FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Iontophoresis Electrodes
K Number: K232020
·
Decision Oct 16, 2023
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
72
Applicant Total
4
Review Days
101
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Basic Information
- Device Name
- Iontophoresis Electrodes
- K Number
- K232020
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5525
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Top-Rank Health Care Co., Ltd.
- Date Received
- July 7, 2023
- Decision Date
- October 16, 2023
- 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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