FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THERMODYN
K Number: K923396
·
Decision May 26, 1993
Classifications
1
FEI Numbers
259
Registration Numbers
259
Same Product Code
41
Applicant Total
13
Review Days
320
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Basic Information
- Device Name
- THERMODYN
- K Number
- K923396
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5740
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Nemectron Medical, Inc.
- Date Received
- July 10, 1992
- Decision Date
- May 26, 1993
- Product Code
- IRT
- 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 |
|---|---|---|---|
| IRT | Pad, Heating, Powered | FDA class 2 | Physical Medicine |
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Other Clearances by Nemectron Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K810513 | ELECTRODYN CII-INTERFERENTIAL MUSCLE | May 11, 1981 | Substantially Equivalent |