510(k) K090805
- Device
- V10, THREE WHEEL SCOOTER, MODEL SC610V, V10, THREE WHEEL SCOOTER, MODEL SC610VPS, V10, FOUR WHEEL SCOOTER, MODEL SC710
- Applicant
- PRIDE MOBILITY PRODUCTS CORP.
- 510(k) number
- K090805
- Product code
- INI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-04-03
- Date received
- 2009-03-25
- Regulation
- 890.3800
- Classification name
- Vehicle, Motorized 3-wheeled
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- THOMAS J SCHAPPERT
- Address
- 182 Susquehanna Ave. Exeter PA US 18643 18643
FDA Registration Numbers#
- 3012604975
- 3033905189
- 8043717
- 3011191255
- 3007963811
- 2531618
- 3009265647
- 3013934051
- 3016969129
- 3035382637
- 3032013112
- 3012425482
- 3007608806
- 3015992762
- 3016733848
- 1528161
- 3012781455
- 3030822491
- 3015726735
- 3008597995
- 3004594214
- 3012538618
- 3030671633
- 3044470904
- 3012521614
- 1058069
- 3043105518
- 3017816603
- 9618009
- 9680333
- 3044425292
- 3005619729
- 9616873
- 3006541027
- 3008812160
- 3016068274
- 3042262539
- 3003882673
- 3008841035
- 3030226288
- 3034732597
- 3038949386
- 3039857114
- 3003636180
- 9616881
- 3007771912
- 3014489639
- 3019842343
- 8043457
- 3019984611
- 3022982004
- 1821729
- 3020147377
- 3020640553
- 3034989977
- 3016195086
- 3044918858
- 3022159079
- 3007675960
- 3033860076
- 3014983822
- 3026585646
- 3029926469
- 3008717361
- 3004142507
- 3006247243
- 3003820676
- 3037000105
- 3021071770
- 3004024088
- 3043153502
- 2531465
- 3017676057
- 3013973449
Source Documents#
Other 510(k) Records For Product Code INI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261078 | Electric Scooter (FNS01,FNS03) | Anhui Jbh Medical Apparatus Co., Ltd. | 2026-09-24 |
| K261859 | Electric Scooter (FDB08, FDB08A, FDB12) | Anhui JBH Medical Apparatus Co., Ltd. | 2026-09-19 |
| K260094 | Mobility Scooter (W3465, W3902 (S50 Carbon)) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2026-08-10 |
| K260176 | Mobility Scooter (W3483, W3483A) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2026-08-10 |
| K261232 | IERO Mobility Scooter (IERO-01) | Jochu Technology Co., Ltd. | 2026-07-14 |
| K261163 | Mobility Scooter (R200) | Yongkang Ruihe Metal Product Co., Ltd. | 2026-07-07 |
| K253257 | Virgo Mobility Scooter (Virgo-D,Virgo-F) | Jiangsu Intco Medical Products Co., Ltd. | 2026-06-08 |
| K253600 | Scooter (YD-03) | Yurob Rehabilitation Medical Co., Ltd. | 2026-06-03 |
| K260717 | Mobility Scooter (Air Carbon) | Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. | 2026-05-20 |
| 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 |
| K252275 | Electric Scooter (DDF100) | Zhejiang Nysin Medical Co., Ltd. | 2026-01-29 |
Legacy Summary#
summary
FDA Review#
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