(84 days)
Not Found
No
The description details a microprocessor-controlled electrotherapy device with pre-defined programs selected by the user. There is no mention of the device learning from data, adapting its parameters based on patient response, or using any form of AI/ML algorithms for program selection or stimulation adjustment. The "microprocessor controlled" aspect refers to standard digital control, not AI/ML.
Yes
The intended use clearly states that the device is for "re-educating muscles," "relaxation of muscle spasm," "increasing local blood circulation," "retarding or preventing disuse atrophy," and "maintaining or increasing range of motion," which are all therapeutic purposes.
No
The device is an electrotherapy device used for neuromuscular electrical stimulation (NMES) for therapeutic purposes like re-educating muscles, relaxation of muscle spasm, and increasing local blood circulation. It provides treatment rather than diagnosing a condition.
No
The device description explicitly lists multiple hardware components including a stimulator, wire set, electrodes, charger, belt clip, and carrying case. While it mentions supporting software for the user interface, the core functionality and delivery of the therapy rely on the physical hardware.
Based on the provided information, the Compex® Rehab device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is an "adjunctive multifunction electrotherapy device" used for neuromuscular electrical stimulation (NMES) to treat conditions like re-educating muscles, relaxing muscle spasms, increasing blood circulation, preventing disuse atrophy, and maintaining/increasing range of motion. These are all therapeutic applications performed on the patient's body.
- Device Description: The description details a stimulator, wires, electrodes, charger, and user interface. These components are designed to deliver electrical stimulation to the patient's muscles.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body. IVD devices are specifically designed for such in vitro analysis to provide information about a patient's health.
The Compex® Rehab is a therapeutic device used for physical rehabilitation, not a diagnostic device used for testing biological samples.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
IPF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Hip or Knee (muscle groups)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Globus Genesy 1100 Electro-Stimulator (K071431)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Section 4: 510(k) Summary of Safety and Effectiveness
Date of Summary Preparation: May 5, 2009 JUN - 1 2009 Contact: Michael Treas Director, Regulatory Affairs Chattanooga Group Manufacturer: 4717 Adams Rd Hixson, TN 37343 Phone: (423) 870-7207 Fax: (423) 870-7404 Email: michael treas(@chattgroup.com
| Product | Product Code | Regulation and Classification Name |
|---|---|---|
| Compex® Rehab | IPF | stimulator, muscle, powered (21 CFR 890.5850) |
Predicate Device:
Globus Genesy 1100 Electro-Stimulator (K071431) with the following intended use:
The Globus Genesy 1100 Electro-stimulator should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. It is intended to be used with NMES, Russian, TENS and Interferential Premodulated Currents (IFC) to obtain the following:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- 피 Muscle re-education
- 트 Maintaining or increasing range of motion
Additional Indications for Microcurrent, Interferential Premodulated Currents (IFC), NMES and TENS waveforms:
- Management of chronic, intractable pain 제
- 트 Post-traumatic acute pain
- 트 Post-surgical acute pain
- 미 Immediate post-surgical stimulation of muscles to prevent venous thrombosis
Indications for Use:
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:
රි
1
- Re-educating muscles
- . Relaxation of muscle spasm
- . Increasing local blood circulation
- . Retarding or preventing disuse atrophy
- Maintaining or increasing range of motion
Product Description:
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. .
Figure 1 Stimulator
Image /page/1/Picture/23 description: The image shows a Compex Rehab device with several labeled parts. The labels include A, B, C, D, E, and F, which point to different buttons and ports on the device. There are also numbers 1, 2, 3, and 4 indicating the ports at the bottom of the device.
Image /page/1/Figure/24 description: The image shows a gray object with two labels, H and G, pointing to different locations on the object. Label H is located near the top of the object, while label G is located lower down. The object appears to be a container or device with a rounded shape. The labels are positioned to indicate specific points or features on the object's surface.
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A On/Off button
B "i" button used to increase stimulation energies in several channels simultaneously
C Sockets for the 4 stimulation cables
D Stimulation cables
Channel 1 = blue
Channel 2 = green
Channel 3 = vellow
Channel 4 = red
E +/- buttons for the 4 stimulation channels
- F Socket for the charger (slide the red cover to the right to free the charger connector while inserting the charger pin)
- G Rechargeable battery compartment
- H Belt clip socket
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
3
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.
Program Descriptions:
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 �
1. Massage
The Compex Rehab Massage program is intended to relax muscle spasm, reduce the muscular spasticity, and enable the target muscles to contract effectively.
This program is recommended for use as needed before and after the surgery as prescribed by your medical professionals.
2. Endurance
The Compex Rehab Endurance program focuses on activating an average medium working level on muscle fibers. This working level is maintained over a long time period (25 minutes per session). The Endurance program particularly activates the aerobic metabolism of the fibers during the stimulation session. The purpose is to increase the time for the muscle to maintain a medium level of working power or the average power level for extended periods of time.
This program is recommended for use before and after the surgery as prescribed by your medical professionals.
3. Strength
The Compex Rehab Strength program imposes a high and instantaneous power working level on muscle fibers. These contractions are separated by long periods of rest. The result is an average medium power working level (+ 20 minutes). This program is intended to increase the maximum strength of muscle isometric contraction. This program targets the muscle fibers that are typically afflicted with immediate atrophy after injury or/and surgery.
This program is recommended for use only after having completed at least 10 sessions of previous the Endurance program as prescribed by your medical professionals.
Substantial Equivalence: When compared to the predicated device, Globus Gensy 1100 Electro-Stimulator, the Compex® Rehab has the same intended use, output mode (NMES), NMES output parameters, and energy delivered. In addition, 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, Compex® Rehab is substantially equivalent to the predicate marketed device, Globus Gensy 1100 Electro-Stimulator.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a stylized eagle with three stripes representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Chattanooga Group % DJO. LLC Ms. Nora C.R. York Vice President of Global Regulatory Affairs 1430 Decision Street Vista, California 92081
Re: K090632
Trade Name: Compex® Rehab Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF Dated: May 5, 2009 Received: May 9, 2008
Dear Ms. York:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
JUN - 1 2009
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2- Ms. Nora C.R. York
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
Device Name: Compex® Rehab
510(k) Number if known:
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 .
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Dislon Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090632