FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INFINITY ELECTROTHERAPY SYSTEM
K Number: K042057
·
Decision Dec 17, 2004
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
72
Applicant Total
60
Review Days
140
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Basic Information
- Device Name
- INFINITY ELECTROTHERAPY SYSTEM
- K Number
- K042057
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Empi
- Date Received
- July 30, 2004
- Decision Date
- December 17, 2004
- 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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