FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Sunny Plus (Sunny)
K Number: K251649
·
Decision Sep 18, 2025
Classifications
1
FEI Numbers
58
Registration Numbers
58
Same Product Code
77
Applicant Total
11
Review Days
112
Basic Information
- Device Name
- Sunny Plus (Sunny)
- K Number
- K251649
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ShenB Co., Ltd.
- Date Received
- May 29, 2025
- Decision Date
- September 18, 2025
- Product Code
- NFO
- 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 |
|---|---|---|---|
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | FDA class 2 | Neurology |
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