FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AQUATREX UNDERWATER TREADMILL SYSTEM
K Number: K895104
·
Decision Dec 4, 1989
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
42
Applicant Total
1
Review Days
111
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Basic Information
- Device Name
- AQUATREX UNDERWATER TREADMILL SYSTEM
- K Number
- K895104
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5380
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Edmonds Medical Systems
- Date Received
- August 15, 1989
- Decision Date
- December 4, 1989
- Product Code
- IOL
- 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 |
|---|---|---|---|
| IOL | Treadmill, Powered | FDA class 1 | Physical Medicine |
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