FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LARGE MUSCLE STRENGTH GAUGE
K Number: K945630
·
Decision May 10, 1995
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
32
Applicant Total
5
Review Days
175
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Basic Information
- Device Name
- LARGE MUSCLE STRENGTH GAUGE
- K Number
- K945630
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.1500
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- J-Tech, Inc.
- Date Received
- November 16, 1994
- Decision Date
- May 10, 1995
- Product Code
- KQX
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| KQX | Goniometer, Ac-Powered | FDA class 1 | Orthopedic |
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Other Clearances by J-Tech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954737 | SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE | Jul 3, 1996 | Substantially Equivalent |
| K954647 | INCLINOMETER | Oct 30, 1995 | Substantially Equivalent |
| K913587 | JTECH 50 SERIES CUTTING LOOP | Oct 23, 1991 | Substantially Equivalent |
| K912526 | GS-220 HAND IMPAIRMENT EVALUATION SYSTEM | Sep 5, 1991 | Substantially Equivalent |