Therm-X
K-Number: K193550 · 2020-02-28
ApplicantZenith Technical Innovations
Decision Date2020-02-28
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 2020-02-28 under approval number K193550. 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 2020-02-28. It is manufactured by Zenith Technical Innovations. The 510(k) number is K193550.
When was Therm-X approved by the FDA?
Therm-X received FDA 510(k) clearance on 2020-02-28, under approval number K193550.
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
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.