FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 AND SL 801 MECHANICAL WHEELCHAIRS
K Number: K020100
·
Decision Mar 8, 2002
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
458
Applicant Total
4
Review Days
56
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Basic Information
- Device Name
- SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 AND SL 801 MECHANICAL WHEELCHAIRS
- K Number
- K020100
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Regulatory Insight, Inc.
- Date Received
- January 11, 2002
- Decision Date
- March 8, 2002
- 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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Other Clearances by Regulatory Insight, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K140780 | KEGEL SMART, KEGELSMART PEARL | Sep 10, 2014 | Substantially Equivalent |
| K112505 | ETHEREA | Apr 6, 2012 | Substantially Equivalent |
| K020094 | EN 600-658, EN 600-666, EN 600-664, EN 600-690, EN 600-651, EN 600-663, EN 600-665 AND EN 600-670 MECHANICAL WHEELCHAIRS | Mar 8, 2002 | Substantially Equivalent |