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

FDA 510(k) K181149 · Zenith Technical Innovations

Substantially Equivalent

510(k) numberK181149

Submission

Device name
Therm-X Pro, Therm-X AT, Therm-X Pro Athlete
Applicant
Zenith Technical Innovations
Gurnee, IL, US
Received
May 1, 2018
Decision date
August 3, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IRP – Massager, Powered Inflatable Tube
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5650
Specialty
Physical Medicine

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More from Ningbo Zhenhai Yihao Electronic Technology Co., Ltd.

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K193550Therm-XIRP · Traditional 02/28/2020SE
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Questions and answers

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

Therm-X Pro, Therm-X AT, Therm-X Pro Athlete (K181149) received a 510(k) decision of Substantially Equivalent on August 3, 2018, 94 days after the submission was received.

What is the product code of K181149?

The FDA product code is IRP – Massager, Powered Inflatable Tube, a Class II (moderate risk) device regulated under 21 CFR 890.5650.