FDA.report

Winner EVO Stim

Primary DI
00853904006162
Brand
Winner EVO Stim
Company
Compass Richmar, LLC
Model
410-014
Device description
Winner EVO-ST2-2 channel electrotherapy
Published
2016-11-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LIHInterferential Current Therapy

Product Code Classifications

CodeDeviceSpecialtyClass
LIHInterferential Current TherapyNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00853904006162PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00853904006162008539040061628539040061620853904006162

GMDN Terms

TermDefinition
Physical therapy transcutaneous electrical stimulation system, line-poweredAn assembly of mains electricity (AC-powered) devices used to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy. It typically includes an electric current pulse generator, electrodes/probes, audible and/or visual indicators, and software. It may provide biofeedback and/or transcutaneous electrical nerve stimulation (TENS) to treat pain. It is typically used to prevent muscle atrophy, for muscle re-education, to relax muscle spasms, to improve blood circulation, for postsurgical calf muscle stimulation to prevent venous thrombosis, and/or to maintain or increase range of motion.

Sterilization Methods

Method

Contacts

PhoneEmail
1-888-549-4945customerservice@richmarweb.com
800-376-7263customerservice@compasshealthbrands.com

Regulatory Flags

DUNS number
080930531
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00860009424807CS3101-TL2 Interferential StimulatorControl Solutions LLCLIH2023-03-20
00860009424814AC Power Adapter for CS6101 StimulatorControl Solutions LLCLIH2023-03-20
00860009424821AC Power Adapter for CS6102 StimulatorControl Solutions LLCLIH2023-03-20
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