkang Ruihe Metal Product Co., Ltd. | 2026-07-07 |
| K260937 | Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK) | Shanghai Waylong Intelligent Technology Co.,Ltd | 2026-06-24 |
| K253812 | Power Wheelchair (W5915B, W5915C, W5915D) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2026-06-18 |
| K260335 | Electric Wheelchair (S500-6) | Zhongshan Sulenz Intelligent Technology Co., Ltd. | 2026-06-15 |
| K261175 | WHILL (WHILL Model C2) | Whill, Inc. | 2026-06-12 |
| K260056 | Power Wheelchair (N5515A, N5516, N5517A, N5519) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2026-06-05 |
| K260373 | Electric Wheelchair (DF506) | Jiangsu Yveelt Medical Equipment Co., Ltd. | 2026-06-03 |
| K253241 | Electric Wheelchair (Y207BL) | Jiangsu Intco Medical Products Co., Ltd. | 2026-05-13 |
| K253806 | Power Wheelchair (N5919 series) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2026-04-20 |
| K253952 | Power Wheelchair (OS-R-M01S) | Beijing OrionStar Technology Co., Ltd. | 2026-04-07 |
| K253340 | Electric Wheelchair (AL-208S-063) | Zhongshan A&J Medical Equipment Co., Ltd. | 2026-04-03 |
| K253307 | Electric wheelchair | Foshan Dahao Medical Technology Co., Ltd. | 2026-03-27 |
| K253980 | Electrically Powered Wheelchair (Model YC-01) | Yurob Rehabilitation Medical Co., Ltd. | 2026-03-27 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases