Search Results
Found 1 results
510(k) Data Aggregation
K Number
K102524Device Name
FUTURA
Manufacturer
DR. OLIVER WENKER, M.D., M.B.A.
Date Cleared
2011-11-03
(427 days)
Product Code
IMG
Regulation Number
890.5860Why did this record match?
Applicant Name (Manufacturer) :
DR. OLIVER WENKER, M.D., M.B.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MUSCLE STIMULATOR
INDICATIONS FOR 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
6. Maintaining or increasing range of motion
Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.
ULTRASOUND
INDICATIONS FOR USE:
Application of deep heat for:
1. Temporary relief of minor pain
2. Muscle spasm relief
3. Joint contracture relief
Not for treatment of malignancies. Not for use on the face.
Device Description
The Futura Pro (US Specification) is a 10 channel Electronic Muscle Stimulator system with a diathermic ultrasound attachment.
The main muscle stimulation part consists of a main control unit which powers and controls a separate stimulator that repetitively contracts skeletal muscles by applying transcutaneous electrical pulses to areas of the body that require therapy for the indicated conditions. These pulses for muscle stimulation are applied via self adhesive electrodes applied on the skin.
The ultrasound attachment is also powered by the main control unit. The diathermic ultrasound signal is delivered via an acoustic coupling gel. The ultrasound applicator has all the necessary controls (on/off amplitude) in the handset and derives only a time controlled power source from the main control unit.
Set programs, with predetermined parameters, are selectable by the operator. On screen instructions guide the user, displaying numbered programs, indication of intensity levels, adjustments, and treatment use. The output leads have indicator LEDs identifying each output as the electrodes are positioned and the intensity adjusted.
The system is powered either internally from a 12V rechargeable sealed battery within the main control unit or via an external12VDC power supply.
Not part of this submission: Electrodes and Conductive gel. Dr. Wenker shall purchase and distribute the FDA-cleared electrodes and coupling gel, which have been specified by Ultratone Scientific Instruments to ensure proper operation of their equipment. Initially, Ultratone Scientific Instruments has specified electrodes and coupling gel from the respective manufacturers, Axelgaard and Parker. Dr. Wenker shall be purchasing and distributing these two items separately.
The stimulator contains safe-start electronic output interlock circuits to ensure stimulation is not suddenly applied to the patient at turn on. The stimulation outputs can subsequently be adjusted by a master output control.
Ask a Question
Page 1 of 1