510(k) K241159
- Device
- Handbike Batec Electric
- Applicant
- Batec Mobility, S.L.
- 510(k) number
- K241159
- Product code
- ITI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-03-07
- Date received
- 2024-04-26
- 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
Related Records
Applicant Contact
- Contact
- Jordi Clapés Donadeu
- Address
- C/ Illa De Buda 2 Sant Quirze Del Vallès ES 08192 08192
FDA Registration Numbers
- 3004594214
- 3002667030
- 3003857817
- 3033848621
- 3003123807
- 3034732597
- 1821729
- 1531186
- 3001185828
- 3027135885
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- 3043105518
- 3014471045
- 3038503938
- 1220973
- 3027847712
- 3030927010
- 3019677893
- 2648727
- 3007728095
- 3035782854
- 3020155847
- 3008812160
- 3010461764
- 3003636180
- 3005260401
- 3012781455
- 3007608806
- 3003650116
- 3005619729
- 9680333
- 3004443928
- 3011969521
- 3020640553
- 8030931
- 3019842343
- 3043105164
- 3008370857
- 3035111592
- 3039857114
- 3014489639
- 3022982004
- 3015989577
- 3014810929
- 3008597995
- 3008717361
- 3011523631
- 2937137
- 3022159079
- 3030671633
- 9618009
- 3007771912
- 3011191255
- 3016969129
- 3019984611
- 3011962812
- 9616881
- 9615410
- 9616873
- 3021374638
- 3012538618
- 3004730072
- 2531465
- 2027797
- 3014273557
- 3007963811
- 9615350
- 3016195086
- 3004024088
- 3033905189
- 3012425482
- 3030410174
- 8043457
- 3012521614
- 3033860076
- 3007309323
- 3008466210
- 3015992762
- 3017959212
- 3030226288
- 3007675960
- 3004141004
- 3044470904
- 3017278503
- 3014653196
- 3038189190
- 3012274425
- 3013934051
- 1221084
- 3009265647
- 3005905321
- 3031595780
- 3005783142
- 3011749761
- 3043165991
- 3042501731
- 3010547267
- 3031588965
- 3027344674
- 3043711862
- 3014266593
- 8043717
- 3032171348
- 3032587493
- 3036988603
- 3006160539
- 3033796886
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- 3006541027
- 3003882673
- 3013025777
- 3021959198
- 3039359026
- 3035853002
- 3026585646
- 3004142507
- 3014983822
- 3032014158
- 3014522447
- 3008841035
- 1058069
- 3021071770
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08436557350312 | Batec | BATEC MOBILITY SL. | 2025-04-02 |
| 08436557350633 | Batec | BATEC MOBILITY SL. | 2025-04-02 |
| 08436557350626 | Batec | BATEC MOBILITY SL. | 2025-04-02 |
| 08436557350619 | Batec | BATEC MOBILITY SL. | 2025-04-02 |
| 08436557350602 | Batec | BATEC MOBILITY SL. | 2025-04-02 |
| 08436557350596 | Batec | BATEC MOBILITY SL. | 2025-04-02 |
| 08436557350589 | Batec | BATEC MOBILITY SL. | 2025-04-02 |
| 08436557350572 | Batec | BATEC MOBILITY SL. | 2025-04-02 |
| 08436557350411 | Batec | BATEC MOBILITY SL. | 2025-04-02 |
| 08436557350404 | Batec | BATEC MOBILITY SL. | 2025-04-02 |
| 08436557350398 | Batec | BATEC MOBILITY SL. | 2025-04-02 |
| 08436557350381 | Batec | BATEC MOBILITY SL. | 2025-04-02 |
| 08436557350640 | Batec | BATEC MOBILITY SL. | 2025-04-02 |
| 08436557350305 | Batec | BATEC MOBILITY SL. | 2025-04-02 |
| 08436557350299 | Batec | BATEC MOBILITY SL. | 2025-04-02 |
| 08436557350282 | Batec | BATEC MOBILITY SL. | 2025-04-02 |
| 08436557350237 | Batec | BATEC MOBILITY SL. | 2025-04-02 |
| 08436557350220 | Batec | BATEC MOBILITY SL. | 2025-04-02 |
| 08436557350213 | Batec | BATEC MOBILITY SL. | 2025-04-02 |
| 08436557350206 | Batec | BATEC MOBILITY SL. | 2025-04-02 |
| 08436557350190 | Batec | BATEC MOBILITY SL. | 2025-04-02 |
| 08436557350183 | Batec | BATEC MOBILITY SL. | 2025-04-02 |
| 08436557350176 | Batec | BATEC MOBILITY SL. | 2025-04-02 |
| 08436557350169 | Batec | BATEC MOBILITY SL. | 2025-04-02 |
| 08436557350824 | Batec | BATEC MOBILITY SL. | 2025-04-02 |
| 08436557350978 | Batec | BATEC MOBILITY SL. | 2025-04-02 |
| 08436557350961 | Batec | BATEC MOBILITY SL. | 2025-04-02 |
| 08436557350954 | Batec | BATEC MOBILITY SL. | 2025-04-02 |
| 08436557350947 | Batec | BATEC MOBILITY SL. | 2025-04-02 |
| 08436557350930 | Batec | BATEC MOBILITY SL. | 2025-04-02 |
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 |