FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Mobility Scooter (YL-09B, YL-07)
K Number: K242139
·
Decision Jan 6, 2025
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
346
Applicant Total
2
Review Days
168
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Basic Information
- Device Name
- Mobility Scooter (YL-09B, YL-07)
- K Number
- K242139
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3800
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Yongkang Yile Vehicle Co., Ltd.
- Date Received
- July 22, 2024
- Decision Date
- January 6, 2025
- Product Code
- INI
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- NE
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (INI), ordered by most recent decision date.
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Power Mobility Scooter (MJMA01, MJMA02)
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Other Clearances by Yongkang Yile Vehicle Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K234098 | Mobility Scooter (C4+) | Apr 18, 2024 | Substantially Equivalent |