FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TREADMILL, DIAGNOSTIC
K Number: K760509
·
Decision Aug 30, 1976
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
42
Applicant Total
5
Review Days
6
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Basic Information
- Device Name
- TREADMILL, DIAGNOSTIC
- K Number
- K760509
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5380
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Medcraft Corp.
- Date Received
- August 24, 1976
- Decision Date
- August 30, 1976
- 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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Other Clearances by Medcraft Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K860467 | ELECTROSHOCK UNIT NEUROLOGY MODEL B-25 | Nov 10, 1986 | Substantially Equivalent |
| K791795 | COMP-ACT IV | Sep 27, 1979 | Substantially Equivalent |
| K760510 | MONITORING SYSTEM, REHABILITATION | Aug 30, 1976 | Substantially Equivalent |
| K760508 | ACCUTAPE 24 | Aug 30, 1976 | Substantially Equivalent |