FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THERAPY SCOOTER
K Number: K780296
·
Decision Feb 24, 1978
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
4
Applicant Total
1
Review Days
3
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Basic Information
- Device Name
- THERAPY SCOOTER
- K Number
- K780296
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5370
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Convaid Product Development
- Date Received
- February 21, 1978
- Decision Date
- February 24, 1978
- Product Code
- KNL
- 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 |
|---|---|---|---|
| KNL | Board, Scooter, Prone | FDA class 1 | Physical Medicine |
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