FDA.reportPublic FDA data

BNS-40 Home Treatment Unit

Primary DI
D79245000
Brand
BNS-40 Home Treatment Unit
Company
MYOTRONICS NOROMED, INC
Model
BNS-40
Catalog number
4500
Device description
The BNS-40 is a miniaturized version of the Myomonitor designed to allow the patient to safely apply electrical stimulation while at home to relax tense muscles.
Published
2016-08-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NUWStimulator, Muscle, Powered, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUWStimulator, Muscle, Powered, DentalPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D79245000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Analgesic transcutaneous electrical nerve stimulation systemAn assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2062434214info@myotronics.com

Regulatory Flags#

DUNS number
053824652
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D79261451Myotronics 6145 Duotrodes 61452016-09-19
D792N12011Norotrode 20N1202016-09-19
D7921013Monotrode 1011012016-09-19
D792N36010Noromed NT-360 InclinometerNT3602017-02-11
D792N9000M0MES 9000 Musculoskeletal System N9000M2016-09-19
D792N9200A0MES 9000 Dynamic EMGMES 9000 EMG2017-02-11
D792N9600A0MES 9000 Muscle TesterMuscle Tester2016-09-19
D79243001Myotrode SG Solid Gel TENS Electrodes43002016-09-19
D79240602Myotrode One With Gel40602016-09-19
D79240702Myotrode One without Gel40702016-09-19
D79244500J5 Myo-MonitorJ544502016-08-18
D79209830K7 ESG-2 ElectrosonographESG-209832016-08-18
D79243003Myotrode SG Solid Gel TENS Electrodes43002016-09-19
D792N12013Norotrode 20N1202016-09-19
D792N150MES0MES 9000 Static Electromyography ScannerStatic EMG Scanner2016-09-19
D792N91500MES 9000 Musculoskeletal System N9000M2016-09-19
D79209750K7 Evaluation System-ESGK7/ESG2016-09-19
D79209930K7 Evaluation System-EMGK7/EMG2016-09-19
D0792009780K7 Evaluation System-ESGK7/ESG2016-09-19
D07920978K7 Evaluation System-EMGK7/EMG2016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B108785APMMUS10EMFACE controllerBTL INDUSTRIES LIMITEDNUW2023-06-28
04983087012394D functionITO CO., LTD.NUW2021-09-09
D79243001Myotrode SG Solid Gel TENS ElectrodesMYOTRONICS NOROMED, INCNUW2016-09-19
D7921013Monotrode 101MYOTRONICS NOROMED, INCNUW2016-09-19
D79240602Myotrode One With GelMYOTRONICS NOROMED, INCNUW2016-09-19
D79240702Myotrode One without GelMYOTRONICS NOROMED, INCNUW2016-09-19
D79243003Myotrode SG Solid Gel TENS ElectrodesMYOTRONICS NOROMED, INCNUW2016-09-19
D79244500J5 Myo-MonitorMYOTRONICS NOROMED, INCNUW2016-08-18