Omnistim FX2 Continence Plus Portable

GUDID 00858703006122

Non-implantable electrical stimulator for incontinence

ACCELERATED CARE PLUS CORP

Perineal orifice incontinence-control electrical stimulation system electrode Perineal orifice incontinence-control electrical stimulator electrode Perineal orifice incontinence-control electrical stimulator electrode Perineal orifice incontinence-control electrical stimulator electrode Perineal orifice incontinence-control electrical stimulator electrode Perineal orifice incontinence-control electrical stimulator electrode Perineal orifice incontinence-control electrical stimulator electrode Perineal orifice incontinence-control electrical stimulator electrode Perineal orifice incontinence-control electrical stimulator electrode Perineal orifice incontinence-control electrical stimulator electrode Perineal orifice incontinence-control electrical stimulator electrode Perineal orifice incontinence-control electrical stimulator electrode Perineal orifice incontinence-control electrical stimulator electrode Perineal orifice incontinence-control electrical stimulator electrode Perineal orifice incontinence-control electrical stimulator electrode Perineal orifice incontinence-control electrical stimulation system probe, reusable Perineal orifice incontinence-control electrical stimulation system probe, reusable Perineal orifice incontinence-control electrical stimulation system probe, reusable Perineal orifice incontinence-control electrical stimulation system probe, reusable Perineal orifice incontinence-control electrical stimulation system probe, reusable Perineal orifice incontinence-control electrical stimulation system probe, reusable Perineal orifice incontinence-control electrical stimulation system probe, reusable Perineal orifice incontinence-control electrical stimulation system probe, reusable Perineal orifice incontinence-control electrical stimulation system probe, reusable Perineal orifice incontinence-control electrical stimulation system probe, reusable Perineal orifice incontinence-control electrical stimulation system probe, reusable Perineal orifice incontinence-control electrical stimulation system probe, reusable Perineal orifice incontinence-control electrical stimulation system probe, reusable Perineal orifice incontinence-control electrical stimulation system probe, reusable Perineal orifice incontinence-control electrical stimulation system probe, reusable Perineal orifice incontinence-control electrical stimulation system probe, reusable Perineal orifice incontinence-control electrical stimulation system probe, reusable Perineal orifice incontinence-control electrical stimulation system probe, reusable Perineal orifice incontinence-control electrical stimulation system probe, reusable Perineal orifice incontinence-control electrical stimulation system probe, reusable Perineal orifice incontinence-control electrical stimulation system probe, reusable Perineal orifice incontinence-control electrical stimulation system probe, reusable Perineal orifice incontinence-control electrical stimulation system probe, reusable Perineal orifice incontinence-control electrical stimulation system probe, reusable Perineal orifice incontinence-control electrical stimulation system probe, reusable Perineal orifice incontinence-control electrical stimulation system probe, reusable Perineal orifice incontinence-control electrical stimulation system probe, reusable Perineal orifice incontinence-control electrical stimulation system probe, reusable Perineal orifice incontinence-control electrical stimulation system probe, reusable
Primary Device ID00858703006122
NIH Device Record Keyb068d695-1ee5-4356-9577-4cb7fd117659
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmnistim FX2 Continence Plus Portable
Version Model Number300100A
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100858703006122 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPIStimulator, Electrical, Non-Implantable, For Incontinence

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
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
04041925002805 - OmniStand2023-09-11 Exerciser, non-measuring for stroke rehabilitation
00858703006139 - OmniVersa2023-08-25 Combination electrical stimulation/ultrasound for physical therapy
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