Device, Muscle Monitoring

Who Makes This Device Type in China?

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

Jiangyin Sinbon Electronics Co Ltd Jiangsu, contract manufacturer

What Is FDA Product Code KZM?

Device, Muscle Monitoring is FDA product code KZM, Class 2, 21 CFR 890.1375.

What Does It Take to Sell It in the United States?

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. The review can be done by an FDA-accredited third party, which is usually faster. 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, Muscle Monitoring

K7 Evaluation System-ESG

TMJ Vibration (Sound) Evaluation System. A lightweight headset holds highly sensitive vibration transducers over each TM joint, enabling simultaneous, bilateral capture of tissue vibrations…

Device, Muscle Monitoring

K7 EMG Electromyograph

Utilizing high quality bipolar surface electrodes, surface EMG data can be taken from up to eight muscle sites simultaneously and in real time. The program permits taking electromyography…

Device, Muscle Monitoring

MES 9000 Musculoskeletal System

Now you can have all of these capabilities in one compact system. Surface EMG, range of motion and muscle testing – may be purchased separately or in any combination. The modular design of…

Device, Muscle Monitoring

BioEMG

Indications for use: 8 channel EMG Amplifier 1. To record electrical activity of muscles of the stomatognathic system, especially temporalis, masseter and digastric. 2. To clinically…

Device, Muscle Monitoring

Monotrode 101

High quality disposable (single use) electrodes for surface electromyography (EMG).

Device, Muscle Monitoring

M-Scan

M-Scan records electrical activity from two craniofacial muscles, particularly the temporalis or masseter. It supports clinical assessment and treatment evaluation by comparing muscle…

Device, Muscle Monitoring

Nox A1 Carry Case

Catalogue number NOX-A1_CC, listed by Nox Medical Ehf, IS, under Device, Muscle Monitoring. 1 manufacturer in China is registered for this product code.

Device, Muscle Monitoring

Teethan

Indication for use: To record electrical activity of 2 muscles of the stomatognathic system, especially temporalis or masseter To clinically monitor 2 different muscles as an aid in the…

Device, Muscle Monitoring

Nox A1 Starter Sensor Kit, Pediatric

Catalogue number NOX-A1_SENSKIT2, listed by Nox Medical Ehf, IS, under Device, Muscle Monitoring. 1 manufacturer in China is registered for this product code.

Device, Muscle Monitoring

K7 Evaluation System-EMG

Utilizing high quality bipolar surface electrodes, surface EMG data can be taken from up to eight muscle sites simultaneously and in real time. The program permits taking electromyography…

Device, Muscle Monitoring

HindexRV

The HindexRV® Monitoring System is a physiological monitoring device that collects and transmits measurements (heart rate, respiration rate and muscle activity) using sensors. The HindexRV®…

Device, Muscle Monitoring

BioPAK

BioPAK: 1 catalogue number listed by BIO-Research Associates, Inc., United States, under Device, Muscle Monitoring. 1 manufacturer in China is registered for this product code.

Device, Muscle Monitoring

MES 9000 Dynamic EMG

The Dynamic SEMG module of the MES 9000 allows for the recording of up to 8 channels of SEMG simultaneously. The MES 9000 offers you the flexibility to monitor and record the data in its…

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