Synchrony Oro-Facial sEMG Electrode

GUDID 00858703006207

Electrocardiograph electrode

ACCELERATED CARE PLUS CORP

Electrocardiographic lead set, single-use Electrocardiographic lead set, single-use Electrocardiographic lead set, single-use Electrocardiographic lead set, single-use Electrocardiographic lead set, single-use Electrocardiographic lead set, single-use Electrocardiographic lead set, single-use Electrocardiographic lead set, single-use Electrocardiographic lead set, single-use Electrocardiographic lead set, single-use Electrocardiographic lead set, single-use Electrocardiographic lead set, single-use Electrocardiographic lead set, single-use Electrocardiographic lead set, single-use Electrocardiographic lead set, single-use Electrocardiographic lead set, single-use Electrocardiographic lead set, single-use
Primary Device ID00858703006207
NIH Device Record Keye072fc42-28d9-46f1-a1c2-f779b9ebb786
Commercial Distribution StatusIn Commercial Distribution
Brand NameSynchrony Oro-Facial sEMG Electrode
Version Model Number61879
Company DUNS828331616
Company NameACCELERATED CARE PLUS CORP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100858703006207 [Primary]
GS110858703006204 [Package]
Package: [15 Units]
In Commercial Distribution

FDA Product Code

DRXElectrode, Electrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-08-16

Devices Manufactured by ACCELERATED CARE PLUS CORP

00858703006375 - OmniTour2023-12-04 Therapy cycling feedback software
00858703006313 - OmniFlow Software2023-09-14 Respiratory assessment and exercise software
B179OMNI13E87E4 - OmnisEMG2023-09-14 Biomechanical function analysis / interactive rehabilitation system
00858703006337 - Synchrony Dysphagia Solutions by ACP2023-09-11 Bioelectrical signal analysis software; Biomechanical function analysis, interactive rehabilitation system
00858703006351 - OmniVR Elite2023-09-11 Virtual display rehabilitation system
04041925002799 - OmniCycle Elite2023-09-11 Powered exercise therapy bicycle
04041925002805 - OmniStand2023-09-11 Exerciser, non-measuring for stroke rehabilitation
00858703006139 - OmniVersa2023-08-25 Combination electrical stimulation/ultrasound for physical therapy

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.