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BioEMG

FDA UDI

Class II (US FDA UDI)

by Bio-Research Associates, Inc.

Identity

Trade Name
BioEMG FDA UDI
Generic Name
Jaw physiology evaluation system FDA UDI
Device Name
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. FDA UDI
Model / Reference
III NRG V2 FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
00860003499900 FDA UDI
510(k) Number
K082927 FDA UDI
FDA Product Code
KZM FDA UDI
GMDN Term
Jaw physiology evaluation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.1375 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Jaw physiology evaluation system

BioEMG by Bio-Research Associates, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Jaw physiology evaluation system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bio-Research Associates, Inc.

Sources (1)

  • FDA UDI 0d6a683f-add5-47a3-866b-945c1231a140 35 fields · synced Jun 1, 2026