FDA 510(k)
Substantially Equivalent
🇺🇸 United States
TENS DEVICE
K Number: K813098
·
Decision Nov 20, 1981
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
14
Review Days
17
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Basic Information
- Device Name
- TENS DEVICE
- K Number
- K813098
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Staodynamics, Inc.
- Date Received
- November 3, 1981
- Decision Date
- November 20, 1981
- Advisory Committee
- Unknown
- Review Advisory Committee
- NE
- Third Party
- N
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 |
| K813283 | 10D (TENS DEVICE) | Feb 10, 1982 | 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 |