(183 days)
Not Found
No
The device description and other sections do not mention AI, ML, or any related concepts. The device is described as a simple electrical signal generator.
Yes
The device is described as an electrical signal generator that stimulates peripheral nerves for pain relief and is indicated for various pain management and muscle stimulation purposes, which are therapeutic applications.
No
The device description and intended use outline therapeutic applications (pain management, muscle stimulation) rather than diagnostic functions. It generates electrical signals to stimulate nerves and muscles, not to detect or analyze medical conditions.
No
The device description explicitly states it is an "electrical signal generator" that applies "sinusoidal current through two pairs of contact electrodes." This indicates the presence of hardware components (the generator and electrodes) that are integral to the device's function, not just software controlling external hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The provided description clearly states that this device is an "electrical signal generator" that applies current through electrodes to stimulate peripheral nerves and muscles. It works on the body, not with specimens taken from the body.
- Intended Use: The intended uses listed are for pain management and muscle stimulation, which are therapeutic applications, not diagnostic ones based on analyzing biological samples.
Therefore, based on the provided information, this device falls under the category of an electromedical device used for therapeutic purposes, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
This device is an electrical signal generator which applies sinusoidal current through two pairs of contact electrodes using temporal interference patterns to stimulate peripheral nerves for the purpose of providing pain relief or as an adjunctive treatment in physical therapy per guidelines in the indications for use. As an alternative, this device can perform the forementioned functions by applying sinusoidal current through only one pair of electrodes.
PAIN MANAGEMENT
Indications for Electromedical Treatment
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- For adjunctive treatment of post-traumatic pain syndromes.
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- For management and symptomatic relief of chronic (long-term) intractable pain.
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- As an adjunctive treatment in the management of post-surgical pain problems.
MUSCLE STIMULATION
Indications for Electromedical Treatment
- As an adjunctive treatment in the management of post-surgical pain problems.
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- Relaxation of muscle spasms.
-
- Prevention or retardation of disuse atrophy
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- Increasing local blood circulation
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- Muscle reeducation
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- Immediate post-surgical stimulation of calf muscle to prevent phlebothrombosis.
-
- 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.
- Maintaining or increasing range of motion
Product codes
LIH, IPF, GZJ
Device Description
This device is an electrical signal generator which applies sinusoidal current through two pairs of contact electrodes using temporal interference patterns to stimulate peripheral nerves for the purpose of providing pain relief or as an adjunctive treatment in physical therapy per guidelines in the indications for use. As an alternative, this device can perform the forementioned functions by applying sinusoidal current through only one pair of electrodes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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
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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
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).
0
510 (k) Summary
- Trade name NEO GeneSys 2k .
- . Classification name - Interferential Current Therapy device, Product Code LIH (Unclassified), IPF, GZJ
The legally marketed device to which our firm is claiming equivalence is the ProElecDT, K930263. [807.92(a)(3)].
Description and Intended Use [807.92(a)(4)] and {807.92(a)(5)]
This device is an electrical signal generator which applies sinusoidal current through two pairs of contact electrodes using temporal interference patterns to stimulate peripheral nerves for the purpose of providing pain relief or as an adjunctive treatment in physical therapy per guidelines in the indications for use. As an alternative, this device can perform the forementioned functions by applying sinusoidal current through only one pair of electrodes.
Summary of the technological characteristics [807.92(a) (6)]
There is no difference in technological characteristics between this device and the predicate device.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 4 2003
Sanexas International GmbH C/o Mr. Gene Kelly Regulatory/Clinical Consultants, Inc. 200 NE Mulberry, Suite 200 Lee's Summit, MO 64086
Re: K022433
Trade/Device Name: NEO GeneSys 2k Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF, LIH, GZJ Dated: October 31, 2002 Received: November 1, 2002
Dear Mr. Kelly:
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
2
Page 2 - Mr. Kelly
forth in the quality systems (OS) 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 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 (301) 594-4639. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
L. Mark N. Millers
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
NEO GeneSys 2k
PAIN MANAGEMENT
Indications for Electromedical Treatment
-
- For adjunctive treatment of post-traumatic pain syndromes.
-
- For management and symptomatic relief of chronic (long-term) intractable pain.
-
- As an adjunctive treatment in the management of post-surgical pain problems.
MUSCLE STIMULATION
Indications for Electromedical Treatment
-
- Relaxation of muscle spasms.
-
- Prevention or retardation of disuse atrophy
-
- Increasing local blood circulation
-
- Muscle reeducation
-
- Immediate post-surgical stimulation of calf muscle to prevent phlebothrombosis.
-
- 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.
Mark N. Milkerson
:10(k) Number