Synchrony Face & Neck PENS Electrode

GUDID 00858703006191

Cutaneous Electrode

ACCELERATED CARE PLUS CORP

Transcutaneous electrical stimulation electrode
Primary Device ID00858703006191
NIH Device Record Keybab27618-cf4e-4a13-a1e0-54ebe5ebb16f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSynchrony Face & Neck PENS Electrode
Version Model Number74921
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 Usefalse
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
GS100858703006191 [Primary]
GS110858703006198 [Package]
Package: [10 Units]
In Commercial Distribution

FDA Product Code

GXYElectrode, Cutaneous

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

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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

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