Palm NRG cellulite and muscle toning body device
FDA 510(k) K191940 · Heat IN A Click
510(k) numberK191940
Submission
- Device name
- Palm NRG cellulite and muscle toning body device
- Applicant
- Heat IN A Click
Homestead, FL, US - Received
- July 19, 2019
- Decision date
- November 3, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- PBX – Massager, Vacuum, Radio Frequency Induced Heat
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
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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More from Xod, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253279 | Feather/numiere 05 06 07 (05)OHS · Traditional | 12/24/2025SE |
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| K214015 | Palm NRG cellulite body device (model: Palm NRG body device)PBX · Traditional | 09/26/2022SE |
| K202055 | Looper (Model: ZX-579S)OLP · Traditional | 04/16/2021SE |
| K191938 | FitRelief TENS&EMS Wireless DeviceNGX · Traditional | 08/28/2020SE |
| K171821 | 2 Face / Face EvolutionNFO · Traditional | 04/26/2018SE |
| K150308 | Palm TENSNUH · Traditional | 10/20/2015SE |
Questions and answers
When was Palm NRG cellulite and muscle toning body device cleared by the FDA?
Palm NRG cellulite and muscle toning body device (K191940) received a 510(k) decision of Substantially Equivalent on November 3, 2020, 473 days after the submission was received.
What is the product code of K191940?
The FDA product code is PBX – Massager, Vacuum, Radio Frequency Induced Heat, a Class II (moderate risk) device regulated under 21 CFR 878.4400.