Synchrony FX2 Portable

GUDID 00858703006092

Powered muscle stimulator

ACCELERATED CARE PLUS CORP

Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device ID00858703006092
NIH Device Record Key71f8ee1d-f855-4d23-9e79-cd46db21aecb
Commercial Distribution StatusIn Commercial Distribution
Brand NameSynchrony FX2 Portable
Version Model Number300200A
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
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
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
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
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
GS100858703006092 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IPFStimulator, Muscle, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-10-23
Device Publish Date2016-08-16

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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

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