FDA 510(k)
FDA class 2
Substantially Equivalent
🇭🇰 Hong Kong
FD TENS 2030, MODEL DFJ24T
K Number: K052813
·
Decision Jan 25, 2006
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
7
Review Days
113
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Basic Information
- Device Name
- FD TENS 2030, MODEL DFJ24T
- K Number
- K052813
- 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 Limited
- Date Received
- October 4, 2005
- Decision Date
- January 25, 2006
- 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 Limited
| K Number | Device Name | ||
|---|---|---|---|
| K092780 | INF 4160 PLUS, MODEL D-FJ31F | Jan 7, 2010 | Substantially Equivalent |
| K063642 | FD EMS, MODEL # D-FJ30E | Dec 13, 2007 | Substantially Equivalent |
| K043407 | INF 4160, MODEL D-FJ27F | Feb 11, 2005 | Substantially Equivalent |
| K041164 | L-TENS | May 20, 2004 | Substantially Equivalent |
| K994265 | MEDISANA DIGITAL TENS | Jul 6, 2000 | Substantially Equivalent |
| K994266 | FDTENS 2010 | Jul 6, 2000 | Substantially Equivalent |