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CoolTone

FDA 510(k)

Class II (US FDA 510(k))

510(k) K192940

by Zimmer MedizinSysteme GmbH

Identifiers

510(k) Number
K192940 FDA 510(k)
FDA Product Code
NGX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 890.5850 FDA 510(k)
Regulation Number
890.5850 FDA 510(k)
Advisory Committee
Physical Medicine FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The CoolTone System is a neuromuscular electrical stimulation (NMES) device designed for adjunctive therapy in physical medicine. It delivers targeted electrical impulses to facilitate muscle activation, aiding in rehabilitation and muscle training protocols under medical supervision. The device is classified as substantially equivalent to the predicate BTL-899MS, adhering to regulatory standards for physical medicine applications. Its primary function is to assist in muscle stimulation and recovery processes, supporting therapeutic interventions for patients.

The CoolTone System is supplied as a reusable medical device and is intended for use in clinical or therapeutic settings. It operates under sterile conditions when in direct contact with the patient, though the device itself may not be single-use. The system is not labeled as MRI-safe or unsafe, and no specific storage requirements beyond standard medical equipment protocols are noted. Authorized for use in the United States under FDA 510(k) clearance (K253408), it follows regulatory pathways established for neuromuscular stimulation devices in physical medicine. No additional certifications or approvals beyond the stated FDA clearance are referenced.

Frequently asked questions

What is the CoolTone System used for?

The CoolTone System is designed as an adjunctive therapy in physical medicine to facilitate muscle activation through neuromuscular electrical stimulation (NMES). It supports rehabilitation and muscle training protocols under medical supervision, helping patients recover and strengthen muscles during therapeutic interventions.

Is the CoolTone System reusable or single-use?

The CoolTone System is supplied as a reusable medical device. While it is intended for clinical or therapeutic settings, the device itself is not labeled as single-use. Sterility is maintained when the device comes into direct contact with the patient, following standard sterile protocols for reusable medical equipment.

What regulatory clearance does the CoolTone System hold?

The CoolTone System holds FDA 510(k) clearance under the classification of substantially equivalent to the predicate device (BTL-899MS). It is authorized for use in the United States under clearance number K253408, adhering to regulatory standards for neuromuscular stimulation devices in physical medicine.

Are there any specific storage requirements for the CoolTone System?

The CoolTone System does not have unique storage requirements beyond those applicable to standard medical equipment. Users should follow general clinical protocols for maintaining cleanliness, functionality, and readiness for reuse in therapeutic settings.

Is the CoolTone System MRI-safe?

The CoolTone System is not labeled as MRI-safe or MRI-unsafe. Clinicians should verify compatibility with their specific MRI protocols and consult manufacturer guidelines before use in an MRI environment.

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: PDF Zimmer MedizinSysteme GmbH Scott Blood 151 Gleasondale Road Trade ..., Zimmer Medizinsysteme GmbH FDA 510 (k) Products - Latest 2026, Zimmer MedizinSysteme | Excellence in Medicine - und das seit 50 Jahren ..., K253408 FDA 510 (k) - CoolTone | Zimmer Medizinsysteme GmbH

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Zimmer MedizinSysteme GmbH

Sources (1)

  • FDA 510(k) K192940 24 fields · synced Oct 1, 2026