FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Palm NRG cellulite and muscle toning body device
K Number: K191940
·
Decision Nov 3, 2020
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
77
Applicant Total
2
Review Days
473
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Basic Information
- Device Name
- Palm NRG cellulite and muscle toning body device
- K Number
- K191940
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Heat IN A Click
- Date Received
- July 19, 2019
- Decision Date
- November 3, 2020
- Product Code
- PBX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Heat IN A Click
| K Number | Device Name | ||
|---|---|---|---|
| K171821 | 2 Face / Face Evolution | Apr 26, 2018 | Substantially Equivalent |