510(k) K261149
- Device
- Electric Wheelchair (DY611A-2, DY612A-1)
- Applicant
- Zhejiang Lumbre Electric Appliance Co., Ltd.
- 510(k) number
- K261149
- Product code
- ITI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-07-10
- Date received
- 2026-04-08
- 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
- N
Applicant Contact#
- Contact
- Yubiao Chen
- Address
- #236, Shanhe Rd., Huzhen Town, Jinyun County, Lishui City, Z Lishui CN
FDA Registration Numbers#
- 3045076265
- 3020640553
- 3011969521
- 3019677893
- 3016195086
- 3013934051
- 3033905189
- 3012781455
- 3020155847
- 3003882673
- 9616881
- 3010547267
- 3014471045
- 3007675960
- 3021959198
- 3003857817
- 3014489639
- 3016969129
- 9616873
- 9615410
- 9618009
- 3006541027
- 3007608806
- 3004142507
- 3043105518
- 3008717361
- 3014522447
- 3005783142
- 3039359026
- 1058069
- 3012274425
- 3012425482
- 3006160539
- 3021071770
- 3043105164
- 3004141004
- 3015989577
- 3032587493
- 3009265647
- 3017959212
- 3005260401
- 2531465
- 3014266593
- 3012521614
- 2648727
- 8030931
- 3030226288
- 2937137
- 3044425292
- 3011191255
- 3005905321
- 3007309323
- 3008841035
- 3030927010
- 3003650116
- 3027344674
- 3010461764
- 3030671633
- 3034732597
- 3033848621
- 1220973
- 1821729
- 3022982004
- 3035111592
- 8043717
- 3019984611
- 9615350
- 3008370857
- 3022159079
- 3026585646
- 3033796886
- 3033860076
- 3005619729
- 3011707750
- 3003820676
- 3008597995
- 3017278503
- 3007963811
- 3004730072
Source Documents#
Other 510(k) Records For Product Code ITI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K254206 | Power wheelchair (ZS-EW8026) | Ningbo Zhishan Medical Technology Co., Ltd. | 2026-03-27 |