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510(k) Data Aggregation
K Number
K121305Device Name
STERLING MEDICAL IMPULSE 3 STIMULATOR
Date Cleared
2012-09-25
(147 days)
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
ARMSTRONG INDUSTRIES, INC. DHA MEDIQUIP INT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Interferential Stimulation (INF) is used for symptomatic relief and management of chronic (Iongterm) intractable pain and/or as an adjunctive treatment in the management of postsurgical and post-traumatic acute pain.
External electrical neuromuscular stimulation (NMES) using biphasic output is indicated as therapeutic adjunct for: prevention or retardation of muscle disuse atrophy; relaxation of muscle spasm; muscle reeducation; maintaining and increasing the range of motion; increasing local blood circulation and as immediate postsurgical stimulation of caff muscles to prevent venous thrombosis.
Transcutaneous Electrical Nerve Stimulation (TENS) is used for the symptomatic relief and management of chronic (long-term) intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain problems.
Device Description
The Impulse 3 is a portable two channel, battery operated combination electrical neuromuscular stimulator (NMES), interferential stimulator (INF), and transcutaneous electrical nerve stimulator (TENS) unit for pain control, and muscle stimulation. This device, supporting symmetric biphasic, pulsed sine, and asymmetrical biphasic waveforms can be used with the preprogrammed protocols or can be manually configured. A graphical display is provided to provide the user a verbose interface to assist in programming the configurable protocols.
The device is supplied with electrodes and electrode leads, non-replaceable batteries, wall adapter, instruction manual, and carrying case.
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K Number
K970847Device Name
IMPULSE HVG
Manufacturer
Date Cleared
1997-09-10
(187 days)
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
ARMSTRONG INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Impulse HVG Stimulator can be used to treat and provide therapeutic relief for the following indications:
- relaxation of muscle spasm
- prevention or retardation of disuse atrophy
- increasing local blood circulation, and
- maintaining or increasing range of motion
The Impulse HVG has the same intended medical uses as the listed predicate device (PGS 3000).
Device Description
Impulse HVG
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K Number
K953982Device Name
SIMPLEX TENS
Manufacturer
Date Cleared
1997-04-25
(611 days)
Product Code
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
ARMSTRONG INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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