FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEMECTRODYN 8
K Number: K802804
·
Decision Mar 16, 1981
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
547
Applicant Total
13
Review Days
131
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Basic Information
- Device Name
- NEMECTRODYN 8
- K Number
- K802804
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Nemectron Medical, Inc.
- Date Received
- November 5, 1980
- Decision Date
- March 16, 1981
- Product Code
- IPF
- 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 |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | FDA class 2 | Physical Medicine |
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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 |
| K854721 | NEMECTRODYN MODEL 2 & ENDOVAC 2 | Mar 6, 1986 | Substantially Equivalent |
| K844416 | THERMOPULS E | Mar 12, 1985 | Substantially Equivalent |
| K843735 | SOFTEPIL | Oct 25, 1984 | Substantially Equivalent |
| K843734 | NEMDI | 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 |