FDA 510(k)
FDA class 2
Substantially Equivalent
🇿🇦 South Africa
STIMPOD NMS460 Nerve Stimulator
K Number: K161091
·
Decision Jan 18, 2017
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
7
Review Days
275
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Basic Information
- Device Name
- STIMPOD NMS460 Nerve Stimulator
- K Number
- K161091
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Xavant Technology (Pty), Ltd.
- Date Received
- April 18, 2016
- Decision Date
- January 18, 2017
- 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 Xavant Technology (Pty), Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K213049 | STIMPOD NMS450 Nerve Stimulator | Oct 16, 2022 | Substantially Equivalent |
| K140853 | STIMPOD ST2-3010 NERVE STIMULATOR | Nov 6, 2014 | Substantially Equivalent |
| K110118 | STIMTRODE SINGLE USE NERVE STIMULATOR | Feb 17, 2011 | Substantially Equivalent |
| K102084 | STIMPOD NMS450 NERVE STIMULATOR | Dec 16, 2010 | Substantially Equivalent |
| K093591 | STIMPOD MODEL NMS-400 NERVE STIMULATOR | Dec 3, 2009 | Substantially Equivalent |
| K072092 | XPOD/XMAP NERVE STIMULATOR | Nov 15, 2007 | Substantially Equivalent |