FDA.reportPublic FDA data

Winner EVO Combo

Primary DI
00853904006193
Brand
Winner EVO Combo
Company
Compass Richmar, LLC
Model
400-079
Device description
Winner CM2P-portable 2 channel combo in a hard carry case
Published
2016-11-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LIHInterferential Current Therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LIHInterferential Current TherapyNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013771000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013771000MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICERich-Mar Corp.2002-01-18IPF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853904006193PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853904006193008539040061938539040061930853904006193

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy ultrasound/neuromuscular stimulation systemAn assembly of devices that includes a neuromuscular electrical stimulator as an integral part of a therapeutic ultrasound system intended for the simultaneous delivery of ultrasound and electrical energies for physical therapy, typically to help prevent scar tissue formation in healing tissues and to help reduce muscle spasms and pain; it may in addition be capable of delivering either energy alone. The system is designed to produce a rhythmic contraction/release of injured muscles to promote the removal of metabolic by-products while applying ultrasound treatments.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10853904006046BodyMed Iontophoresis Electrode KitSmall, Box of 122016-05-02
10853904006053BodyMed Iontophoresis Electrode KitMedium, Box of 122016-05-02
10853904006060BodyMed Iontophoresis Electrode KitLarge, Box of 122016-05-02
10853904006077BodyMed Iontophoresis Electrode KitButterfly, Box of 122016-05-02
10850958007159GelShotGSA2CH12016-11-23
10853904006398GelShotGAS5CH22016-11-23
10850689007312STICK-E-PADS203-6782016-11-18
10850689007329STICK-E-PADS203-6792016-11-18
10850689007336STICK-E-PADS203-6742016-11-18
10850689007343STICK-E-PADS203-6752016-11-18
10850689007350STICK-E-PADS203-6732016-11-18
10850689007367STICK-E-PADS203-6722016-11-18
10850689007374STICK-E-PADS203-6802016-11-18
10850689007381STICK-E-PADS203-6812016-11-18
10850689007398STICK-E-PADS203-6762016-11-18
10850689007404STICK-E-PADS203-6772016-11-18
10850689007428ValueStim202-6752016-11-18
10850689007442ValueStim202-6762016-11-18
10850689007466Adhesive Electrodes202-4542016-11-18
10850689007473Adhesive Electrodes202-4552016-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860012519507CPS-2000SURGITECH, INC.LIH2025-03-31
00860012846917HakomedHAKOMED ASIA COMPANY LIMITEDLIH2024-10-08
24712832961182GEM-STIMGEMORE TECHNOLOGY CO., LTD.LIH2023-09-04
24712832961250GEM-STIMGEMORE TECHNOLOGY CO., LTD.LIH2023-09-04
24712832961274GEM-STIMGEMORE TECHNOLOGY CO., LTD.LIH2023-09-04
24712832961281GEM-STIMGEMORE TECHNOLOGY CO., LTD.LIH2023-09-04
24712832961403GEM-STIMGEMORE TECHNOLOGY CO., LTD.LIH2023-09-04
24712832961410GEM-STIMGEMORE TECHNOLOGY CO., LTD.LIH2023-09-04
24712832961427GEM-STIMGEMORE TECHNOLOGY CO., LTD.LIH2023-09-04
24712832961045GEM-STIMGEMORE TECHNOLOGY CO., LTD.LIH2023-09-01
04712832961058GEM-STIMGEMORE TECHNOLOGY CO., LTD.LIH2023-09-01
04712832961065GEM-STIMGEMORE TECHNOLOGY CO., LTD.LIH2023-09-01
04712832961072GEM-STIMGEMORE TECHNOLOGY CO., LTD.LIH2023-09-01
24712832961083GEM-STIMGEMORE TECHNOLOGY CO., LTD.LIH2023-09-01
04712832960211GEM-STIMGEMORE TECHNOLOGY CO., LTD.LIH2023-08-18
24712832960475GEM-STIMGEMORE TECHNOLOGY CO., LTD.LIH2023-08-18
00860009424708CS6101 Interferential StimulatorControl Solutions LLCLIH2023-03-20
00860009424715CS6101 Interferential KitControl Solutions LLCLIH2023-03-20
00860009424722CS6101 Interferential KitControl Solutions LLCLIH2023-03-20
00860009424739High Voltage Galvanic StimulatorControl Solutions LLCLIH2023-03-20
00860009424746High Voltage Galvanic Stimulator KitControl Solutions LLCLIH2023-03-20
00860009424753High Voltage Galvanic Stimulator KitControl Solutions LLCLIH2023-03-20
00860009424760CS6101-2 Interferential StimulatorControl Solutions LLCLIH2023-03-20
00860009424777Leadwire Set for CS6101 StimulatorControl Solutions LLCLIH2023-03-20
00860009424784Leadwire Set for CS6102 StimulatorControl Solutions LLCLIH2023-03-20
00860009424791CS6101-1 Interferential StimulatorControl Solutions LLCLIH2023-03-20
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
00860009424838CS6101-3 Interferential StimulatorControl Solutions LLCLIH2023-03-20