Device, Sleep Assessment

Who Makes This Device Type in China?

One manufacturer in China holds an FDA registration for this device type, based in Guangdong. All of them are contract manufacturers, able to build to a buyer’s own specification.

Shenzhen Fenda Technology Co., Ltd. Guangdong, contract manufacturer

What Is FDA Product Code LEL?

Device, Sleep Assessment is FDA product code LEL, Class 2, 21 CFR 882.5050.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

Device, Sleep Assessment

Oxevision Sleep System

Sleep disorder interpretive software, professional-only

Device, Sleep Assessment

Braebon Ultima Body Position Sensor With 2.5 Mm Phone Connector

Catalogue number 0534, listed by Braebon Medical Corp., Canada, under Device, Sleep Assessment. 1 manufacturer in China is registered for this product code.

Device, Sleep Assessment

ActiGraph

The ActiGraph CentrePoint Insight Watch is a compact, battery-operated wearable activity recording device with physical characteristics similar to those of a small wristwatch. The watch is…

Device, Sleep Assessment

EasyNet

EasyNet Movement

Device, Sleep Assessment

Actiwave

Ambulatory Accelerometry recorder - triaxial

Device, Sleep Assessment

PRO-Diary

PRO-Diary is a body-worn recorder that combines physical activity monitoring with an electronic patient diary. An accelerometer measures limb or torso movement during daily living and…

Device, Sleep Assessment

MotionWatch

Ambulatory Physical Activity Recorder

Device, Sleep Assessment

Braebon Ultima Body Position Sensor

5 catalogue numbers from 0532, listed by Braebon Medical Corp., Canada, under Device, Sleep Assessment. 1 manufacturer in China is registered for this product code.

Device, Sleep Assessment

Neurovirtual

The Maxxi Position Sensor is intended for use with the polysomnograph system to acquire the body position of adult patients during sleep studies

Device, Sleep Assessment

Braebon Ultima Body Position Sensor for Alice 5

2 catalogue numbers from 0533, listed by Braebon Medical Corp., Canada, under Device, Sleep Assessment. 1 manufacturer in China is registered for this product code.

Device, Sleep Assessment

EmbraceMini

2 catalogue numbers from EmbraceMini stretchable band, listed by Empatica SRL, under Device, Sleep Assessment. 1 manufacturer in China is registered for this product code.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer