FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
KYMCO EQ10D Scooter
K Number: K163201
·
Decision Mar 16, 2017
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
346
Applicant Total
7
Review Days
121
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Basic Information
- Device Name
- KYMCO EQ10D Scooter
- K Number
- K163201
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3800
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kwang Yang Motor Co., Ltd.
- Date Received
- November 15, 2016
- Decision Date
- March 16, 2017
- 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 |
Similar 510(k) Clearances
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Power Mobility Scooter (MJMA01, MJMA02)
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Other Clearances by Kwang Yang Motor Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K130940 | KYMCO EQ20C SCOOTER | Oct 7, 2013 | Substantially Equivalent |
| K082901 | KYMCO FORU, MODEL EQ20 | Oct 28, 2008 | Substantially Equivalent |
| K082900 | KYMCO FORU, MODEL EQ10 | Oct 28, 2008 | Substantially Equivalent |
| K081133 | KYMCO FORU, MODEL EQ40 | Jun 10, 2008 | Substantially Equivalent |
| K072630 | FORU, MODEL EQ30 | Oct 3, 2007 | Substantially Equivalent |
| K072027 | FORU KV10HB | Aug 20, 2007 | Substantially Equivalent |