Human Tecar HCR 1002
Device Facts
| Record ID | K181211 |
|---|---|
| Device Name | Human Tecar HCR 1002 |
| Applicant | Unibell S.R.L |
| Product Code | PBX · General, Plastic Surgery |
| Decision Date | Sep 10, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The Human Tecar HCR 1002 is a temporary diathermy device for topical heating in order to increase the patient's tissue temperature for treating: relief of pain, muscle spasms, increase in local circulation. The device has also been designed to provide massage aiming to temporarily reduce the cellulite appearance.
Device Story
Human Tecar HCR 1002 is a temporary diathermy device; provides topical heating to increase tissue temperature; used for pain relief, muscle spasms, and increasing local circulation; also provides massage to temporarily reduce cellulite appearance. Operated by healthcare professionals in clinical settings. Device applies energy to patient tissue; mechanism involves diathermy for thermal effects. Output used by clinicians to manage musculoskeletal conditions and aesthetic concerns.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Diathermy device for topical heating; Class II; Product Code PBX; Regulation 21 CFR 878.4400. Electrosurgical cutting and coagulation device and accessories category.
Indications for Use
Indicated for patients requiring topical heating for pain relief, muscle spasm reduction, and increased local circulation. Also indicated for massage to temporarily reduce cellulite appearance.
Regulatory Classification
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.
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Submission Summary (Full Text)
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September 10, 2018
UNIBELL S.r.1 % Ms. Marisa Testa QA/RA Manager Thema S.r.1 Via Saragat, 5 Imola, 40026 It
Re: K181211
Trade/Device Name: Human Tecar HCR 1002 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: PBX Dated: August 6, 2018 Received: August 10, 2018
Dear Ms. Testa:
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/cfpmr/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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 entiled, "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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
## Jennifer R. Stevenson -S3
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K181211
Device Name Human Tecar HCR 1002
Indications for Use (Describe)
The Human Tecar HCR 1002 is a temporary diathermy device for topical heating in order to increase the patient's tissue temperature for treating: relief of pain, muscle spasms, increase in local circulation.
The device has also been designed to provide massage aiming to temporarily reduce the cellulite appearance.
Type of Use (Select one or both, as applicable)
| <span style="font-size:10px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:10px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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