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…

Registry build 21.09.26

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 monitor up to eight different muscles as an aid in the diagnosis and treatments evaluation by recording the electrical activity of muscles of the stomatognathic system. 3. To determine the degree of relaxation (intra-patient) of a single muscle/group of muscles at rest. 4. To measure relative (intra-patient) levels of activity of several muscles during a functional act. Indications for use: 2 channel JVA amplifier 1. To record and display sounds/vibrations from the temporomandibular joints. 2. To aid the clinician in their analysis of a joint sound/vibration by allowing them to see the waveform in various standard plots. 3. To aid the clinician in comparing a patient’s current stand plots to previous recordings before, during, and after treatment. 4. To provide numerical values that can be used to quantify the physical characteristics of the sounds/vibrations, allowing intra-patient comparisons (only) by the clinician.

1manufacturer
1catalogue number
5510(k) clearances naming this product code

Who Else Makes It

Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code KZM
Manufacturer City Province Registered as Device types
Jiangyin Sinbon Electronics Co Ltd Jiangyin Jiangsu Contract manufacturer 13

Record

Regulatory record for BioEMG
Listed by BIO-Research Associates, Inc., United States
FDA product code KZM
Device type Device, Muscle Monitoring
Device class Class 2
Regulation 21 CFR 890.1375
Establishment Complaint-file establishment, Manufacturer
510(k) K082927
Record published 2023-06-22

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries lot or batch number, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for BioEMG
Catalogue number Size Status
III NRG V2 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
HindexRV HHS Systems, Inc. 2
M-Scan BIO-Research Associates, Inc. 2
MES 9000 Dynamic EMG Myotronics-Noromed, Inc. 1
BioPAK BIO-Research Associates, Inc. 1
K7 Evaluation System-EMG Myotronics-Noromed, Inc. 1
Nox A1 Starter Sensor Kit, Pediatric Nox Medical Ehf 1
Teethan BTS SPA 1
Nox A1 Carry Case Nox Medical Ehf 1
Monotrode 101 Myotronics-Noromed, Inc. 1
MES 9000 Musculoskeletal System Myotronics-Noromed, Inc. 1
K7 EMG Electromyograph Myotronics-Noromed, Inc. 1
K7 Evaluation System-ESG Myotronics-Noromed, Inc. 1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K130158 2013-07-25
K082927 2009-02-06
K003176 2001-01-04
K981563 1998-09-15
K873947 1988-04-27

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

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