PROFILE EMS

Primary DI
05060079210347
Brand
PROFILE EMS
Company
BODY CLOCK HEALTH CARE LIMITED
Model
EM-PROFILE_EMS
Device description
The PROFILE EMS is a symmetrical biphasic neuromuscular electronic stimulator intended for medical purposes, which repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. It is indicated for the following:- Prevention or retardation of muscle disuse atrophy; - Relaxation of muscle spasm;- Muscle reeducation; - Maintaining and increasing the range of motion; - Increasing local blood circulation;- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
Published
2017-02-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
05060079210347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060079210347050600792103475060079210347

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

Regulatory Flags#

DUNS number
504712829
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B364792117400USA 40x100 Body Clock Branded ElectrodesElectrodes Size 40 x 100mm2017-01-06
05060079210101Profile TENSTN-PROFILETENS2017-02-12
05060079210217Flexi TENSTN-FLEXITENS2017-02-12
05060079210224Smart TENSTN-SMARTTENS2017-02-12
05060079210262STIMPLUS PROAC-STIMPLUS_PRO2017-02-12
05060079210675SensaTONEPF-SENSATONE2017-02-12
05060079211283SensaTONE for MENPF-SENSATONEMEN2017-02-12
05060079211733Obi TENSOB-USA_OBITENS2017-02-12

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