FDA.reportPublic FDA data

FREEEMG

Primary DI
B179FR11
Brand
FREEEMG
Company
BTS SPA
Model
1000
Catalog number
BTSEMB1BM
Device description
BTS FREEEMG 1000 is a wireless surface electromyograph for the acquisition and transmission of EMG signals and for the assessment of angles, angular v
Published
2016-07-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HCCDevice, Biofeedback

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCCDevice, BiofeedbackNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B179FR11PackageHIBCC1In Commercial Distribution
B179FR1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
ElectromyographA mains electricity (AC-powered) device designed for the measurement and recording of the intrinsic electrical potential of skeletal muscle. The electromyograph (EMG) is typically used in clinical diagnosis of muscular disorders to evaluate muscle weakness and to determine if the weakness is related to the muscles themselves or a problem with the nerves that supply the muscles.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
428484518
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
true
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B179SEVBUN050SMARTDX EVO5SEVBUN052024-12-27
B179SEVBUN090SMARTDX EVO9SEVBUN092024-12-27
B179SEVBUN260SMARTDX EVO26SEVBUN262024-12-27
B179SEVBUN020SMARTDX EVO2SEVBUN022024-12-20
B179SDXEVO1SMARTDX EVOBTSNET82023-09-06
B179FE3FREEEMG300BTSFE32016-07-06
B179FR1FREEEMG1000BTSEMB1BM2016-07-06
B179THN2TEETHAN2.0BTSEMB1BM2017-09-26
B179TMJTMJOINT1.0BTSEMB1BM2017-02-12
B179OMNOMNIsEMG1.0BTSEMB1BM2017-02-12
B179BAIO1baiobit12020-12-14
B179BAIO11baiobit12020-12-14
B179SDXSMARTDXBTSSDX2017-02-12
B179THN1TEETHAN2.0BTSEMB1BM2017-09-26
B179FE31FREEEMG300BTSFE32016-07-06
B179GSN2G-SENSOR2BTSGSN22016-07-06
B179P6KP60006000BTSP6K2017-02-12
B179TMJ1TMJOINT1.0BTSEMB1BM2017-02-12

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Primary DI, Brand, Company table
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04560340091770Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091787Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091794Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
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