FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYSTEM 70 AND 100
K Number: K904246
·
Decision Jun 10, 1991
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
580
Applicant Total
3
Review Days
269
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Basic Information
- Device Name
- SYSTEM 70 AND 100
- K Number
- K904246
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Folio Products, Inc.
- Date Received
- September 14, 1990
- Decision Date
- June 10, 1991
- Product Code
- ITI
- 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 |
|---|---|---|---|
| ITI | Wheelchair, Powered | FDA class 2 | Physical Medicine |
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