FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
FD TENS 2090, FD TENS 2095
K Number: K152676
·
Decision Jan 22, 2016
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
5
Review Days
126
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Basic Information
- Device Name
- FD TENS 2090, FD TENS 2095
- K Number
- K152676
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fuji Dynamics , Ltd.
- Date Received
- September 18, 2015
- Decision Date
- January 22, 2016
- 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 Fuji Dynamics , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K161055 | Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 | Jul 12, 2016 | Substantially Equivalent |
| K152374 | LL TENS 160A, LL TENS 160B | Jan 13, 2016 | Substantially Equivalent |
| K111654 | FD TENS 2070 | Mar 1, 2012 | Substantially Equivalent |
| K111645 | FD TENS 2050 OR SLIDE TENS MODEL FD2050 | Nov 9, 2011 | Substantially Equivalent |