FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
INF 4160 PLUS, MODEL D-FJ31F
K Number: K092780
·
Decision Jan 7, 2010
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
72
Applicant Total
7
Review Days
119
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Basic Information
- Device Name
- INF 4160 PLUS, MODEL D-FJ31F
- K Number
- K092780
- 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
- September 10, 2009
- Decision Date
- January 7, 2010
- Product Code
- LIH
- 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 |
|---|---|---|---|
| LIH | Interferential Current Therapy | FDA class 2 | Neurology |
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Other Clearances by Fuji Dynamics Limited
| K Number | Device Name | ||
|---|---|---|---|
| K063642 | FD EMS, MODEL # D-FJ30E | Dec 13, 2007 | Substantially Equivalent |
| K052813 | FD TENS 2030, MODEL DFJ24T | Jan 25, 2006 | 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 |