FDA.reportPublic FDA data

Synchrony Dysphagia Solutions by ACP

Primary DI
00858703006337
Brand
Synchrony Dysphagia Solutions by ACP
Company
ACCELERATED CARE PLUS CORP
Model
300800A
Device description
Bioelectrical signal analysis software; Biomechanical function analysis, interactive rehabilitation system
Published
2023-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous
HCCDevice, Biofeedback
IONExerciser, Non-Measuring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2
HCCDevice, BiofeedbackNeurology2
IONExerciser, Non-MeasuringPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858703006337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858703006337008587030063378587030063370858703006337

GMDN Terms#

Term, Definition table
TermDefinition
Bioelectrical signal analysis softwareA software program intended to acquire, process, store and analyse biological electrical signals, both in real-time and delayed time, for diagnostic applications. The signals are typically provided by electrophysiological recording/monitoring [e.g., electromyography (EMG), electroencephalography (EEG), evoked potentials (EP), bioelectrical impedance analysis (BIA)]. It may be installed in the recording/monitoring device, personal computer, or data network server. It is neither intended for continuous bedside nor intraoperative monitoring, and is not dedicated to hearing analysis.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-350-1100acp-customersupport@hanger.com

Regulatory Flags#

DUNS number
828331616
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858703006054Neuroprobe 500 Pro140500B2016-08-16
00858703006252Ultraphonic (250ml Bottle)455392016-09-06
00858703006269Ultraphonic, 5 Liter w/ bottle320602016-09-06
00858703006061Omnipad Light Therapy, Dual 5x7 Pads768962016-08-16
00858703006399OmniCycle Elite 7 Inch Screen Motorized Therapeutic Exercise SystemA007-5332024-10-21
00858703006382OmniTour System300800T2024-09-10
00858703006207Synchrony Oro-Facial sEMG Electrode618792016-08-16
00858703006214Electrodes Pharyngeal sEMG341842016-08-16
00858703006375OmniTourOmniTourSoftware2023-09-12
00858703006313OmniFlow SoftwareFlowSoftware2023-09-06
00858703006092OmniStim FX2 Portable PENS300200A-12016-08-16
00858703006276OmniFlow Therapy System100FLO2023-09-12
00858703006344ACPlus Respiratory AssessmentARASoftware2023-09-12
00858703006368ACPlus Platform100ACPLUS2023-09-12
B179OMNI13E87E4OmnisEMG441442023-09-06
00858703006351OmniVR Elite300600C2023-09-01
00858703006139OmniVersa100FXF2023-08-17
00858703006320OmniME100MTS2023-08-17
00858703006078Megapulse II19030292016-08-16
00858703006122Omnistim FX2 Continence Plus Portable300100A2016-08-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720791379131EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379148EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379155EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379162EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379179EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379209EZ1020Technomed Engineering B.V.GXY2026-08-07
09120077180311Elvistyromotion GmbHION2026-08-03
08054040401879BIKOORMESA SRLION2026-08-01
08054040401886BIKOORMESA SRLION2026-08-01
08054040401893BIKOORMESA SRLION2026-08-01
08054040401909BIKOORMESA SRLION2026-08-01
08054040401916BIKOORMESA SRLION2026-08-01
08054040401923BIKOORMESA SRLION2026-08-01
08054040401930BIKOORMESA SRLION2026-08-01
08054040401947BIKOORMESA SRLION2026-08-01
08054040401954BIKOORMESA SRLION2026-08-01
08054040401961BIKOORMESA SRLION2026-08-01
08054040401978BIKOORMESA SRLION2026-08-01
08054040401985BIKOORMESA SRLION2026-08-01
08054040401992BIKOORMESA SRLION2026-08-01
08054040402005BIKOORMESA SRLION2026-08-01
08054040402876BIKOORMESA SRLION2026-08-01
08054040403729BIKOORMESA SRLION2026-08-01
00860015825803JOGO-GxJogohealth, Inc.HCC2026-07-27
00850080988640AUVONUAN HEALTHCARE LIMITEDGXY2026-07-22
00850080988633AUVONUAN HEALTHCARE LIMITEDGXY2026-07-17
00850080988602AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988619AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988626AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850053287411ReCureNiche Biomedical, Inc.GXY2026-07-14