ACCELERATED CARE PLUS CORP

Address:4999 Aircenter Cir.,RENO,NV,89502,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Stimulator, Muscle, Powered (IPF) (4) Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat (IMJ) (2) Stimulator, Nerve, Transcutaneous, For Pain Relief (GZJ) (2) Lamp, Infrared, Therapeutic Heating (ILY) (1) Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat (IMG) (1)

Premarket Exempt

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Omnisound 3000E - 00858703006009 Catalog Number :

Device Description : Welcome to the Omnisound® 3000 Pro, the system that redefines therapeutic ultras Welcome to the Omnisound® 3000 Pro, the system that redefines therapeutic ultrasound. While conceiving anddesigning the Omnisound® 3000 Pro, ACP set out to overcome the limitations of ordinary ultrasound devices.Here are just a few of the functions we developed that make the Omnisound® 3000 Pro truly the future ofultrasound therapy:• Controlled Depth of Penetration - The Omnisound® 3000 Pro enables you to treat soft tissue injuries,superficially with 3 MHz and instantly at the push of a button, treat deeper injuries with 1 MHz - withoutswitching transducers.• Two Transducer Sizes - Our 2cm2 and 5cm2 heads offer optimum flexibility in treatment and are automaticallyenabled as you change from one to the other.• Combination Therapy - Interconnect port allows combination therapy with the Omnistim® family ofelectrostimulators.• Excellent BNR and ERA - Our superior BNR and ERA makes for highly uniform and comfortableapplications.

Device Class : 2

Duns Number: 828331616

Premarket Exempt : No

Product Code : IMG

Prescription Use : Yes

Device Count : 1

Omnistim 500 Pro - 00858703006016 Catalog Number :

Device Description : The Omnistim® 500 Pro is designed to provide Interferential Current Therapy (IFC The Omnistim® 500 Pro is designed to provide Interferential Current Therapy (IFC), Medium Frequency AlternatingCurrents (MFAC), Low Voltage Pulsed Current (LVPC) and High Voltage Pulsed Current Therapy (HVPC). Itstwo separate generators produce medium frequency (2000, 2500, 4000 or 5000 Hz) alternating current in continuousor modulated modes. Two isolated output circuits with independent intensity controls are provided.The Omnistim® 500 Pro MFAC and LVPC modes with fully adjustable ON and OFF times and ON and OFF rampsprovides a wide variety of uses for muscle re-education and muscle spasm reduction protocols for innervatedmuscle.The Omnistim® 500 Pro provides High Voltage Pulsed Current (HVPC) on one channel. Continuous or surgedoperation with fully adjustable ON and OFF times and ramps allow applications of HVPC therapy. Increasingcirculation, pain control and muscle re-ed can be set up in this mode.

Device Class :

Duns Number: 828331616

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

Omnistim FX2 Pro - 00858703006023 Catalog Number :

Device Description : The Omnistim® FX2 Pro Sport provides Patterned Electrical Neuromuscular Stimulat The Omnistim® FX2 Pro Sport provides Patterned Electrical Neuromuscular Stimulation (PENS), which is a form ofgentle stimulation that replicates the correct firing patterns of muscles (agonist and antagonist or reciprocal musclepairs) in triphasic (ballistic), biphasic (reciprocal), or functional patterns. This approach to neuro re-ed provides ahigh intensity, precisely timed sensory input, which duplicates the firing activity of sensory neurons and musclestretch receptors during voluntary activity.

Device Class :

Duns Number: 828331616

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

Omnistim FX2 Pro Sport - 00858703006030 Catalog Number :

Device Description : The Omnistim® FX2 Pro provides Patterned Electrical Neuromuscular Stimulation (P The Omnistim® FX2 Pro provides Patterned Electrical Neuromuscular Stimulation (PENS), which is a form ofstimulation that replicates the correct firing patterns of muscles (agonist and antagonist or reciprocal muscle pairs) intriphasic (ballistic), biphasic (reciprocal), or functional patterns. This approach to neuro re-ed provides a highintensity, precisely timed sensory input, which duplicates the firing activity of sensory neurons and muscle stretchreceptors during voluntary activity.

Device Class :

Duns Number: 828331616

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

Neuroprobe 500 Pro - 00858703006054 Catalog Number :

Device Description : The Neuroprobe® 500 Pro gives the clinician the option of using any combination The Neuroprobe® 500 Pro gives the clinician the option of using any combination of an Estim probe, Interferential Currentin bipolar or quadripolar modes, or Monochromatic Infrared Therapy to reduce pain and increase circulation.Flexible neoprene pads deliver heat and Infrared therapy through multiple clusters of infrared and red visible superluminous diodes (SLD).The Neuroprobe® 500 Pro’s optional probe with fully adjustable parameters provides a wide variety of uses for painmanagement with trigger point stimulation for pain control.The Neuroprobe® 500 Pro provides a nerve block mode through treatment pads with high output capable of sensorynerve block, or through the optional probe to produce local trigger point anesthesia.

Device Class :

Duns Number: 828331616

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

Omnipad Light Therapy, Dual 5x7 Pads - 00858703006061 Catalog Number :

Device Description : Infrared lamp for therapeutic healing

Device Class :

Duns Number: 828331616

Premarket Exempt : No

Product Code : ILY

Prescription Use : No

Device Count : 1

Megapulse II - 00858703006078 Catalog Number :

Device Description : Shortwave Diathermy for use in applying therapeutic deep heat

Device Class : 2

Duns Number: 828331616

Premarket Exempt : No

Product Code : IMJ

Prescription Use : Yes

Device Count : 1

Megapulse III/OmniSWD - 00858703006085 Catalog Number :

Device Description : Shortwave Diathermy for the use of applying therapeutic deep heat

Device Class : 2

Duns Number: 828331616

Premarket Exempt : No

Product Code : IMJ

Prescription Use : Yes

Device Count : 1

Synchrony FX2 Portable - 00858703006092 Catalog Number :

Device Description : Powered muscle stimulator

Device Class : 2

Duns Number: 828331616

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

Omnistim FX2 Portable - 00858703006108 Catalog Number :

Device Description : Transcutaneous Electrical Nerve Stimulator for pain

Device Class : 2

Duns Number: 828331616

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

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