FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EMG BIOFEEDBACK DEVICE
K Number: K823511
·
Decision Mar 31, 1983
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
171
Applicant Total
13
Review Days
122
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Basic Information
- Device Name
- EMG BIOFEEDBACK DEVICE
- K Number
- K823511
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5050
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Nemectron Medical, Inc.
- Date Received
- November 29, 1982
- Decision Date
- March 31, 1983
- 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 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 |
| K820334 | NEMECTRODYN MODELS 8,7,5 (VOLS. I-IV | Mar 15, 1982 | Substantially Equivalent |
| K810513 | ELECTRODYN CII-INTERFERENTIAL MUSCLE | May 11, 1981 | Substantially Equivalent |