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510(k) Data Aggregation
K Number
K221958Device Name
Flex-MI
Manufacturer
EMSI, Inc.
Date Cleared
2022-10-21
(108 days)
Product Code
IPF, LIH
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
EMSI, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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
K140467Device Name
FLEX-MT +
Manufacturer
EMSI
Date Cleared
2014-10-07
(225 days)
Product Code
IPF, GZJ
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
EMSI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
As prescribed by a physician for the following:
TENS- Transcutaneous Nerve Stimulation
- Symptomatic relief of chronic intractable pain .
- . Post traumatic and post surgical pain relief
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-MT + is a combination TENS and EMS 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 700 mAh 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.
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K Number
K102202Device Name
GS 3000
Manufacturer
EMSI
Date Cleared
2010-11-23
(111 days)
Product Code
IPF
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
EMSI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
As prescribed by a physician for the following:
Relaxation of muscle spasm
Increasing local blood circulation
Maintaining or increasing range of motion
Preventing or retarding disuse atrophy
Muscle re-education
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
Device Description
The GS 3000 is a High Voltage Pulsed Galvanic Current (HVPGC) Stimulator which delivers stimulation by applying an electrical current to electrodes, which are attached on the patient's skin. The device has a twin peak monophasic waveform with a 5 usec fixed duration. The current Amplitude is adjustable from 0-350 Volts (0~190V Max @ 500ohm resistance), with an adjustable pulse frequency range from 2-100 cycles per second.
The GS 3000 is a single channel device, with the option to set the active electrodes (treatment electrode) to either positive or negative polarity in relation to the dispersive electrode (closes patient circuit) and alternating or synchronous treatment mode selection. The device is powered by a 9 volt battery.
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K Number
K090889Device Name
EMSI GARMENT ELECTRODES
Manufacturer
EMSI
Date Cleared
2009-12-04
(248 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
EMSI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Electrodes intended for use as reusable (by a single patient), cutaneous, flexible, conductive garment/fabric electrodes for interface between electrical stimulators such as interferential devices, galvanic devices, TENS, etc. and a patient's skin for the delivery of electrical stimulation.
Device Description
The EMSI Garment Electrodes are a cloth type device weft knitted of a continuous fiber made up of 77% Nylon and 23% Silver. Each device is flexible, and is available in a range of sizes to ensure good patient contact. A male snap connector is placed within the fabric weave and is connected via the female snap connector to a short lead wire, The lead wire has a female pin connection at the distal end which accepts the lead wire connection from the stimulator. The entire fabric is made up of conductive material to provide uniform current distribution when connected to a stimulator.
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K Number
K090717Device Name
FLEX-TENS
Manufacturer
EMSI
Date Cleared
2009-05-08
(51 days)
Product Code
GZJ
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
EMSI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K083030Device Name
TENS-EMS-14
Manufacturer
EMSI
Date Cleared
2009-02-05
(118 days)
Product Code
GZJ, IPF
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
EMSI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TENS- Transcutaneous Nerve Stimulation
- . Symptomatic relief of chronic intractable pain
- Post traumatic and post surgical pain relief .
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 TENS-EMS-14 is a combination TENS and EMS 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 AA batteries. A patient compliance timer can memorize 60 sets of operation records; the total recordable time is 999 hours.
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K Number
K071869Device Name
TENS/IF 14
Manufacturer
EMSI
Date Cleared
2008-03-07
(245 days)
Product Code
GZJ, LIH
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
EMSI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Symptomatic relief of chronic intractable pain
Adjunctive treatment for the management of post-traumatic or post-surgical pain
Device Description
The TENS/IF 14 is a combination TENS and Interferential device which delivers nerve 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 may be powered by either 4 AA batteries or by an AC adapter, that when plugged into a wall outlet provides 6 VDC to the unit. A patient compliance timer can memorize 60 sets of operation records; the total record time is 999 hours.
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