(322 days)
No
The description details a programmable muscle stimulator with pre-stored programs selected via a menu and controlled by a microprocessor. There is no mention of adaptive algorithms, learning from data, or any other characteristics typically associated with AI/ML. The device operates based on pre-defined parameters for each program.
No.
The intended use explicitly states that the devices are "not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind."
No
Explanation: The "Intended Use/Indications for Use" section explicitly states that the device is "not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind" and is for stimulating healthy muscles to "improve or facilitate muscle performance." This indicates it is not used for diagnosis.
No
The device description explicitly details hardware components such as a constant-current generator, transformer, and micro-processor, which are integral to its function as a muscle stimulator.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "stimulate healthy muscles in order to improve or facilitate muscle performance." This is a physical intervention, not a diagnostic test performed on samples from the human body.
- Device Description: The device is a muscle stimulator that applies electrical impulses to muscles. This is a therapeutic or performance-enhancing device, not a diagnostic one.
- Lack of Diagnostic Activity: The description focuses on how the device works to stimulate muscles and improve performance. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a medical condition.
- Contraindication: The contraindication is for use on injured or ailing muscles, further emphasizing its focus on healthy muscle performance rather than diagnosing or treating medical conditions.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Globus Premium Sport and the Globus Premium Fitness Muscle Stimulators are intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Globus Premium Sport and Globus Premium Fitness Muscle Stimulators are not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the Globus Premium training programs are designed for injured or ailing muscles and their use on such muscles is contraindicated
Product codes
NGX
Device Description
The Globus Premium Sport and Fitness Devices are programmable muscle stimulators. Each device in the family comes with a menu to navigate between different stimulation programs. The Stimulation Programs have been subdivided in menus and submenus to facilitate use for various types of uses.
The Globus Premium Stimulators electrical impulses trigger action potentials on motor neurons of motor nerves. These excitations are transmitted via the motor end-plate to the muscle fibers, where they generate mechanical responses that result in muscle work. Depending on the electrical impulse parameters (current intensity, frequency, shape of the impulse, duration of contraction, duration of rest, total session duration) different types of muscle work can be performed. This work is able to improve or facilitate muscle performance, and may therefore be considered a muscle training technique.
The Globus Premium family models include the Globus Premium Sport and the Globus Premium Fitness. The configurations differ in the navigation menus that allow the user to select the pre-stored electrostimulation programs offered, but offer technically-identical electrostimulations. The core of the Globus Premium device is a constant-current generator; a transformer guarantees insulation between outlet current utilized for the battery charger, and the circuits utilized for stimulation current. A micro-processor elaborates the menu selections and drives the constant-current generator that originates the electrical impulses for the electrostimulation. This is accomplished according to the parameters stored for that particular program. The user can regulate the current continuously from 0-120 mA.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary
for
Globus Premium Sport and Fitness Muscle Stimulators
SPONSOR 1.
Domino S.r.l. Via San Felice, 4 31020 San Vendemiano (TV) Italy
Contact Person: Giovanni Ciriani Telephone: 860-539-1309
Date Prepared: March 26, 2006
DEVICE NAME 2.
Proprietary Name: Globus Premium Sport and Fitness Muscle Stimulator Common/Usual Name: Electric Muscle Stimulator Classification Name: Powered muscle stimulator
PREDICATE DEVICES 3.
Compex Sport Stimulator Device K011880
4. DEVICE DESCRIPTION
The Globus Premium Sport and Fitness Devices are programmable muscle stimulators. Each device in the family comes with a menu to navigate between different stimulation programs. The Stimulation Programs have been subdivided in menus and submenus to facilitate use for various types of uses.
The Globus Premium Stimulators electrical impulses trigger action potentials on motor neurons of motor nerves. These excitations are transmitted via the motor end-plate to the muscle fibers, where they generate mechanical responses that result in muscle work. Depending on the electrical impulse parameters (current intensity, frequency, shape of the impulse, duration of contraction, duration of rest, total session duration) different types of muscle work can be performed. This
Domino s.r.l. Additional Information - K061632
March 26, 200
1
1
work is able to improve or facilitate muscle performance, and may therefore be considered a muscle training technique.
The Globus Premium family models include the Globus Premium Sport and the Globus Premium Fitness. The configurations differ in the navigation menus that allow the user to select the pre-stored electrostimulation programs offered, but offer technically-identical electrostimulations. The core of the Globus Premium device is a constant-current generator; a transformer guarantees insulation between outlet current utilized for the battery charger, and the circuits utilized for stimulation current. A micro-processor elaborates the menu selections and drives the constant-current generator that originates the electrical impulses for the electrostimulation. This is accomplished according to the parameters stored for that particular program. The user can regulate the current continuously from 0-120 mA.
5. INTENDED USE
The Globus Premium Sport and Fitness Muscle Stimulators are intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Globus Premium Sport and Fitness family of muscle stimulation devices are not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the Globus Premium training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The Domino S.r.l. Globus Premium Sport and Fitness device and the Compex Sport Stimulator are similar in design and function. All of the devices offer a biphasic waveform, rectangular, symmetrical and compensated and a beat frequency in the range of 1-120 Hz. The Globus and predicate devices are software driven powered muscle stimulator units that provide the user with a treatment program for healthy muscles.
The Globus Premium and the Compex Sport devices are all very similar in design configuration, technical characteristics and performance. The Globus Premium devices maximum current output and maximum electric charge are very similar to the predicate device. The only significant difference between the Globus Premium Sport and Fitness and the predicate device is that the Globus Premium devices can perform stimulation on different muscular groups of the same subject.
2
This is accomplished by providing two different stimulation currents on different channels e.g. while stimulating the legs, it can also stimulate arms at the same time. The proposed Globus Premium Sport and Fitness device architecture, safety features and isolation modes are substantially similar to the predicate device.
March 26, 2007
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Domino S.r.l. % Globus Sport and Health Technologies, LLC Mr. Giovanni M. Ciriani, B.A. Managing Partner 18 Eustace Drive West Hartford, Connecticut 06110
APR 3 0 2007
Re: K061632
Trade/Device Name: Globus Premium Sport and Fitness Muscle Stimulators Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: NGX Dated: March 26, 2007 Received: March 28, 2007
Dear Mr. Ciriani:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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); 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 - Mr. Giovanni M. Ciriani, B.A.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number: K061632
Device Name: Globus Premium Sport and Fitness Muscle Stimulators
Indications For Use:
The Globus Premium Sport and the Globus Premium Fitness Muscle Stimulators are intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Globus Premium Sport and Globus Premium Fitness Muscle Stimulators are not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the Globus Premium training programs are designed for injured or ailing muscles and their use on such muscles is contraindicated
| Prescription Use | AND/OR | Over-the-Counter Use | X |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | L061632 |
|---|---|
| --------------- | --------- |
| 1. Domino S.r.l. 510(k) | March 26, 2006 | 2. |
|---|---|---|
| Globus Premium Muscle Stimulator |