Solax Electric Scooter
FDA 510(k) K192190 · Dongguan Prestige Sporting Goods Co., Ltd.
510(k) numberK192190
Submission
- Device name
- Solax Electric Scooter
- Applicant
- Dongguan Prestige Sporting Goods Co., Ltd.
Dongguan, CN - Received
- August 13, 2019
- Decision date
- April 23, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- INI – Vehicle, Motorized 3-Wheeled
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.3800
- Specialty
- Physical Medicine
Other 510(k)s with product code INI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260176 | Mobility Scooter (W3483, W3483A)INI · Traditional | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 08/10/2026SE |
| K260094 | Mobility Scooter (W3465, W3902 (S50 Carbon))INI · Traditional | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 08/10/2026SE |
| K261232 | IERO Mobility Scooter (IERO-01)INI · Traditional | Jochu Technology Co., Ltd. | 07/14/2026SE |
| K261163 | Mobility Scooter (R200)INI · Traditional | Yongkang Ruihe Metal Product Co., Ltd. | 07/07/2026SE |
| K253257 | Virgo Mobility Scooter (Virgo-D,Virgo-F)INI · Traditional | Jiangsu Intco Medical Products Co., Ltd. | 06/08/2026SE |
| K253600 | Scooter (YD-03)INI · Traditional | Yurob Rehabilitation Medical Co., Ltd. | 06/03/2026SE |
| K260717 | Mobility Scooter (Air Carbon)INI · Traditional | Suzhou Sweetrich Vehicle Industry Technology… | 05/20/2026SE |
| K260237 | Mobility Scooter (X-12, X-14, X-17)INI · Traditional | Wuyi Aichi Industry and Trade Co., Ltd. | 04/22/2026SE |
| K252813 | Electrical Scooter (SM4226)INI · Traditional | Lerado Zhongshan Peaceful Cove Business Trading… | 03/17/2026SE |
| K253936 | Power Mobility Scooter (MJMA01, MJMA02)INI · Traditional | Nanjing Mijo Technology Co., Ltd. | 03/12/2026SE |
More from Nanjing Mijo Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K190737 | Solax Electric Scooter (Models: S204311M, S204161, S204143)INI · Traditional | 05/10/2021SE |
| K200978 | Electric Wheelchair (Model: S7110)ITI · Traditional | 04/16/2021SE |
| K202632 | Electric wheelchair (S7204/S7205)ITI · Traditional | 04/08/2021SE |
| K201508 | Infrared ThermometerFLL · Traditional | 03/09/2021SE |
| K202549 | Solax Electric Scooter (Model: S202261B)INI · Traditional | 02/26/2021SE |
| K191897 | Solax Electric Scooter (Models: S3023, S3024, S3025, S3026)INI · Traditional | 02/10/2021SE |
| K200857 | Electric wheelchair (Model: S7012)ITI · Traditional | 12/17/2020SE |
| K182400 | Solax Powered Wheelchair (Models: S7101, S7103)ITI · Traditional | 04/14/2020SE |
| K182576 | Solax Powered WheelchairITI · Traditional | 05/21/2019SE |
| K172440 | Solax Electric Scooter, Models: S302121, S302131, S302141, S302151INI · Traditional | 07/13/2018SE |
Questions and answers
When was Solax Electric Scooter cleared by the FDA?
Solax Electric Scooter (K192190) received a 510(k) decision of Substantially Equivalent on April 23, 2021, 619 days after the submission was received.
What is the product code of K192190?
The FDA product code is INI – Vehicle, Motorized 3-Wheeled, a Class II (moderate risk) device regulated under 21 CFR 890.3800.