FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COMFORT/IO IONTOPHORESIS ELECTRODES
K Number: K060579
·
Decision Apr 20, 2006
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
72
Applicant Total
3
Review Days
45
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
- COMFORT/IO IONTOPHORESIS ELECTRODES
- K Number
- K060579
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 890.5525
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pepin Mfg., Inc.
- Date Received
- March 6, 2006
- Decision Date
- April 20, 2006
- Product Code
- EGJ
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| EGJ | Device, Iontophoresis, Other Uses | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EGJ), ordered by most recent decision date.
STOPWET iontophoresis apparatus (SW01)
FDA 510(k)
FDA Class 2
·Physical Medicine
Hidroxa SE30
FDA 510(k)
FDA Class 2
·Physical Medicine
Iontophoresis Electrodes
FDA 510(k)
FDA Class 2
·Physical Medicine
Dermadry
FDA 510(k)
FDA Class 2
·Physical Medicine
Saalio
FDA 510(k)
FDA Class 2
·Physical Medicine
Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE
FDA 510(k)
FDA Class 2
·Physical Medicine