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510(k) Data Aggregation
K Number
K040121Device Name
DERMAWAVE 5000 COMBI MAX SYSTEM
Manufacturer
Date Cleared
2004-03-17
(57 days)
Regulation Number
890.5860Why did this record match?
Applicant Name (Manufacturer) :
DERMAWAVE, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Stimulation, relaxing, and/or repeatedly contracting muscles by passing electrical currents through electrodes contacting the affected body area in the medical specialties of physical medicine, general and plastic surgery and neurology and/or for use in applying therapeutic deep heat for selected medical conditions such as relief of pain, muscle spasms and joint contractures in the medical specialty of physical medicine.
The indications of the DermaWave 5000 Combi Max System also include the treatment and relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, maintaining or increasing range of motion, immediate postsurgical stimulation of calf rnuscles to prevent venous thrombosis, symptomatic relief of chronic intractable pain, management of pain associated with post-traumatic or post-operative conditions using electrical stimulation and are indicated for the application of therapeutic deep heat for the treatment of selected medical conditions such as relief of pain, muscle spasms and joint contractures, relief of pain muscle spasms and joint contractures that may be associated with adhesive capsulitis, bursitis with slight calcification, myositis, soft tissue injuries, shortened tendons due to past injuries and scar tissucs, relief of chronic and sub-chronic pain and joint contractures resulting from capsular tightness and capsular scarring using ultrasound.
The DermaWave 5000 Combi Max System is also indicated for use in providing topical heating for temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.
Device Description
The DermaWave 5000 Combi Max System is comprised of the following main components:
- A system console including software and control electronics. .
- A control and display panel. .
- · Delivery device accessories including patient cables and electrodes, ultrasound cables, soundheads, and infrared heating accessories.
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