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510(k) Data Aggregation
K Number
K214015Device Name
Palm NRG cellulite body device (model: Palm NRG body device)
Manufacturer
Heat In A Click LLC.
Date Cleared
2022-09-26
(278 days)
Product Code
PBX, GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Heat In A Click LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Palm NRG cellulite body device (model: Palm NRG body device) is intended for delivering non thermal RF combined with massage for temporary reduction in the appearance of cellulite.
Device Description
Palm NRG cellulite body device (model: Palm NRG body device) is a portable, non-invasive, at home skin care device. It works for with radio frequency (RF) to help users to enjoy the care skin. The device is a noninvasive, non-ablative device and it is supplied as non-sterile, it has 2 buttons, one for power on/off, the other one for level adjust. The main unit is equipped with accessories of an adapter and a charging base. The charging base is used to connect the adapter and the main unit.
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K Number
K202055Device Name
Looper (Model: ZX-579S)
Manufacturer
Heat In A Click LLC
Date Cleared
2021-04-16
(266 days)
Product Code
OLP, OHS
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Heat In A Click LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Looper (Model: ZX-579S) is a hand-held device for over-the counter aesthetic purposes. The Photon mode red light is indicated for the use in treating wrinkles on the blue light is indicated for the treatment of the mild to moderate inflammatory acne.
Device Description
Looper (Model: ZX-579S) is a hand-held device for over-the-counter aesthetic purposes, it's a multifunctional comprehensive beauty instrument. It's combined with the two kinds of operation functions: SONIC and PHOTON mode.
Sonic mode: The Sonic waves can provide vibrating to facial skin. The device provides 5 vibration intensities for users to choose from.
Photon mode: The red light is intended for use in treating wrinkles on the face, and the blue light is intended for the treatment of the mild to moderate inflammatory acne. It emits energy in the red spectrum for the treatment of facial wrinkles. The therapeutic probe is designed for direct contact with the face for treatment.
The Looper device consists of an applicator and charging base. An applicator is a hand-held unit used for treatment. The treatment surface is located at the applicator tip and comes in direct contact with the skin. The charging base charging for the applicator. And there is no external data connection capability (e.g., through USB, Ethernet, WiFi, Bluetooth, etc.) for the device.
There are two keys: the PHOTON key and the SONIC key. The PHOTON is to select red light and the Sonic is to select the SONIC mode and adjust the sonic. Both keys can turn on/off the device.
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K Number
K191938Device Name
FitRelief TENS&EMS Wireless Device
Manufacturer
Heat In A Click LLC.
Date Cleared
2020-08-28
(406 days)
Product Code
NGX, NUH
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
Heat In A Click LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Not Found
Device Description
Not Found
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K Number
K150308Device Name
Palm TENS
Manufacturer
HEAT IN A CLICK LLC
Date Cleared
2015-10-20
(253 days)
Product Code
NUH
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
HEAT IN A CLICK LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Palm TENS is intended to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
Device Description
Not Found
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