FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TENS-EMS-14
K Number: K083030
·
Decision Feb 5, 2009
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
6
Review Days
118
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Basic Information
- Device Name
- TENS-EMS-14
- K Number
- K083030
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Emsi
- Date Received
- October 10, 2008
- Decision Date
- February 5, 2009
- Product Code
- GZJ
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- Y
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 Emsi
| K Number | Device Name | ||
|---|---|---|---|
| K140467 | FLEX-MT + | Oct 7, 2014 | Substantially Equivalent |
| K102202 | GS 3000 | Nov 23, 2010 | Substantially Equivalent |
| K090889 | EMSI GARMENT ELECTRODES | Dec 4, 2009 | Substantially Equivalent |
| K090717 | FLEX-TENS | May 8, 2009 | Substantially Equivalent |
| K071869 | TENS/IF 14 | Mar 7, 2008 | Substantially Equivalent |