510(k) K214015
K214015 is an FDA 510(k) premarket notification submitted by Heat IN A Click, LLC for the device "Palm NRG cellulite body device (model: Palm NRG body device)". The FDA issued a decision of Substantially Equivalent on September 26, 2022. The device falls under product code PBX (Massager, Vacuum, Radio Frequency Induced Heat), a Class II device regulated under 21 CFR 878.4400. Heat IN A Click, LLC has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 26, 2022
- Date Received
- December 22, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Massager, Vacuum, Radio Frequency Induced Heat
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type
Generates heat in body tissues for minor relief of minor aches and pain. Mechanical massaging to provide a temporary reduction in the appearance of cellulite.