FDA.reportPublic FDA data

Trigno Spring Contact Adapter

Primary DI
00851679007094
Brand
Trigno Spring Contact Adapter
Company
DELSYS, INC.
Model
SP-W01B
Device description
Trigno System Component
Published
2016-09-22
Public version status
Update
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
00851679007094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851679007094008516790070948516790070940851679007094

GMDN Terms#

Term, Definition table
TermDefinition
Biofeedback systemAn assembly of devices intended to provide visual and/or auditory signals corresponding to the status of one or more of a patient's physiological functions, e.g., brain wave activity, muscle activity, blood pressure, skin temperature, balance, so that the patient can develop some degree of conscious control over a usually involuntarily function. This system will detect changes in the physiological functions that are outside of the normal awareness, amplify these signals, and provide this as feedback to the patient. It is used in, e.g., tension headache control, muscle relaxation, rehabilitation/training, behavioural research.

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
00851679007261Trigno Avanti 12-inch Snap Lead EMG SensorSP-W06-018B2019-06-14
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

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04560340091749Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
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