510(k) K263005
- Device
- Electric wheelchair (LW01301A02/LW01301A02L/LW01301A02T)
- Applicant
- Anhui Longway Medical Technology Co., Ltd.
- 510(k) number
- K263005
- Product code
- ITI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-10-28
- Date received
- 2026-08-28
- Regulation
- 890.3860
- Classification name
- Wheelchair, Powered
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- Alan Xie
- Address
- #59 Lingji Rd., Mingguang City 239400, Anhui, China Mingguang CN
FDA Registration Numbers#
- 3011962812
- 3020155847
- 3032171348
- 8030931
- 3038189190
- 3012521614
- 3019842343
- 3017278503
- 3045076265
- 3039359026
- 3010547267
- 3022982004
- 3007675960
- 2937137
- 3006160539
- 9616881
- 1221084
- 3027344674
- 3002667030
- 3033860076
- 3035782854
- 3026585646
- 3021374638
- 8043457
- 3022159079
- 3030822491
- 3003123807
- 3038503938
- 3014983822
- 3003820676
- 3014522447
- 3007771912
- 3016969129
- 3030226288
- 3012274425
- 3039857114
- 3004443928
- 3011969521
- 9618009
- 3033848621
- 3004594214
- 3003857817
- 1531186
- 3003882673
- 9616873
- 3043165991
- 3007963811
- 3036988603
- 3011707750
- 3012425482
- 3043105164
- 3020640553
- 1821729
- 3008466210
- 3014273557
- 3012538618
- 1058069
- 3005619729
- 3030410174
- 3034732597
- 3004730072
- 3009265647
- 3035853002
- 3035111592
- 3005783142
- 3014266593
- 2648727
- 3004141004
- 3013934051
- 3007309323
- 3005260401
- 3008717361
- 3003650116
- 3021959198
- 3027135885
- 3049848766
- 8043717
- 3004024088
- 3021071770
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ITI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261155 | Power Wheelchair (DC07A, DC07S, DC08A, DC08S, DC09, DC09A, DC09S, DC09M, DC10A, DC10S) | Anhui JBH Medical Apparatus Co., Ltd. | 2026-10-26 |
| K261156 | Power Wheelchair (DC07, DC07M, DC08M, DC09F, DC10M) | Anhui JBH Medical Apparatus Co., Ltd. | 2026-10-26 |
| 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 |