FDA.reportPublic FDA data

Bagnoli-8 EMG System

Primary DI
00851679007018
Brand
Bagnoli-8 EMG System
Company
DELSYS, INC.
Model
DS-B03
Device description
Biofeedback Device
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K990356000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K990356000THE BAGNOLI-8 EMG SYSTEMDelsys, Inc.1999-04-29HCC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851679007018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851679007018008516790070188516790070180851679007018

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
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
00851679007025Bagnoli-16 EMG SystemDS-B042016-09-22

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