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510(k) Data Aggregation
K Number
K153559Device Name
OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System
Manufacturer
Accelerated Care Plus (ACP)
Date Cleared
2016-08-26
(256 days)
Product Code
IMG, GZJ, IPF
Regulation Number
890.5860Why did this record match?
Applicant Name (Manufacturer) :
Accelerated Care Plus (ACP)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OmniVersa™ Multi Modality Therapy and Omnistim® FX2 Professional Therapy Systems by ACP use the Omnistim® FX2 Stimulator for the following indications for use:
- · Relaxation of muscle spasms
- · Re-education of muscle
- · Prevention or retardation of disuse atrophy
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Increases local circulation
- · Maintains or increases range of motion
Stimulator waveforms: IFC, LVPC, and VMS:
· Symptomatic relief and management of chronic intractable pain and as an adjunctive treatment of acute pain, post-surgical pain and pain associated with post-traumatic injury.
Electrical muscle stimulator devices should be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.
The OmniVersa™ Multi-Modality Therapy System also uses Omnisound® Ultrasound Transducer(s) for the following indications for use:
- Relieves pain
- · Decreases joint stiffness and contractures
- · Reduction of muscle spasm
- · Increases local circulation
- · Relief of pain, muscle spasms, and joint contractures that may be associated with: adhesive capsultiis, bursitis with slight calcification, myositis, soft tissue injuries, shortened tendons due to past injuries and scar tissues
- · Relief of sub-chronic, chronic pain and joint contractures resular tightness, capsular scaring
Device Description
Not Found
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K Number
K153456Device Name
Megapulse III Shortwave Diathermy
Manufacturer
Accelerated Care Plus
Date Cleared
2016-06-14
(196 days)
Product Code
IMJ
Regulation Number
890.5290Why did this record match?
Applicant Name (Manufacturer) :
Accelerated Care Plus
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diathermy is used therapeutically to increase the temperature of tissues. It is generally accepted that heat produces the following desirable therapeutic effects:
- · Relieves pain
- · Increases the extensibility of collagen tissues
- · Decreases joint stiffness
- · Relieves muscle spasm
- Increases local blood flow
Megapulse Shortwave Diathermy system is indicated for use in the following conditions or applications:
- · Disorders of the musculoskeletal system
- o Muscle spasm
- o Joint stiffness
- o Joint contractures
- · Chronic inflammatory or infective conditions
- o Tenosynovitis
- o Bursitis
- o Synovitis
- o Chronic inflammatory pelvic diseases
Device Description
Not Found
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K Number
K093600Device Name
OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM
Manufacturer
ACCELERATED CARE PLUS
Date Cleared
2009-12-04
(14 days)
Product Code
KPI
Regulation Number
876.5320Why did this record match?
Applicant Name (Manufacturer) :
ACCELERATED CARE PLUS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A non-implanted electrical stimulator for urinary incontinence is intended to retrain the urinary continence mechanisms by way of electrical stimulation applied to the pelvic floor musculature and surrounding structures. Typically, these devices are indicated for use in females for treatment of stress incontinence, urge incontinence, or mixed incontinence (a combination of stress and urge incontinence).
Intended for use in acute and ongoing treatment of urinary incontinence in cases where the following results may improve urinary control: Improvement of urethral sphincter closure, strengthening of pelvic floor muscles, Inhibition of the detrusor muscle through reflexive mechanisms.
Device Description
Non-implanted electrical stimulator for urinary incontinence
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K Number
K060191Device Name
ACP OMNIPAD LIGHT THERAPY SYSTEM & ACP OMNIPAD 500 CONTROL UNIT
Manufacturer
ACCELERATED CARE PLUS CORP.
Date Cleared
2006-07-12
(168 days)
Product Code
ILY
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
ACCELERATED CARE PLUS CORP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended to for use to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pains, minor arthritis pain and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue and to temporarily increase local blood circulation
Device Description
OmniProbe Infrared Lamp, OmniProbe 500 Infrared Lamp Control Unit
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