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510(k) Data Aggregation
K Number
K042881Device Name
PMD-2000 INTERFERENTIAL STIMULATOR
Manufacturer
Date Cleared
2004-11-18
(30 days)
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
PHOENIX MEDICAL DEVICES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Interferential Current Mode: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post surgical and post traumatic pain.
Neuromuscular Stimulator Mode: Relaxation of muscle spasm, increasing local blood circulation, maintaining and increasing range of motion, preventing or retarding disuse atrophy, muscle re-education, and immediate post surgical stimulation of calf muscles to prevent venous thrombosis.
Device Description
The PMD-2000 Interferential Stimulator is a battery or AC wall adapter powered device intended for clinic, and outpatient use. Once prescribed by a physician it gives the clinician a variety of electrotherapy modes to treat a range of indications. The PMD-2000 is designed for clinician and patient ease of use and provides safe and effective dispensing of the desired electrotherapy treatment. The PMD-2000 incorporates the following features:
- Two independent stimulation channels, which provide true interferential current and neuromuscular stimulation.
- Continuous or pulsed stimulation. Various sweep and ramp times.
- Adjustable amplitude and frequency.
- Fifteen preset therapy protocols.
- Pause button to allow temporary suspension of treatment and a resume button to allow the resumption of treatment. When a treatment session is paused, the timer does not countdown. Upon resumption of treatment, the timer resumes its countdown and the amplitude (intensity) is reset to zero.
- Easy to connect, easy to handle, patient lead wire/cable assembly with a "one way" connector and color coded lead wires contribute to improved patient experience and improved therapy outcomes.
- Timed therapy sessions.
- Double A (AA) battery system accommodates standard alkaline, NiCad and Nickel Metal Hydride batteries.
- The PMD-2000 user interface incorporates a 16 character (8x2) Liquid Crystal Display (LCD) and tactile switches for menu navigation.
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