FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
INF 4160, MODEL D-FJ27F
K Number: K043407
·
Decision Feb 11, 2005
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
72
Applicant Total
7
Review Days
63
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- INF 4160, MODEL D-FJ27F
- K Number
- K043407
- 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
- December 10, 2004
- Decision Date
- February 11, 2005
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LIH), ordered by most recent decision date.
Vecttor VT-300
FDA 510(k)
FDA Class 2
·Neurology
ETD4000
FDA 510(k)
FDA Class 2
·Neurology
Avid IF2
FDA 510(k)
FDA Class 2
·Neurology
GEMORE TRUE SINE INTERFERENTIAL STIMULATOR
FDA 510(k)
FDA Class 2
·Neurology
VECTTOR VT-200
FDA 510(k)
FDA Class 2
·Neurology
EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908
FDA 510(k)
FDA Class 2
·Neurology
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 |
| K052813 | FD TENS 2030, MODEL DFJ24T | Jan 25, 2006 | 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 |