510(k) K214015

Palm NRG cellulite body device (model: Palm NRG body device) by Heat IN A Click, LLC — Product Code PBX

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.

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