FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
E.W.L. P-TENS MODEL(TENS
K Number: K813601
·
Decision Mar 19, 1982
Classifications
1
FEI Numbers
179
Registration Numbers
179
Same Product Code
601
Applicant Total
6
Review Days
81
Basic Information
- Device Name
- E.W.L. P-TENS MODEL(TENS
- K Number
- K813601
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- ELECTRONIC WAVEFORM LABORATORY, INC.
- Date Received
- December 28, 1981
- Decision Date
- March 19, 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 ELECTRONIC WAVEFORM LABORATORY, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K103738 | H-WAVE | Jun 1, 2011 | Substantially Equivalent |
| K081998 | H-WAVE SPORT | Jul 9, 2009 | Substantially Equivalent |
| K915230 | H WAVE MUSCLE STIMULATOR | May 8, 1992 | Substantially Equivalent |
| K873604 | E.W.L. P-TENS/H-WAVE FOR GENERAL DENTISTRY | Apr 12, 1988 | Substantially Equivalent |
| K862121 | E.W.L. P-TENS/H-WAVE | Jun 17, 1987 | Substantially Equivalent |