FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE
K Number: K954737
·
Decision Jul 3, 1996
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
171
Applicant Total
5
Review Days
261
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Basic Information
- Device Name
- SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE
- K Number
- K954737
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5050
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- J-Tech, Inc.
- Date Received
- October 16, 1995
- Decision Date
- July 3, 1996
- Product Code
- HCC
- Advisory Committee
- Neurology
- 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 |
|---|---|---|---|
| HCC | Device, Biofeedback | FDA class 2 | Neurology |
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Other Clearances by J-Tech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954647 | INCLINOMETER | Oct 30, 1995 | Substantially Equivalent |
| K945630 | LARGE MUSCLE STRENGTH GAUGE | May 10, 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 |