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HUANQIU Heating lamp, including CQ-27, CQ-29 and CQ-67, is an infrared lamp that emits the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature, to temporarily increase local blood circulation, and to temporarily relieve minor muscle and joint pain and stiffness. The lamps may also help to relieve minor pain associated with muscle spasms, minor sprains and strains, and minor muscular back pain.

The device consists of heating head, swing arm, control box and pedestal with extension. It is used to provide topical heating to the body and is specially engineered using a rare earth ceramic plate. Emission spectrum ranges from 2 to 50 microns. The emission heating plate should be replaced after 1,000 to 1500 hours of usage. 110 volt power, 250 watts. There are two different types of control: standard control and digital display control.

The HUANQIU Heating Lamp (models CQ-27, CQ-29, and CQ-67) is an infrared lamp device. The study to prove the device meets acceptance criteria is a substantial equivalence comparison to the predicate device, the TDP CQ-27 Heat Lamp manufactured by Lhasa Medical, Inc. This type of submission (510(k)) does not typically involve clinical trials in the way a pharmaceutical might, but instead focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the HUANQIU Heating Lamps are based on demonstrating substantial equivalence to the predicate device in terms of components, power, spectrum ranges, warming up time, total working hours, operating timer, number of fuses, inner cover diameter/width, number of casters, and skin temperature at specific distances.

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