FDA.reportPublic FDA data

Insight Discovery EMG

Primary DI
00890477000098
Brand
Insight Discovery EMG
Company
SRS Medical Systems, Inc.
Model
900-037
Published
2021-08-19
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
IKNElectromyograph, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCCDevice, BiofeedbackNeurology2
IKNElectromyograph, DiagnosticPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063447000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063447000INSIGHT DISCOVERYFasstech2007-08-16IKN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00890477000098PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00890477000098008904770000988904770000980890477000098

GMDN Terms#

Term, Definition table
TermDefinition
Kinesiology/electromyographic sensor setA collection of patient-worn devices consisting of both an electromyographic sensor and motion-based sensor intended to be used in a clinical setting as part of a system (e.g., virtual-display rehabilitation system, biomechanical analysis system) to provide non-gravity-compensating analysis, biofeedback, and/or interactive rehabilitation of neuromuscular/musculoskeletal conditions. It is typically intended to be used with a computer, interface devices, and software (not included).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
796263598
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00890477000395Tri-Electrode Surface EMG730-0032026-03-04
00089047700395Tri-Electrode Surface EMG730-0032026-03-04
00890477000371EMG Elect. w/Lead Wire Set, EP (1 set of 3/bag)35700015S2026-01-21
00890477000388EMG Elect. w/Lead Wire Set, EP (1 set of 3/bag)35700015S2026-01-21
00890477000364EasyFlo Console900-0442023-04-26
00890477000326CT3000 Pro Base Unit900-0402020-09-29
00890477000166Discovery Base Unit900-0102018-06-25
00890477000074Insight Discovery Thermal 900-0342021-08-20
00890477000081Insight Discovery PWP900-0362021-08-20
00890477000104Insight Discovery Dual Inclinometer900-024-22021-08-20
00890477000159Insight Discovery Algometer900-015-22021-08-20
00890477000173Insight Discovery PWP (w/cable)900-0232021-08-20
00890477000180EMG Sensor900-0262021-08-20
00890477000296Insight Discovery Thermal (w/cable)900-014-22021-08-20
00890477000210UDS Pump213852021-08-20
00890477000142CT3000 Base Unit900-0272021-08-19
00890477000203Uroflow Scale900-0352021-08-19
00890477000258CT3000 ScaleCT3-022021-08-19
00890477000357UroFlow Scale900-0422021-08-17
00890477000333UroCuff-DC Disposable, Single730-0022020-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190376509747SafeOp 3ALPHATEC SPINE, INC.IKN2026-03-24
08719481550110NeXus 10 MK3Mind Media Europe B.V.HCC2025-09-10
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
50885380198791KangarooCardinal Health 200, LLCHCC2025-03-12
00190376517506SafeOp 3ALPHATEC SPINE, INC.IKN2024-11-12
00190376530024SafeOp 3ALPHATEC SPINE, INC.IKN2024-11-12
10853818007504USB C AdapterPRECISION BIOMETRICS INCHCC2024-09-03
B758000RDA483dorsaVi - V6 Overwrap AdhesivesDORSAVI LTDHCC2023-08-30
B758000RDA890dorsaVi - V6 EMG DAPDORSAVI LTDHCC2023-08-30
B758000RDA891dorsaVi - V6 Low Back AMI DAPDORSAVI LTDHCC2023-08-30
B758000VMPLU0ViMove+DORSAVI LTDIKN2023-08-30
B758000VMPLU0ViMove+DORSAVI LTDHCC2023-08-30
00092237624456Richmar EMG ProDrive Devilbiss HealthcareHCC2023-08-03
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
50885380195554NTRAINERCardinal Health 200, LLCHCC2023-07-03
50885380195561NTRAINERCardinal Health 200, LLCHCC2023-07-03
00195377153807PULSENuvasive, Inc.IKN2023-05-02
00195377153814PULSENuvasive, Inc.IKN2023-05-02
00195377083272NVM5Nuvasive, Inc.IKN2023-04-13