FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
APEX Manual Wheelchair
K Number: K161425
·
Decision Dec 5, 2016
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
458
Applicant Total
4
Review Days
196
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Basic Information
- Device Name
- APEX Manual Wheelchair
- K Number
- K161425
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Motion Composites
- Date Received
- May 23, 2016
- Decision Date
- December 5, 2016
- 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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