(84 days)
The Compex® Rehab is an adjunctive multifunction electrotherapy device with various treatment modes that allow for neuromuscular electrical stimulation (NMES).
The Compex® Rehab is indicated for the following conditions:
- Re-educating muscles
- Relaxation of muscle spasm
- Increasing local blood circulation
- Retarding or preventing disuse atrophy
- Maintaining or increasing range of motion
The Compex® Rehab system consists of the following components:
- 1x Stimulator
- 1x Wire Set
- 2x Small Performance Snap Electrode package
- 2x Large Performance Snap Electrode package
- 1x Fast Charger
- 1x Belt clip
- 1x User Manual
These components are packaged together in a carrying case.
The stimulator is a microprocessor controlled 4 channels neuro-muscular electro-stimulator. The stimulator drives each output channel independently based upon the parameters pre-defined for a program selected by the user. The user operates the device through a User Interface (UI) consisting of a graphic LCD, keypad controls and supporting software. The User Interface is made up of four (4) different menus that allow the following functions:
- Options Menu: set up the device, e.g. operating languages, LCD contrast, LCD backlight, Audio output level;
- Body Area Menu: select a desired muscle group, e.g. Shoulder, Hip or Knee;
- Treatments Menu: select a preset program, e.g. Massage, Endurance, Strength;
- Stimulation Menu: select lead wire channels and adjust the stimulation intensities.
The stimulator is housed in a molded portable plastic case with a viewable LCD display, an accessible keypad, and accessible battery storage compartment. The case shape is rectangular.
The LCD is located on the upper half of the rectangular face of the device, above the keypad. The display is a graphic display capable of showing alpha numeric characters (including lower case characters), most standard ASCII symbols, and graphics appropriate to assist the user in selecting a desirable program. The LCD is used to display system information to the user.
The device is equipped with a keypad composed of push buttons which are located below the LCD. The function for each button is defined by a symbol on the LCD corresponding to the button immediately below it.
Power for the device is provided from a 4.8 Volt rechargeable Ni-MH battery pack. The power source is housed behind an operator access panel on the back of the device cover.
Each of the four (4) lead wires will connect the output of the stimulator to each of the electrodes for each respective output channel. Each lead wire will be connected to the stimulator using a high friction, and forced fitting, mechanically shielded connection is a mechanically shielded snap connector (compliant with the 21 CFR §898.12 PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES).
Each electrode set requires a lead/connector assembly. The electrode connector is compatible with the cable connector. Up to four Active/Passive sets of electrodes are required.
The electrodes (non sterile electrodes) are applied parts which conform to the BF classification of the IEC60601-1 standard and the particular safety standard for nerves and muscles stimulators: IEC60601-2-10.
For patient safety, the device is designed to prohibit use of the device on patients while the battery is being charged. A red plastic cover inside the charging socket blocks the charger pin when the lead wires are still connected to the device. Unplugging the lead wire cables unlocks the red plastic cover and allows the charger pin plug in the charging socket. Connecting a charger to the stimulator automatically starts the charging procedure. A battery symbol on the LCD indicates the status of the battery charging.
The battery pack of the stimulator is charged by a switching adapter which supplies an output current of 1.4 A +/-100 mA and an output voltage of 9V DC +/- 2%. The primary plug is an American 2 pin AC type able to handle input voltage from 90 to 240V AC and at a maximum input current of 0.5 A. The secondary plug on the stimulator is a straight jack plug with the following dimensions, outer diameter: 3.5 mm, inner diameter: 1.3 mm and length: 9 mm. The charger has a short circuit protection. Maximum dimensions of the charger are 72 x 52 x 35 mm.
The Compex Rehab provides three muscle stimulation training programs which correspond to target muscle groups (Shoulder, Knee, Hip) of the patient intended for use during rehabilitation. These rehabilitation programs are:
- Massage
- Endurance
- Strength
This is a marketing application for a class II medical device, a powered muscle stimulator. The information provided does not describe a clinical study or acceptance criteria. It states that Compex Rehab is substantially equivalent to a predicate device, Globus Genesy 1100 Electro-Stimulator (K071431), because it has the same intended use, output mode (NMES), NMES output parameters, and energy delivered. It further claims that "any differences in their technological characteristics are explained to demonstrate in this submission that these differences do not raise any new questions of safety or effectiveness."
Therefore, for this submission, no specific acceptance criteria or study details regarding performance metrics, sample sizes, ground truth establishment, or expert involvement are present. The basis for substantial equivalence relies on the comparison to the predicate device's existing regulatory clearance.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).