FDA 510(k)

Therm-X Pro, Therm-X AT, Therm-X Pro Athlete

K-Number: K181149 · 2018-08-03

Decision Date2018-08-03

Product CodeIRP

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

Therm-X Pro, Therm-X AT, Therm-X Pro Athlete is a medical device manufactured by Zenith Technical Innovations. It received FDA 510(k) clearance on 2018-08-03 under approval number K181149. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Therm-X Pro, Therm-X AT, Therm-X Pro Athlete?

Therm-X Pro, Therm-X AT, Therm-X Pro Athlete is a medical device that received FDA 510(k) clearance on 2018-08-03. It is manufactured by Zenith Technical Innovations. The 510(k) number is K181149.

When was Therm-X Pro, Therm-X AT, Therm-X Pro Athlete approved by the FDA?

Therm-X Pro, Therm-X AT, Therm-X Pro Athlete received FDA 510(k) clearance on 2018-08-03, under approval number K181149.

What company makes Therm-X Pro, Therm-X AT, Therm-X Pro Athlete?

Therm-X Pro, Therm-X AT, Therm-X Pro Athlete is manufactured by Zenith Technical Innovations.

What is the FDA product code for Therm-X Pro, Therm-X AT, Therm-X Pro Athlete?

The FDA product code for Therm-X Pro, Therm-X AT, Therm-X Pro Athlete is IRP.

Other Devices by Zenith Technical Innovations

K190854Therm-X K193550Therm-X K231912Therm-X K240125Therm-X (Home); Therm-X (AT)

Related Devices (Code: IRP)

K160608NormaTec Pulse and NormaTec Pulse ProNormaTec Industries, LP K171685Med4 EliteCool Systems, Inc. (Dba Game Ready) K161907Pressure Therapy SystemXiamen Senyang Co., Ltd. K163280RP Lite 760RMego Afek AC , Ltd. K160178Lympha-Flow(LF1200)Daesung Maref Co., Ltd. K183169Pulse 2.0, Pulse Pro 2.0NormaTec Industries, LP

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.