FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TENS PREP
K Number: K893604
·
Decision Nov 21, 1989
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
68
Applicant Total
34
Review Days
189
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Basic Information
- Device Name
- TENS PREP
- K Number
- K893604
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1275
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Smith & Nephew United, Inc.
- Date Received
- May 16, 1989
- Decision Date
- November 21, 1989
- Product Code
- GYB
- 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 |
|---|---|---|---|
| GYB | Media, Electroconductive | FDA class 2 | Neurology |
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| K935803 | CICA-CARE SILICONE GEL SHEET | Feb 3, 1994 | Substantially Equivalent |
| K932263 | SOLOSITE DERMAL WOUND GEL | Oct 1, 1993 | Substantially Equivalent |
| K926508 | INTRASITE GEL | Jul 13, 1993 | Substantially Equivalent |
| K922897 | STRAPPAL | Sep 15, 1992 | Substantially Equivalent |