(278 days)
Not Found
No
The summary describes a simple device with basic controls (on/off, level adjust) and mentions standard electrical safety and software validation, but there is no indication of AI/ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
This device is intended for temporary reduction in the appearance of cellulite, which is considered an aesthetic rather than a therapeutic purpose. It is also described as an "at home skin care device".
No
Explanation: The device is described as being "intended for delivering non thermal RF combined with massage for temporary reduction in the appearance of cellulite," which is a cosmetic/therapeutic function, not a diagnostic one. There is no mention of it being used to detect, diagnose, or monitor a medical condition.
No
The device description explicitly states it is a portable, non-invasive, at home skin care device with physical components like buttons, an adapter, and a charging base, indicating it is a hardware device with embedded software, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Palm NRG cellulite body device is a non-invasive device that applies RF and massage directly to the skin on the body. It does not involve the collection or analysis of any biological specimens.
- Intended Use: The intended use is for the "temporary reduction in the appearance of cellulite," which is a cosmetic or aesthetic purpose, not a diagnostic one.
The information provided clearly describes a device for external application to the body for a cosmetic purpose, which is fundamentally different from the function of an IVD.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
PBX, GEI
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.
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Areas of the body other than the face and injured areas
Indicated Patient Age Range
Adult people who desire to improve their body appearance
Intended User / Care Setting
Home Use, self-operation by an untrained user.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility:
Palm NRG cellulite body device (model: Palm NRG body device) has been evaluated the safety and performance by lab bench testing as following:
- Electrical safety test according to IEC 60601-1, IEC 60601-1-11 and IEC 60601-2-57 standards
- Electromagnetic compatibility test according to IEC 60601-1-2 standard
- Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
- Usability test according to guidance "Applying Human Factors and Usability Engineering to Medical Devices".
- Software verification and validation test according to the requirements of the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Heat In A Click LLC. % Cassie Lee Official Correspondent Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou, Guangdong 510000 China
Re: K214015
Trade/Device Name: Palm NRG cellulite body device (model: Palm NRG body device) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: PBX Dated: August 24, 2022 Received: August 25, 2022
Dear Cassie Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) Applying
Device Name
Palm NRG cellulite body device (model: Palm NRG body device)
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Sponsor: Heat In A Click LLC
510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Date of the summary updated: 2022-09-24
2. Submitter's Information
510(k) Owner's Name: Heat In A Click LLC Establishment Registration Number: 3008929787 Address: 1975 Tigertail Blvd Dania FL 33034 USA Tel: 1(954)518-9777 Fax: 1(954)320-7984 Contact Person: Guy Levi (CEO) Email: palmnrg@gmail.com
Application Correspondent:
Contact Person: Cassie Lee
Guangzhou GLOMED Biological Technology Co., Ltd.
Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China
Tel: +86 20 8266 2446
Email: requlatory@glomed-info.com
3. Subject Device Information
Classification Name: Electrosurgical Cutting and Coagulation Device and Accessories Trade Name: Palm NRG cellulite body device Model Name: Palm NRG body device Review Panel: General and Plastic Surgery Product Code: PBX, GEI Regulation Number: 21 CFR 878.4400
Heat In A Click LLC.
4
510(k) Number: K214015 Sponsor: Heat In A Click LLC
Regulatory Class: II
4.Predicate Device Information
Predicate Device 1:
Sponsor: Heat In A Click LLC Trade Name: Palm NRG cellulite body device Classification Name: Electrosurgical Cutting and Coagulation Device and Accessories 510(K) Number: K191940 Review Panel: General and Plastic Surgery Product Code: PBX, GEI Regulation Number: 21 CFR 878.4400 Regulation Class: II
Predicate Device 2:
Sponsor: El Global Trade Ltd.
Trade Name: sensiFirm
Classification Name: Electrosurgical Cutting and Coagulation Device and Accessories
510(K) Number: K170637
Review Panel: General and Plastic Surgery
Product Code: PBX, GEI
Regulation Number: 21 CFR 878.4400
Regulation Class: II
5.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.
5
510(k) Number: K214015 Sponsor: Heat In A Click LLC
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.
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.
6. Intended Use / Indications for 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.
7. Test Summary
7.1 Non-Clinical Tests Performed
Non-Clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility:
Palm NRG cellulite body device (model: Palm NRG body device) has been evaluated the safety and performance by lab bench testing as following:
- � Electrical safety test according to IEC 60601-1, IEC 60601-1-11 and IEC 60601-2-57 standards
- � Electromagnetic compatibility test according to IEC 60601-1-2 standard
- � Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
- � Usability test according to guidance "Applying Human Factors and Usability Engineering to Medical Devices".
- � Software verification and validation test according to the requirements of the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
7.2 Discussion of Clinical Tests Performed
There no Clinical Tests.
8. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, mode of operation, and intended use of Palm NRG cellulite body device (model: Palm NRG body device) substantially equivalent to the predicate devices quoted above.
6
Heat In A Click LLC Sponsor:
The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| Elements of
| Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Verdict |
|---|---|---|---|---|
| Company | Heat In A Click LLC | Heat In A Click LLC | El Global Trade Ltd. | -- |
| Classification | ||||
| Name | Electrosurgical Cutting | |||
| and Coagulation | ||||
| Device and | ||||
| Accessories | Electrosurgical | |||
| Cutting and | ||||
| Coagulation Device | ||||
| and Accessories | Electrosurgical Cutting | |||
| and Coagulation Device | ||||
| and Accessories | Same | |||
| 510(k) Number | Applying | K191940 | K170637 | -- |
| Product Code | PBX, GEI | PBX, GEI | PBX, GEI | Same |
| Intended Use / | ||||
| Indications for | ||||
| 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. | 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. | The sensiFirm device is | |||
| intended for delivering | ||||
| non thermal RF | ||||
| combined with massage | ||||
| for temporary reduction | ||||
| in the appearance of | ||||
| cellulite. | Same | |||
| Regulation | ||||
| Number | 878.4400 | 878.4400 | 878.4400 | Same |
| Regulatory | ||||
| Class | Class II | Class II | Class II | Same |
| Treatment areas | Areas of the body | |||
| other than the face | ||||
| and injured areas | Areas of the body | |||
| other than the face | ||||
| and injured areas | Cellulite areas (buttocks, | |||
| thigh, upper legs) | Same | |||
| Intended | ||||
| population | Adult people who | |||
| desire to improve their | ||||
| body appearance | Adult people who | |||
| desire to improve | ||||
| their body | ||||
| appearance | Adult people who desire | |||
| to improve their body | ||||
| appearance | Same | |||
| Use | ||||
| environment | Home Use, self- | |||
| operation | ||||
| by an untrained user. | Home Use, self- | |||
| operation | ||||
| by an untrained user. | Home Use, self- | |||
| operation | ||||
| by an untrained user. | Same | |||
| Elements of | ||||
| Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Verdict |
| Power Source(s) | Adapter:100-240Vac, | |||
| 50/60Hz | Adapter:100-240Vac, | |||
| 50/60Hz | 100-240 Vac, 50-60 Hz | Same | ||
| Software/Firmwa | ||||
| re/Microprocess | ||||
| or Control | Yes | Yes | Yes | Same |
| Automatic Shut | ||||
| Off | Yes | Yes | Yes | Same |
| On/Off Status | Yes | Yes | Yes | Same |
| Low Battery | Yes | Yes | Yes | Same |
| Weight | 0.6kg | 0.6kg | 192 gr/ 0.42 lb | Same |
| Dimensions of | ||||
| device(inch) | Device size:223 x | |||
| 155.5 x 59mm | ||||
| Base size:160.6 x 52.3 | ||||
| x 27.1mm | Device size:223 x | |||
| 155.5 x 59mm | ||||
| Base size:160.6 x | ||||
| 52.3 x 27.1mm | Hand piece:146 X 74 X | |||
| 63 mm3/ 5.72.92.5 | ||||
| inch | Same | |||
| Device main | ||||
| components | Power adaptor, hand- | |||
| held handpiece | Power adaptor, | |||
| hand-held handpiece | Power adaptor, hand- | |||
| held handpiece | Same | |||
| Mode of | ||||
| operation | Mechanical (vibration) | |||
| massage combined | ||||
| with RF energy | ||||
| emitted from Bi-polar | ||||
| electrodes via a | ||||
| delivery Handpiece | Mechanical | |||
| (vibration) massage | ||||
| combined with RF | ||||
| energy emitted from | ||||
| Bi-polar electrodes | ||||
| via a delivery | ||||
| Handpiece | Mechanical (vibration) | |||
| massage combined with RF | ||||
| energy emitted from | ||||
| Bi-polar electrodes via a | ||||
| delivery Handpiece | Same | |||
| Number of | ||||
| electrodes | 1 | 1 | 4 electrodes (2 pairs) | Same |
| Massage | Vibrational massage | |||
| (1000 rpm, 1.5 [g]) | ||||
| assisted by manual | ||||
| manipulation | Vibrational massage | |||
| (1000 rpm, 1.5 [g]) | ||||
| assisted by manual | ||||
| manipulation | Vibrational massage | |||
| (1000 rpm, 1.5 [g]) | ||||
| assisted by manual | ||||
| manipulation | Same | |||
| Energy Source | RF (Bi-polar), 1 MHz | RF (Bi-polar), 1 MHz | RF (Bi-polar), 1 MHz | Same |
| Electrodes | ||||
| treatment area | ||||
| [mm2] | 26cm²±5% | 26cm²±5% | ~2000 (calculated | |
| according to: 2x33x30), | ||||
| where - | ||||
| 2 – numbers of | Same | |||
| Elements of | ||||
| Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Verdict |
| electrodes pairs | ||||
| • 33 - average distance | ||||
| between electrodes is | ||||
| 33 mm | ||||
| • electrodes length 30 | ||||
| mm | ||||
| Treatment | ||||
| regimen | Perform the treatment | |||
| for 5-7 minutes on | ||||
| each area. 1 time per | ||||
| week, for 8 weeks. | Perform the | |||
| treatment for 5~7 | ||||
| minutes on each | ||||
| area. 1 time per | ||||
| week, for 8 weeks. | 20 minutes per each | |||
| area, 1 time per week, | ||||
| for 8 weeks | Same | |||
| Energy levels | ||||
| (maximal and | ||||
| user selectable) | Up to $10\pm1$ Watt | |||
| 6 to $10\pm1$ Watt (energy | ||||
| levels 1-5). | Up to $10\pm1$ Watt | |||
| 6 to $10\pm1$ Watt | ||||
| (energy levels 1-5). | Up to 10 Watts. 3 | |||
| energy levels(software | ||||
| and hardware limited):6, | ||||
| 8 or 10 Watts, | ||||
| depending on the user | ||||
| selection. | Same | |||
| Safety | ||||
| mechanism | Integrated IR | |||
| thermometer, with | ||||
| maximal temperature | ||||
| (skin surface 41 °C/ | ||||
| 105.8°F) | Integrated IR | |||
| thermometer, with | ||||
| maximal temperature | ||||
| (skin surface 41 °C/ | ||||
| 105.8°F) | Integrated IR | |||
| thermometer, with | ||||
| maximal temperature | ||||
| (skin surface 41 °C/ | ||||
| 105.8°F) | Same | |||
| Compliance with | ||||
| Voluntary | ||||
| Standards | AAMI/ES60601- | |||
| 1:2005/(R)2012 And | ||||
| A1:2012: | ||||
| IEC60601-1-2 | ||||
| IEC60601-1-6 | ||||
| IEC60601-1-11 | ||||
| IEC 60601-2-57 | AAMI/ES60601- | |||
| 1:2005/(R)2012 And | ||||
| A1:2012: | ||||
| IEC60601-1-2 | ||||
| IEC60601-1-6 | ||||
| IEC60601-1-11 | ||||
| IEC 60601-2-57 | IEC60601- | |||
| 1:2012/EN60601-1:2013 | ||||
| IEC 60601-1-2: 2014 | ||||
| IEC 60601-1-11:2015 | Same | |||
| Biocompatibility | ISO 10993-5 | |||
| ISO 10993-10 | ISO 10993-5 | |||
| ISO 10993-10 | ISO 10993-5 | |||
| ISO 10993-10 | Same |
7
Sponsor: Heat In A Click LLC
8
510(k) Number: K214015
Sponsor: Heat In A Click LLC
Comparison in Detail(s):
The subject device has all characteristic of predicate device K191940, a usability study is conducted. So, there is no difference between the two predicate devices.
9
510(k) Number: K214015 Sponsor: Heat In A Click LLC
9. Conclusion:
The subject device has all characteristic of predicate devices, and the result of usability study demonstrates that the subject device can meet the requirement for Over-The-Counter Use. Thus, the subject device is substantially equivalent to the predicate devices.