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FDA 510(k)

Therm-X

K-Number: K190854 · 2019-05-10

ApplicantZenith Technical Innovations
Decision Date2019-05-10
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Therm-X is a medical device manufactured by Zenith Technical Innovations. It received FDA 510(k) clearance on 2019-05-10 under approval number K190854. 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?

Therm-X is a medical device that received FDA 510(k) clearance on 2019-05-10. It is manufactured by Zenith Technical Innovations. The 510(k) number is K190854.

When was Therm-X approved by the FDA?

Therm-X received FDA 510(k) clearance on 2019-05-10, under approval number K190854.

What company makes Therm-X?

Therm-X is manufactured by Zenith Technical Innovations.

What is the FDA product code for Therm-X?

The FDA product code for Therm-X is IRP.

Other Devices by Zenith Technical Innovations

K181149Therm-X Pro, Therm-X AT, Therm-X Pro Athlete 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

View on FDA Database →

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

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