FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACTIVAPATCH ET IONTOPHORESIS PATCH
K Number: K132832
·
Decision Feb 13, 2014
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
72
Applicant Total
3
Review Days
156
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Basic Information
- Device Name
- ACTIVAPATCH ET IONTOPHORESIS PATCH
- K Number
- K132832
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5525
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Activatek, Inc.
- Date Received
- September 10, 2013
- Decision Date
- February 13, 2014
- 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 |
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