FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
Tua Face Fitness / Tua Trend Face
K Number: K192077
·
Decision Sep 30, 2020
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
65
Applicant Total
1
Review Days
425
Basic Information
- Device Name
- Tua Face Fitness / Tua Trend Face
- K Number
- K192077
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vupiesse S.R.L
- Date Received
- August 2, 2019
- Decision Date
- September 30, 2020
- 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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