FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TENS-IT
K Number: K933368
·
Decision Jun 7, 1994
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
8
Review Days
333
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Basic Information
- Device Name
- TENS-IT
- K Number
- K933368
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Electro Med Supply, Inc.
- Date Received
- July 9, 1993
- Decision Date
- June 7, 1994
- 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 Electro Med Supply, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K872208 | MS-112, POWERED MUSCLE STIMULATOR | Oct 6, 1987 | Substantially Equivalent |
| K872206 | MD-104, POWERED MUSCLE STIMULATOR | Oct 6, 1987 | Substantially Equivalent |
| K872207 | MS-108, POWERED MUSCLE STIMULATOR | Oct 6, 1987 | Substantially Equivalent |
| K862487 | MS-139 ELECTRONIC MUSCLE STIMULATOR | Jul 16, 1986 | Substantially Equivalent for Some Indications |
| K862486 | MS-159 ELECTRONIC MUSCLE STIMULATOR | Jul 16, 1986 | Substantially Equivalent for Some Indications |
| K862485 | MS-179 ELECTRONIC MUSCLE STIMULATOR | Jul 16, 1986 | Substantially Equivalent for Some Indications |
| K854801 | MS-189 MUSCLE STIMULATOR | Mar 27, 1986 | Substantially Equivalent |