FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Solax Electric Scooter (Models: S204311M, S204161, S204143)
K Number: K190737
·
Decision May 10, 2021
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
346
Applicant Total
11
Review Days
780
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Basic Information
- Device Name
- Solax Electric Scooter (Models: S204311M, S204161, S204143)
- K Number
- K190737
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3800
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dongguan Prestige Sporting Goods Co., Ltd.
- Date Received
- March 22, 2019
- Decision Date
- May 10, 2021
- Product Code
- INI
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| INI | Vehicle, Motorized 3-Wheeled | FDA class 2 | Physical Medicine |
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Other Clearances by Dongguan Prestige Sporting Goods Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K192190 | Solax Electric Scooter | Apr 23, 2021 | Substantially Equivalent |
| K200978 | Electric Wheelchair (Model: S7110) | Apr 16, 2021 | Substantially Equivalent |
| K202632 | Electric wheelchair (S7204/S7205) | Apr 8, 2021 | Substantially Equivalent |
| K201508 | Infrared Thermometer | Mar 9, 2021 | Substantially Equivalent |
| K202549 | Solax Electric Scooter (Model: S202261B) | Feb 26, 2021 | Substantially Equivalent |
| K191897 | Solax Electric Scooter (Models: S3023, S3024, S3025, S3026) | Feb 10, 2021 | Substantially Equivalent |
| K200857 | Electric wheelchair (Model: S7012) | Dec 17, 2020 | Substantially Equivalent |
| K182400 | Solax Powered Wheelchair (Models: S7101, S7103) | Apr 14, 2020 | Substantially Equivalent |
| K182576 | Solax Powered Wheelchair | May 21, 2019 | Substantially Equivalent |
| K131302 | SOLAX | Nov 26, 2013 | Substantially Equivalent |