FDA.reportPublic FDA data

B&L Engineering Active EMG Surface Electrode

Primary DI
00855144007046
Brand
B&L Engineering Active EMG Surface Electrode
Company
PINSCO, INC.
Model
BL-AE-N/NG
Device description
Active EMG Surface Electrode Narrow Spaced - No Ground
Published
2017-05-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IKNElectromyograph, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKNElectromyograph, DiagnosticPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K952655000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K952655000B & L ELECTRODEB & L Engineering1995-09-28IKN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855144007046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855144007046008551440070468551440070460855144007046

GMDN Terms#

Term, Definition table
TermDefinition
Electromyographic signal amplifierAn electronic device used with an electromyograph (EMG) to increase voltage, current, or power. This GMDN code may reflect old technology.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
714-505-9492sales@bleng.com

Regulatory Flags#

DUNS number
079605952
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855144007060B&L Engineering Active Surface EMG ElectrodeBL-AE-W/G2017-05-02
00855144007077B&L Engineering Active Surface EMG ElectrodeBL-AE-SNAP2017-05-02
00855144007008B&L Engineering Pinch GaugePG-602017-05-02
00855144007015B&L Engineering Pinch GaugePG-302017-05-02
00855144007022B&L Engineering Pinch GaugePG-102017-05-02
00855144007039B&L Engineering Hydraulic Hand DynamometerBL50012017-05-02
00855144007053B&L Engineering Active Surface EMG ElectrodeBL-AE-W/NG2017-05-02
00855144007084B&L Engineering EMG Electrode Interface BoxBL-EMG-62017-05-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190376509747SafeOp 3ALPHATEC SPINE, INC.IKN2026-03-24
00763000886790N/aMEDTRONIC XOMED, INC.IKN2025-06-23
08056446901106NExT-DOCKINGEB NEURO SPAIKN2025-05-22
08056446901113NExT-PADEB NEURO SPAIKN2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAIKN2025-05-22
08056446901137NExT-HSEB NEURO SPAIKN2025-05-22
08056446901168NExT-AMPEB NEURO SPAIKN2025-05-22
08056446901199NExT-ASEB NEURO SPAIKN2025-05-22
08056446901205NExT StationEB NEURO SPAIKN2025-05-22
08056446901090NExT Station AdvancedEB NEURO SPAIKN2025-05-19
00190376517506SafeOp 3ALPHATEC SPINE, INC.IKN2024-11-12
00190376530024SafeOp 3ALPHATEC SPINE, INC.IKN2024-11-12
B758000VMPLU0ViMove+DORSAVI LTDIKN2023-08-30
00195377153951PULSENuvasive, Inc.IKN2023-07-11
00195377153968PULSENuvasive, Inc.IKN2023-07-11
00195377153975PULSENuvasive, Inc.IKN2023-07-11
00195377060761PULSENuvasive, Inc.IKN2023-07-06
00195377060778PULSENuvasive, Inc.IKN2023-07-06
00195377153807PULSENuvasive, Inc.IKN2023-05-02
00195377153814PULSENuvasive, Inc.IKN2023-05-02
00195377083272NVM5Nuvasive, Inc.IKN2023-04-13
00195377097415NVM5Nuvasive, Inc.IKN2023-04-13
00195377097422NVM5Nuvasive, Inc.IKN2023-04-13
00195377097439NVM5Nuvasive, Inc.IKN2023-04-13
00190376458601SafeOpALPHATEC SPINE, INC.IKN2023-02-12
00190376459035SafeOpALPHATEC SPINE, INC.IKN2023-02-12
00195377108128PULSENuvasive, Inc.IKN2022-06-30
00195377108135PULSENuvasive, Inc.IKN2022-06-30
00195377049131PULSENuvasive, Inc.IKN2022-05-06
00195377049148PULSENuvasive, Inc.IKN2022-05-06