(121 days)
Not Found
No
The description details a programmable electro stimulator controlled by a microprocessor that elaborates menu selections and drives a constant-current generator based on stored parameters. There is no mention of AI, ML, or any adaptive or learning algorithms. The functionality described is based on pre-programmed parameters and user input, not data-driven learning or inference.
Yes
The device is intended for the "treatment of medical diseases and conditions" by providing therapies such as muscle spasm relaxation, prevention of disuse atrophy, and pain management.
No
The document describes the device as an electrostimulator used for therapy and symptom management (e.g., relaxation of muscle spasms, pain management), not for detecting or diagnosing medical conditions.
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 an electro-stimulator.
Based on the provided text, the Globus Genesy 1100 Electro-stimulator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. The Globus Genesy device, as described, directly applies electrical stimulation to the body for therapeutic purposes.
- The intended use and device description clearly outline its function as an electro-stimulator for muscle and nerve therapy. It focuses on applying electrical currents to the body to achieve therapeutic effects like muscle relaxation, pain management, and improved range of motion.
- There is no mention of analyzing biological specimens or providing diagnostic information based on such analysis.
Therefore, the Globus Genesy 1100 Electro-stimulator falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Globus Genesy Stimulator is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. It is intended to be used for therapy that adopts NMES, Russian, TENS, Premodulated Currents (IFC), and Microcurrent, waveforms.
The Globus Genesy is not intended to be used as an over-the-counter (OTC) device.
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 for therapies employing NMES, Russian, and Premodulated Currents (IFC) to obtain the following:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Additional Indications for Microcurrent, Premodulated Currents (IFC), NMES and TENS waveforms:
- Management of chronic, intractable pain
- Post-traumatic acute pain
- Post-surgical acute pain
Product codes
IPF, GZJ, and LIH
Device Description
The Globus Genesy Device is a programmable electro stimulator with multiple uses: Powered Muscle Stimulators, Transcutaneous Electrical Nerve Stimulator. Premodulated Current Therapy Stimulator, and Microcurrent Therapy Stimulator.
Each device in the family comes with a menu to select different stimulation The Stimulation Programs have been subdivided in menus and programs. submenus to facilitate use for various types of uses. The user can create and store protocols in the device for subsequent recall, and can store them and manipulate them in a PC for labeling and stimulation parameter changes.
The Globus Genesy electrical impulses trigger excitations that are transmitted to the muscle fibers, where they generate mechanical responses that result in muscle work. This work is used for muscle and range-of-motion rehabilitation therapies.
They also interact with the mechanism of pain generation and transmission in the nerve fibers; other stimulation currents interact directly with the affected body part to obtain the effect desired by the physician or licensed practitioner.
The core of the Globus Genesy 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
medical supervision
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 Genesy Electro-Stimulator
SEP 2 1 2007
1. SPONSOR
Domino S.r.l. Via San Felice, 4 31020 San Vendemiano (TV) Italy
Contact Person: Giovanni Ciriani 860-539-1309 Telephone:
Date Prepared: Sep 01, 2007
2. DEVICE NAME
| Proprietary Name: | Globus Genesy Electro-Stimulator |
|---|---|
| Common/Usual Name: | Electric Muscle Stimulator |
| Classification Name: | Powered Muscle Stimulator, Transcutaneous Electrical |
| Nerve Stimulator (TENS), and Interferential Current | |
| Therapy Stimulator (IFC) |
3. PREDICATE DEVICES
Chattanooga Vectra GENiSYS Stimulator Device K031077
4. DEVICE DESCRIPTION
The Globus Genesy Device is a programmable electro stimulator with multiple uses: Powered Muscle Stimulators, Transcutaneous Electrical Nerve Stimulator. Premodulated Current Therapy Stimulator, and Microcurrent Therapy Stimulator.
Each device in the family comes with a menu to select different stimulation The Stimulation Programs have been subdivided in menus and programs. submenus to facilitate use for various types of uses. The user can create and store protocols in the device for subsequent recall, and can store them and manipulate them in a PC for labeling and stimulation parameter changes.
1
The Globus Genesy electrical impulses trigger excitations that are transmitted to the muscle fibers, where they generate mechanical responses that result in muscle work. This work is used for muscle and range-of-motion rehabilitation therapies.
They also interact with the mechanism of pain generation and transmission in the nerve fibers; other stimulation currents interact directly with the affected body part to obtain the effect desired by the physician or licensed practitioner.
The core of the Globus Genesy 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.
ಸ. INTENDED USE
The Globus Genesy Stimulator is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. It is intended to be used for therapy that adopts NMES, Russian, TENS, Premodulated Currents (IFC), and Microcurrent, waveforms.
The Globus Genesy is not intended to be used as an over-the-counter (OTC) device.
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The Domino S.r.l. Globus Genesy device and the Chattanooga Vectra GENiSYS Stimulator are similar in design and function. Both devices offer:
- · biphasic waveforms, rectangular, symmetrical,
- · asymmetric rectangular waveforms, compensated,
- · monophasic rectangular waveforms.
- · premodulated waveforms,
- · Russian currents,
- · Microcurrents,
Both the Globus and predicate devices are software-driven, electro-stimulator units that provide licensed practitioners with a variety of treatment currents for therapy.
2
The Globus Genesy and the Chattanooga Vectra GENiSYS devices are similar in technical characteristics and performance. The Globus Genesy device maximum current output and its maximum electric charge are very similar to the predicate device.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is simple and recognizable, and it is often used to represent the U.S. Department of Health & Human Services.
Public Health Service
OCT 2 5 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Globus Sport and Health Technologies % Mr. Giovanni Ciriani Managing Partner 18 Eustace Dr. West Hartford, CT 06110
K071431 Re: Trade Name: Globus Genesy 1100 Electro-Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Codes: IPF, GZJ, and LIH Dated: August 31, 2007 Received: September 05, 2007
Dear Mr. Ciriani:
This letter corrects our substantially equivalent letter of September 25, 2007.
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 (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 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
4
Page 2 - Mr. Giovanni Ciriani
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.
This letter will allow you to continue 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) 276-3474. 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/dsma/dsmamain.html
Sincerely yours,
Mark A. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Indications for Use
510(k) Number (if known): K071431
Device Name: Globus Genesy 1100 Stimulator
Indications For 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 for therapies employing NMES, Russian, and Premodulated Currents (IFC) to obtain the following:
- · Relaxation of muscle spasms
- · Prevention or retardation of disuse atrophy
- · Increasing local blood circulation
- · Muscle re-education
- · Maintaining or increasing range of motion
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Additional Indications for Microcurrent, Premodulated Currents (IFC), NMES and TENS waveforms:
- · Management of chronic, intractable pain
- · Post-traumatic acute pain
- · Post-surgical acute pain
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Marls N. Millu
Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number K071431