510(k) K251638
- Device
- Mobility Scooter (MS160C)
- Applicant
- Suzhou Master Machinery Manufacturing Co.,Ltd
- 510(k) number
- K251638
- Product code
- INI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-07-22
- Date received
- 2025-05-29
- Regulation
- 890.3800
- Classification name
- Vehicle, Motorized 3-Wheeled
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Siqi Shangguan
- Address
- 2/F, Block B, # 379, Delan Industrial Park, Zhangpu Town Kunshan CN 215321 215321
FDA Registration Numbers
- 9680333
- 3020640553
- 3004594214
- 3019842343
- 2531618
- 9616873
- 3016733848
- 1528161
- 3012538618
- 3039857114
- 3014489639
- 2531465
- 3022982004
- 3016068274
- 3020147377
- 3008597995
- 3042262539
- 1821729
- 3034732597
- 3007963811
- 3008717361
- 3006247243
- 3016195086
- 3004024088
- 3033905189
- 3012425482
- 3035382637
- 8043717
- 3032013112
- 3003820676
- 3037000105
- 8043457
- 3012521614
- 3033860076
- 3030671633
- 3043105518
- 3015992762
- 3017816603
- 3012604975
- 3015726735
- 9618009
- 3007771912
- 3029926469
- 3007675960
- 3006541027
- 3044470904
- 3003882673
- 3011191255
- 3008812160
- 3043153502
- 3003636180
- 3016969129
- 3012781455
- 3034989977
- 3013934051
- 3004142507
- 3026585646
- 3019984611
- 3014983822
- 3008841035
- 3007608806
- 3013973449
- 3009265647
- 1058069
- 3017676057
- 9616881
- 3021071770
- 3005619729
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810178883189 | Vive Mobility | VIVE HEALTH LLC | 2025-09-25 |
Other 510(k) Records For Product Code INI
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260237 | Mobility Scooter (X-12, X-14, X-17) | Wuyi Aichi Industry and Trade Co., Ltd. | 2026-04-22 |
| K252813 | Electrical Scooter (SM4226) | Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd. | 2026-03-17 |
| K253936 | Power Mobility Scooter (MJMA01, MJMA02) | Nanjing Mijo Technology Co., Ltd. | 2026-03-12 |
| K253631 | Mobility Scooter (CL-Q3, CL-Q4) | Zhejiang Wei Ling New Energy Technology Co., Ltd. | 2026-02-23 |
| K253643 | Mobility Scooter (S3) | Shenzhen Zhimahuaerkai Technology Co., Ltd. | 2026-02-18 |
| K252349 | Electric Scooter (Mojo-T330) | Dongguan Smarfody Mobility Technology Co., Ltd. | 2026-01-29 |
| K252347 | Electric Scooter (Mojo-T580) | Dongguan Smarfody Mobility Technology Co., Ltd. | 2026-01-29 |
| K252275 | Electric Scooter (DDF100) | Zhejiang Nysin Medical Co., Ltd. | 2026-01-29 |
| K253075 | Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0) | Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. | 2026-01-09 |
| K252817 | Mobility Scooter (BC-MS310) | Ningbo Baichen Medical Devices Co., Ltd. | 2026-01-02 |
| K252835 | Electric Scooter (S202572J, S2060, M2089, S2050) | Guangdong Prestige Technology Co., Ltd. | 2025-12-23 |
| K252588 | Mobility Scooter (T5) | Zhejiang Taotao Vehicle Co., Ltd. | 2025-12-04 |
| K252590 | Powered Mobility Scooter (PMS105, GUT177, GCAT047) | Intradin (Shanghai) Machinery Co., Ltd. | 2025-11-21 |
| K252502 | Folding Mobility Scooter (KD101) | Nanjing Kangni Smart Technology Co., Ltd. | 2025-10-06 |
| K251799 | Mobility Scooter (BBR-Q40-01); Mobility Scooter (BBR-Q40-02); Mobility Scooter (BBR-Q40-03); Mobility Scooter (BBR-Q40-04); Mobility Scooter (BBR-Q40-05); Mobility Scooter (BBR-Q40-06) | Jiangsu Bangbang Intelligent Technology Co., Ltd. | 2025-09-30 |