FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HUAYI K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4
K Number: K091482
·
Decision Jul 6, 2009
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
458
Applicant Total
3
Review Days
48
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Basic Information
- Device Name
- HUAYI K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4
- K Number
- K091482
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Danyang Huayi Medical Supply & Equipment Co, Ltd.
- Date Received
- May 19, 2009
- Decision Date
- July 6, 2009
- Product Code
- IOR
- 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 |
|---|---|---|---|
| IOR | Wheelchair, Mechanical | FDA class 1 | Physical Medicine |
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