FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEMECTRODYN MODEL 2 & ENDOVAC 2
K Number: K854721
·
Decision Mar 6, 1986
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
72
Applicant Total
13
Review Days
104
Basic Information
- Device Name
- NEMECTRODYN MODEL 2 & ENDOVAC 2
- K Number
- K854721
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- NEMECTRON MEDICAL, INC.
- Date Received
- November 22, 1985
- Decision Date
- March 6, 1986
- Product Code
- LIH
- 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 |
|---|---|---|---|
| LIH | Interferential Current Therapy | FDA class 2 | Neurology |
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Other Clearances by NEMECTRON MEDICAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K923396 | THERMODYN | May 26, 1993 | Substantially Equivalent |
| K895000 | NEMECTRON MICROWAVE | Jul 27, 1990 | Substantially Equivalent |
| K862376 | NEMECTROSON MODEL 2 | Jul 23, 1986 | Substantially Equivalent |
| K854720 | NEMECTRODYN MODEL 2 & ENDOVAC 2 POWER MUSCLE STIM. | Mar 10, 1986 | Substantially Equivalent |
| K844416 | THERMOPULS E | Mar 12, 1985 | Substantially Equivalent |
| K843734 | NEMDI | Oct 25, 1984 | Substantially Equivalent |
| K843735 | SOFTEPIL | Oct 25, 1984 | Substantially Equivalent |
| K823511 | EMG BIOFEEDBACK DEVICE | Mar 31, 1983 | Substantially Equivalent |
| K820334 | NEMECTRODYN MODELS 8,7,5 (VOLS. I-IV | Mar 15, 1982 | Substantially Equivalent |
| K810513 | ELECTRODYN CII-INTERFERENTIAL MUSCLE | May 11, 1981 | Substantially Equivalent |