FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HANDI-TRAK WHEELCHAIR SNOW CHAINS
K Number: K904913
·
Decision Nov 7, 1990
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
63
Applicant Total
2
Review Days
7
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Basic Information
- Device Name
- HANDI-TRAK WHEELCHAIR SNOW CHAINS
- K Number
- K904913
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3920
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Handi-Trak, Inc.
- Date Received
- October 31, 1990
- Decision Date
- November 7, 1990
- Product Code
- KNN
- 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 |
|---|---|---|---|
| KNN | Components, Wheelchair | FDA class 1 | Physical Medicine |
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Other Clearances by Handi-Trak, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K904862 | HANDI-TRACTION | Nov 5, 1990 | Substantially Equivalent |