FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRANSCUTANEOUS ELECTRONIC NERVE STIMULATOR
K Number: K896825
·
Decision Nov 16, 1990
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
20
Review Days
346
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Basic Information
- Device Name
- TRANSCUTANEOUS ELECTRONIC NERVE STIMULATOR
- K Number
- K896825
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Infrasonics Corp.
- Date Received
- December 5, 1989
- Decision Date
- November 16, 1990
- 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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| K923704 | INFANT STAR SERIES 500 | Oct 22, 1992 | Substantially Equivalent |
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| K913972 | STAR SYNC, MODIFICATION | Jan 9, 1992 | Substantially Equivalent |
| K905272 | ADULT STAR, MODIFICATION | Jan 30, 1991 | Substantially Equivalent |