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#
- 3033848621
- 3012425482
- 9616873
- 1221084
- 3012538618
- 3011523631
- 3014489639
- 3017278503
- 3034732597
- 3043711862
- 3014810929
- 3016195086
- 3044425292
- 3021374638
- 3043105164
- 3004730072
- 9680333
- 3007608806
- 3038189190
- 3014471045
- 1220973
- 3004142507
- 3016969129
- 3008841035
- 2027797
- 3033905189
- 3027847712
- 3015992762
- 3007728095
- 9615350
- 3013025777
- 3012521614
- 1821729
- 3008812160
- 3010461764
- 3011962812
- 3019677893
- 3005260401
- 3006160539
- 3030410174
- 1531186
- 1058069
- 3014522447
- 3014266593
- 3008370857
- 3035111592
- 3039359026
- 3027344674
- 3004024088
- 3008597995
- 3011969521
- 3007309323
- 3014983822
- 3030671633
- 3011749761
- 3031588965
- 3035782854
- 3012781455
- 3004141004
- 3043165991
- 3033796886
- 3030822491
- 8030931
- 8043717
- 9616881
- 3005905321
- 2648727
- 3010547267
- 3032587493
- 3043105518
- 3021959198
- 3044470904
- 3020155847
- 3003123807
- 9618009
- 3011707750
- 3045076265
- 3032014158
- 2937137
- 3004443928
Source Documents#
Other 510(k) Records For Product Code ITI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261169 | Power Wheelchair (D39) | Anhui JBH Medical Apparatus Co., Ltd. | 2026-10-14 |
| K262652 | Electric Wheelchair (CN501) | Zhejiang Shimo Technology Co., Ltd. | 2026-10-13 |
| K263257 | Electrically Powered Wheelchair (YC-01) | Yurob Rehabilitation Medical Co., Ltd. | 2026-10-13 |
| K261079 | Power Wheelchair (DC12) | Anhui JBH Medical Apparatus Co., Ltd. | 2026-10-06 |
| K261200 | Power Wheelchair (D60) | Anhui JBH Medical Apparatus Co., Ltd. | 2026-10-06 |
| K262241 | Electric Wheelchair (0080) | Xuzhou Heabens Medical Technology Co., Ltd. | 2026-09-29 |
| K262582 | Electric wheelchair (GP100) | Suzhou Green Pine Medical Co., Ltd. | 2026-09-23 |
| K262054 | Electric Wheelchair | Yongkang Joymax Medical Technology Co., Ltd. | 2026-09-16 |
| K260053 | Power Wheelchair (OS-R-M01I) | Beijing OrionStar Technology Co., Ltd. | 2026-09-08 |
| K260229 | Electric wheelchair (HC819N, HC830N, HC831N) | Yongkang Hengyi Vehicle Co., Ltd. | 2026-09-08 |
| K261354 | Electric wheelchair (D03) | Foshan Sowell Medical Technology Co., Ltd. | 2026-08-21 |
| 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 |
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