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FDA 510(k)

Palm NRG cellulite body device (model: Palm NRG body device)

K-Number: K214015 · 2022-09-26

Decision Date2022-09-26
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Palm NRG cellulite body device (model: Palm NRG body device) is the device name listed in this FDA 510(k) record. The listed applicant is Heat IN A Click, LLC. It received FDA 510(k) clearance on 2022-09-26 under 510(k) number K214015. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Palm NRG cellulite body device (model: Palm NRG body device)?

Palm NRG cellulite body device (model: Palm NRG body device) is a medical device that received FDA 510(k) clearance on 2022-09-26. The listed applicant is Heat IN A Click, LLC. The 510(k) number is K214015.

When did Palm NRG cellulite body device (model: Palm NRG body device) receive FDA 510(k) clearance?

Palm NRG cellulite body device (model: Palm NRG body device) received FDA 510(k) clearance on 2022-09-26, under 510(k) number K214015.

Who is the listed applicant for Palm NRG cellulite body device (model: Palm NRG body device)?

The FDA 510(k) record lists Heat IN A Click, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Palm NRG cellulite body device (model: Palm NRG body device)?

The FDA product code for Palm NRG cellulite body device (model: Palm NRG body device) is PBX.

Other records listing Heat IN A Click, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 7 devices →

Related Devices (Code: PBX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.