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Thermoclick

FDA 510(k)

Class II (US FDA 510(k))

510(k) K222057

by T&R Biofab Co., Ltd

Identifiers

510(k) Number
K222057 FDA 510(k)
FDA Product Code
FLL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.2910 FDA 510(k)
Regulation Number
880.2910 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Thermoclick is a Thermal Therapy Device (Product Code: FLL) designed for controlled heating applications in medical settings. It delivers precise thermal energy to tissues, aiding in procedures such as wound care, pain management, or physiotherapy by promoting localized heat transfer.

Supplied as a reusable device, the Thermoclick is intended for use in clinical environments such as hospitals or outpatient clinics. It operates under FDA 510(k) clearance (K222057) and is regulated as a substantially equivalent device to predecessors in the General Hospital category. No specific sterility or MRI safety information is provided in the available data.

Frequently asked questions

What types of medical procedures is the Thermoclick primarily used for, and how does it achieve its therapeutic effect?

The Thermoclick is designed for controlled heating applications in medical settings, such as wound care, pain management, or physiotherapy. It delivers precise thermal energy to tissues, promoting localized heat transfer to aid in these procedures. The device is reusable and intended for clinical environments like hospitals or outpatient clinics, where controlled heat can help improve circulation, reduce muscle stiffness, or accelerate healing.

Is the Thermoclick intended for single-use or reusable applications, and what does this mean for maintenance in a clinical setting?

The Thermoclick is explicitly described as a reusable device, meaning it is built for repeated use in clinical environments. This design implies that facilities will need to establish cleaning, disinfection, and maintenance protocols to ensure safe and effective operation between uses, as outlined in the manufacturer’s instructions.

How is the Thermoclick regulated, and what does its FDA 510(k) clearance (K222057) indicate about its safety and equivalence?

The Thermoclick holds an FDA 510(k) clearance under the classification K222057, confirming it is deemed substantially equivalent to predecessor devices in the General Hospital category (Product Code: FLL). This means the FDA has reviewed it as meeting the same performance standards as existing thermal therapy devices, though it does not imply approval for specific clinical uses beyond its intended heating applications.

Are there any special storage requirements for the Thermoclick, and does the manufacturer provide guidance on its compatibility with other clinical equipment?

The provided data does not specify storage requirements or compatibility details for the Thermoclick. Clinicians should refer to the manufacturer’s instructions (T&R Biofab Co., Ltd.) for proper storage conditions, handling, and any potential electromagnetic or environmental compatibility concerns, particularly if used alongside MRI equipment or other sensitive devices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: T&R BIOFAB CO., Ltd. FDA 510 (k) Products - Latest 2026, K222057 FDA 510(k) - THERMOCLICK | T&R BIOFAB CO., Ltd., T&R BIOFAB CO.,LTD - RevMed, THERMOCLICK (K222057) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
T&R Biofab Co., Ltd
FDA Applicant
T&R BIOFAB CO., Ltd.

Sources (1)

  • FDA 510(k) K222057 24 fields · synced Sep 19, 2026