FDA.reportPublic FDA data

N/A

Primary DI
80092237612848
Brand
N/A
Company
COMPASS HEALTH BRANDS CORP.
Model
DM1000
Device description
Mini Stim EMS Device
Published
2016-10-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
IPFStimulator, Muscle, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPFStimulator, Muscle, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
80092237612848PackageGS1100Not in Commercial Distribution
00092237612842PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
8009223761284880092237612848
00092237612842000922376128420922376128420092237612842

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
440-572-1962CustomerService@compasshealthbrands.com
800-376-7263customerservice@compasshealthbrands.com

Regulatory Flags#

DUNS number
827221698
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
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
00092237613269Roscoe MedicalLS52662016-10-13
00194346678921Equate73085EQ2026-03-09
00714905117649Fab StimDT30252026-02-06
00714905710024Fab StimDT70252026-02-06
00860163000312CMS DT30292026-02-06
00092237622209SCRIPHESSCO672-0192-CH2026-02-03
00092237622216SCRIPHESSCO672-0193-CH2026-02-03
00092237622339SCRIPHESSCO672-0195-CH2026-02-03
30194346615156Equate 72085EQ2026-01-20
00092237627495Roscoe MedicalO2C6P2026-01-15
00023601130402CarexFGB30400 00002025-12-01
00092237622193SCRIPHESSCO672-0010-CH2025-11-24
00714905710062FabStimE1P3000TC2FS2025-11-18
00092237621967TwinStimDS5002-OTC2025-09-29
00092237902257MicroBlock Antimicrobial Electrode400-877-MIC2020-06-11
00092237902240MicroBlock Antimicrobial Electrode400-872-MIC2019-01-08
00092237902288MicroBlock Antimicrobial Electrode400-852-MIC2020-06-11
00092237902264MicroBlock Antimicrobial Electrode400-879-MIC2020-06-11
00092237902271MicroBlock Antimicrobial Electrode400-881-MIC2020-06-11
00092237611531Roscoe MedicalLS52552016-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809308380782Compact-IIEnraf-Nonius B.V.IPF2025-09-23
18885022060015Quantum Mitohormesis (QMT)QUANTUMTX PTE. LTD.IPF2025-07-21
00810188050083L300 Go SystemBioness Medical, Inc.IPF2025-07-18
00810188050120L300 Go SystemBioness Medical, Inc.IPF2025-07-18
00810188050274L300 Go SystemBioness Medical, Inc.IPF2025-07-18
00810188050069L360 Thigh SystemBioness Medical, Inc.IPF2025-07-17
00810188050090L300 Go SystemBioness Medical, Inc.IPF2025-07-17
00810188050113L300 Go SystemBioness Medical, Inc.IPF2025-07-17
00810188050137L300 Go SystemBioness Medical, Inc.IPF2025-07-17
00810188050243L300 Go SystemBioness Medical, Inc.IPF2025-07-17
00810188050342L300 Go SystemBioness Medical, Inc.IPF2025-07-17
08809851470091EVE Synergy; EVE TitanWEERO Co., Ltd.IPF2025-06-24
03830054238138QuantumStar, StarFormerFOTONA d.o.o.IPF2025-06-12
00860009465626STIMEL-03 Stimulating Electrodes MOTION INFORMATICS LTDIPF2024-11-26
00860009465602STIMEL-03MOTION INFORMATICS LTDIPF2024-11-17
17540176050091PreliviaRehabtronics IncIPF2024-11-12
17540176050107Prelivia ElectrodeRehabtronics IncIPF2024-11-12
17540176050114Prelivia ElectrodeRehabtronics IncIPF2024-11-12
10810113577194ViveVIVE HEALTH LLCIPF2024-08-20
00850022650444Motive Knee SystemMotive Health, Inc.IPF2024-08-12
00850022650451Motive Knee SystemMotive Health, Inc.IPF2024-08-12
00850022650468Motive Knee SystemMotive Health, Inc.IPF2024-08-12
16971763600190ROOVJOYShenzhen roundwhale technology co. LTD.IPF2024-07-31
03830054237728StarFormerFOTONA d.o.o.IPF2024-07-30
00092237626047Richmar EMG ProCOMPASS HEALTH BRANDS CORP.IPF2024-06-28
00092237626054Richmar EMG ProCOMPASS HEALTH BRANDS CORP.IPF2024-06-28
00850022650291Motive Knee SystemMotive Health, Inc.IPF2024-04-11
00850022650420Motive Knee SystemMotive Health, Inc.IPF2024-04-11
00850022650437Motive Knee SystemMotive Health, Inc.IPF2024-04-11
00817717023099VQ OrthoCareVision Quest Industries IncorporatedIPF2024-03-28