FDA.reportPublic FDA data

Trigno Avanti 12-inch Snap Lead EMG Sensor

Primary DI
00851679007261
Brand
Trigno Avanti 12-inch Snap Lead EMG Sensor
Company
DELSYS, INC.
Model
SP-W06-018B
Device description
Trigno System Component
Published
2019-06-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00851679007261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851679007261008516790072618516790072610851679007261

GMDN Terms#

Term, Definition table
TermDefinition
Psychophysiological biofeedback systemA computerized device assembly designed for analysis and real-time feedback (biofeedback) of a variety of physiological parameters [e.g., heart rate, respiration, skin conductance, skin temperature, range of motion, force output, electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG) data] to assist a patient in developing a degree of conscious control over typically involuntary functions, usually for relaxation training and muscle re-education. It includes multiple pieces of patient monitoring hardware (e.g., electrodes, sensors), computer interface devices, and dedicated software; it is intended to be used with an off-the-shelf computer.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
826428344
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851679007360Trigno Avanti SensorSP-W112024-05-06
00851679007377Trigno CentroSP-W102024-05-06
00851679007384Trigno Charge-16SP-W092024-05-06
00851679007407Trigno Avanti Sensor, 4-PackSP-W112024-05-06
00851679007391Trigno Wireless Biofeedback SystemDS-T042024-04-12
00851679007353Trigno Maize SensorSP-W06-0292020-12-23
00851679007346Trigno Avanti Duo SensorSP-W06-0272020-01-24
00851679007339Trigno Avanti EKG Biofeedback SensorSP-W06-0212019-10-23
00851679007322Trigno Avanti Load Cell AdapterSP-W06-0222019-10-09
00851679007315Trigno Avanti Goniometer AdapterSP-W06-0232019-10-01
00851679007308Trigno Avanti Analog Input AdapterSP-W06-0252019-08-29
00851679007292Trigno Avanti FSR AdapterSP-W06-0202019-07-25
00851679007285Trigno Avanti Spring Contact AdapterSP-W06-0192019-07-08
00851679007254Trigno Avanti Snap Lead EMG SensorSP-W06-018A2019-06-14
00851679007247Trigno Avanti Mini SensorSP-W06-0242019-05-15
00851679007223Trigno Galileo SensorSP-W06-0172019-02-01
00851679007230Trigno Quattro SensorSP-W06-0162019-02-01
00851679007001Bagnoli-4 EMG SystemDS-B022016-09-15
00851679007018Bagnoli-8 EMG SystemDS-B032016-09-22
00851679007025Bagnoli-16 EMG SystemDS-B042016-09-22

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04560340091824Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
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00816271020407UltiumNoraxon U.S.A., Inc.HCC2026-03-30
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00816271020766UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020773CoreNoraxon U.S.A., Inc.HCC2026-03-30
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