FDA.reportPublic FDA data

BioPAK

Primary DI
00860003499948
Brand
BioPAK
Company
Bio-Research Associates, Inc.
Model
9
Published
2023-06-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KZMDevice, Muscle Monitoring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZMDevice, Muscle MonitoringPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K981563000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981563000BIOPAK MEASUREMENT SYSTEMBio-Research Associates, Inc.1998-09-15KZM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860003499948PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003499948008600034999488600034999480860003499948

GMDN Terms#

Term, Definition table
TermDefinition
Jaw physiology evaluation systemAn assembly of mains electricity (AC-powered) devices designed to record parameters for mandibular and muscles of mastication function, primarily to aid in the diagnosis and treatment of temperomandibular joint (TMJ) and myofascial pain dysfunction (MPD) disorders, and for orthodontic, denture, and reconstruction patient evaluation. It typically uses surface electromyography to evaluate muscle groups at rest or in function; sonography to detect sounds/vibrations from the TMJ joint and/or other computer-based system to non-invasively track the mandible in function or identify its position in space relative to the skull.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4143577525info@bioresearchinc.com

Regulatory Flags#

DUNS number
063501373
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009598201Taylor IndustriesLong Term Monitoring Electrode2023-08-17
00860003499900BioEMGIII NRG V22023-06-22
00860003499917JT-3DNR 16 Channel2023-06-22
00860003499924BioJVAAmplifier 1608FS2023-06-22
00860003499931BioJVAHeadset2023-06-22
00860003499955M-ScanRest2023-06-22
00860003499962M-ScanClench2023-06-22
00860003499979QuadraTENSUnit2023-06-22
00860009598218BioJVAAmplifier USB-2312023-06-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860003499900BioEMGBio-Research Associates, Inc.KZM2023-06-22
00860003499955M-ScanBio-Research Associates, Inc.KZM2023-06-22
00860003499962M-ScanBio-Research Associates, Inc.KZM2023-06-22
15694311111665Noxturnal US APPNox Medical ehf.KZM2021-10-18
15694311111610Nox A1® EEG 5 Lead Gold Electrode CableNox Medical ehf.KZM2021-09-07
15694311111627Nox A1® EEG Head Cable Nox Medical ehf.KZM2021-09-07
15694311111566Nox A1s RecorderNox Medical ehf.KZM2021-07-10
15694311111580Nox A1s SystemNox Medical ehf.KZM2021-07-10
15694311111597Nox C1s KitNox Medical ehf.KZM2021-07-10
15694311110682Nox A1 Starter Sensor Kit, AdultNox Medical ehf.KZM2021-02-03
15694311110699Nox A1 Starter Sensor Kit, PediatricNox Medical ehf.KZM2021-02-03
15694311111498Nox C1 Access PointNox Medical ehf.KZM2021-02-03
15694311111504Nox C1 KitNox Medical ehf.KZM2021-02-03
00860001651911HindexRVHHS SYSTEMS, INC.KZM2021-01-20
15694311110095Nox A1 Carry CaseNox Medical ehf.KZM2020-04-27
15694311110453Nox A1 EEG 5 Lead Gold Electrode CableNox Medical ehf.KZM2020-04-27
15694311110521Nox A1 EEG Head CableNox Medical ehf.KZM2020-04-27
15694311110019Noxturnal APPNox Medical ehf.KZM2020-02-24
15694311110590Nox C1 Access PointNox Medical ehf.KZM2020-02-24
15694311110903Nox A1 RecorderNox Medical ehf.KZM2020-02-24
15694311111146Nox C1 KitNox Medical ehf.KZM2020-02-24
15694311111368Noxturnal PSG CDNox Medical ehf.KZM2020-02-24
15694311111375Nox A1 SystemNox Medical ehf.KZM2020-02-24
00860001651904HindexRVHHS SYSTEMS, INC.KZM2019-04-26
B179THN2TEETHANBTS SPAKZM2017-09-26
B179THN1TEETHANBTS SPAKZM2017-09-26
D792N9200A0MES 9000 Dynamic EMGMYOTRONICS NOROMED, INCKZM2017-02-11
D79209750K7 Evaluation System-ESGMYOTRONICS NOROMED, INCKZM2016-09-19
D79209930K7 Evaluation System-EMGMYOTRONICS NOROMED, INCKZM2016-09-19
D792N9000M0MES 9000 Musculoskeletal System MYOTRONICS NOROMED, INCKZM2016-09-19