FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
AVANTICARE, MODEL SA4021
K Number: K060068
·
Decision Mar 8, 2006
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
346
Applicant Total
6
Review Days
58
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Basic Information
- Device Name
- AVANTICARE, MODEL SA4021
- K Number
- K060068
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3800
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lerado China Limited
- Date Received
- January 9, 2006
- Decision Date
- March 8, 2006
- 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 Lerado China Limited
| K Number | Device Name | ||
|---|---|---|---|
| K070802 | LERADOTECH, MODEL SC | Apr 13, 2007 | Substantially Equivalent |
| K070817 | LERADOTECH SCOOTER, MODEL SB | Apr 13, 2007 | Substantially Equivalent |
| K070433 | LERADO, POWER WHEELCHAIR, PB | Mar 16, 2007 | Substantially Equivalent |
| K051473 | LEARDO, AVANTICARE ELECTRICAL SCOOTERSM3021 | Aug 31, 2005 | Substantially Equivalent |
| K051538 | AVANTICARE, MODEL SA4022 | Jul 21, 2005 | Substantially Equivalent |