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510(k) Data Aggregation
K Number
K221958Device Name
Flex-MI
Manufacturer
Date Cleared
2022-10-21
(108 days)
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
EMSI, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Interferential Stimulation
- > Symptomatic relief of chronic intractable pain
- > Adjunctive treatment for the management of post-traumatic or post-surgical pain
EMS (Electrical Muscle Stimulation)
- > Relaxation of muscle spasm
- > Increasing local blood circulation
- > Muscle re-education
- > Prevention or retardation of disuse atrophy
- > Prevention of venous thrombosis of the calf muscles immediately after surgery
- > Maintaining or increase range of motion
Device Description
The Flex-MI is a combination EMS and interferential stimulation device which delivers nerve or muscle stimulation by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the intended treatment of patient. The stimulator has 2 output channels, accessed through jacks at the top of the housing, so that it may stimulate either 2 or 4 patient electrodes. The device is powered by 4.8V Ni- MH rechargeable battery pack. A patient compliance timer can memorize 60 sets of operation records; the total recordable time is 999 hours. Flex-MI is compatible and recommended for use with Everlife self-adhesive electrodes (K012463).
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K Number
K960200Device Name
INTROSTAT LEAD INTRODUCER
Manufacturer
Date Cleared
1996-07-02
(181 days)
Product Code
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
MSI, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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