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K Number
K181211
Device Name
Human Tecar HCR 1002
Manufacturer
UNIBELL S.r.l
Date Cleared
2018-09-10

(126 days)

Product Code
PBX
Regulation Number
878.4400
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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 Description

Not Found

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for the Human Tecar HCR 1002 device. It describes the device's indications for use and regulatory classification but does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot provide the requested information based on the given input. The document is primarily a regulatory communication confirming clearance, not a technical report or study summary.

§ 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.