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#
- 3026585646
- 3014810929
- 3035782854
- 2027797
- 3032171348
- 1221084
- 3012274425
- 3011707750
- 3043105164
- 3014653196
- 3004730072
- 3005905321
- 3027847712
- 3043088974
- 3020155847
- 3016969129
- 3032014158
- 3010461764
- 8043457
- 3012538618
- 3015989577
- 3008841035
- 3036988603
- 3012425482
- 9616881
- 3013025777
- 3009265647
- 3042501731
- 3011969521
- 3038503938
- 9616873
- 3007309323
- 3014489639
- 3030226288
- 3012521614
- 3020640553
- 3008466210
- 3030671633
- 3033860076
- 3011962812
- 3039857114
- 3003636180
- 3003820676
- 3010547267
- 3015992762
- 3008370857
- 3007771912
- 3022159079
- 3007608806
- 3002667030
- 1531186
- 3004141004
- 3007728095
- 9615350
- 1821729
- 3022982004
- 3030927010
- 3008717361
- 3017278503
- 3035111592
- 9618009
- 3006160539
- 3033848621
- 1058069
- 3021071770
- 3031595780
- 3019984611
- 3001185828
- 3017959212
- 3007963811
- 3004024088
- 3007675960
- 3044470904
- 3014983822
- 3035853002
- 3012781455
- 3005260401
- 3004594214
- 3008812160
Source Documents#
Other 510(k) Records For Product Code ITI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K254206 | Power wheelchair (ZS-EW8026) | Ningbo Zhishan Medical Technology Co., Ltd. | 2026-03-27 |
| K253980 | Electrically Powered Wheelchair (Model YC-01) | Yurob Rehabilitation Medical Co., Ltd. | 2026-03-27 |
| K253307 | Electric wheelchair | Foshan Dahao Medical Technology Co., Ltd. | 2026-03-27 |
| K254012 | Electric Wheelchair (E201) | Nanjing CareMoving Rehabilitation Equipment Co.,Ltd | 2026-03-24 |
| K253849 | Electric wheelchair (JJW-7002, JJW-7003) | ZheJiang J&J Mobility Co., Ltd. | 2026-03-20 |
| K252101 | JWG-1 | Yamaha Motor Co., Ltd. | 2026-03-19 |
| K253870 | Electric Wheelchair (MP148) | Suzhou Master Machinery Manufacturing Co.,Ltd | 2026-03-04 |
| K253789 | Electric wheelchair | Zhejiang Yikang Medical Technology Co., Ltd. | 2026-02-25 |
| K253707 | Electric wheelchair (W1,W3) | Shenzhen Zhimahuaerkai Technology Co., Ltd. | 2026-02-24 |
| K253599 | Electric Wheelchair (W-A807, W-A807L) | Ningbo Shenyu Medical Equipment Co.,Ltd | 2026-02-17 |
| K253276 | Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02) | Shanghai Bangbang Robotics Co., Ltd. | 2026-01-15 |
Legacy Summary#
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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