Search Results
Found 1 results
510(k) Data Aggregation
K Number
K041390Device Name
DIAMOND MEDISTIM
Manufacturer
Date Cleared
2005-02-09
(260 days)
Product Code
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
DIAMOND SYSTEMS USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
1. Relaxation of muscle spasms;
2. Prevention or retardation of disuse atrophy;
3. Increasing local blood circulation;
4. Muscle re-education;
5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and
6. Maintaining or increasing range of motion.
When the device is used in a manner that delivers continuous, uninterrupted pulses, it is indicated only for the relaxation of muscle spasms. The Variable Stim output mode delivers continuous, uninterrupted pulses. The Auto Stim output mode delivers bursts of pulses that are interrupted with 1 second "off" periods.
Device Description
The Diamond MediStim is a powered muscle stimulator, which is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. The machine uses 2 modes: VARIABLE STIM and AUTO STIM. The device has CE approval.
Ask a Question
Ask a specific question about this device
Page 1 of 1