FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
10D (TENS DEVICE)
K Number: K813283
·
Decision Feb 10, 1982
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
14
Review Days
79
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Basic Information
- Device Name
- 10D (TENS DEVICE)
- K Number
- K813283
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Staodynamics, Inc.
- Date Received
- November 23, 1981
- Decision Date
- February 10, 1982
- Product Code
- GZJ
- 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 |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | FDA class 2 | Neurology |
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Other Clearances by Staodynamics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K852298 | TENS-AID STERILE ELECTRODES FOR POST-OP TENS | Jun 24, 1985 | Substantially Equivalent |
| K843964 | TENS-AID PREMIUM ELECTRODES | Feb 25, 1985 | Substantially Equivalent |
| K832988 | STAODYN EMS/PLUS | Nov 22, 1983 | Substantially Equivalent |
| K813098 | TENS DEVICE | Nov 20, 1981 | Substantially Equivalent |
| K811345 | INSIGHT | Jul 10, 1981 | Substantially Equivalent |
| K792529 | POINT LOCATOR STIMULATOR | Feb 26, 1980 | Substantially Equivalent |
| K792501 | PLS MINI | Feb 26, 1980 | Substantially Equivalent |
| K800068 | ELECTRICAL MUSCLE STIMULATOR (EMS) | Feb 5, 1980 | Substantially Equivalent |
| K792502 | TENS 4100 | Dec 18, 1979 | Substantially Equivalent |
| K792474 | TENS 4500 | Dec 13, 1979 | Substantially Equivalent |