(33 days)
Not Found
No
The description focuses on the material and construction of conductive garment electrodes, with no mention of AI or ML capabilities.
Yes
The intended use states that the electrodes are to be used with TENS and NMES stimulating devices, which are therapeutic devices. Although the garments themselves are not delivering the therapy, they are an essential component of a therapeutic system.
No
The document describes garment electrodes used with TENS and NMES devices for delivering stimulation signals, not for identifying or characterizing a disease or condition.
No
The device description clearly states it is a physical garment made of conductive yarn, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the TheraKnit Garment Electrodes are "cutaneous electrodes to be used with legally marketed TENS and NMES stimulating devices." These devices are used for delivering electrical stimulation to the body for therapeutic purposes (pain relief, muscle stimulation).
- Device Description: The description details the physical characteristics of the garments and how they conduct electrical signals to the skin.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples outside of the body. The TheraKnit Garment Electrodes are external electrodes used for delivering electrical stimulation directly to the body.
N/A
Intended Use / Indications for Use
TheraKnit garment cutaneous electrodes as glove, socks, sleeves and pads are intended for use with legally marketed electrostimulation devices such as TENS and NMES to deliver stimulation current for pain relief. They can be used on body parts such as hands, feet, arms, legs, low back and shoulder for pain relief using electrostimulation.
The TheraKnit Garment Electrodes are cutaneous electrodes to be used with legally marketed TENS/NMES stimulator device. The knitted garments conduct the stimulation signals generated by the stimulator to the body parts with which they are in contact. These body parts include: hands, feet, arms, legs, shoulder, back (pads).
Product codes
GXY
Device Description
The TheraKnit Garment Electrodes are conductive garments knitted from a continuous silver coated Nylon yarn into the form of gloves, socks, sleeves and flat fabric used for pads. The conductivity is derived from the silver content of the Nylon yarn. The garment electrodes are available in a variety of sizes ranging from small to extra large for gloves and small to large for socks and sleeves. The elongation property of the nylon yarn provides some elasticity which ensures firm skin contact. The devices can be used dry or wet when in contact with the skin. The entire surface of each garment electrode is very conductive having a resistance of less than 7 ohms per inch. This low resistance provides low current density with uniform current distribution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands, feet, arms, legs, low back and shoulder
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
Comparative testing was done between the TheraKnit garments and the predicate devices for resistance measurement and comparison.
Summary of Performance Studies
Bench testing has been done with this device demonstrating that it meets design controls.
Comparative testing was done between the TheraKnit garments and the predicate devices for resistance measurement and comparison. Design specifications, comparison to predicate device specifications and testing has demonstrated that this TheraKnit device meets design requirements and is equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).
0
K0532/4
OEC 2 0 2005
510(k) Summary
Trade Name: TheraKnit
Common/Classification Name: Electrode, Cutaneous (84GXY) 21 CFR 882.1320
Neurotron Medical, Inc. 800 Silvia Street West Trenton, NJ 08628 800-367-1238
Contact: Jack Guldalian, President
Prepared: August 24, 2005
LEGALLY MARKETED PREDICATE DEVICES A.
K932299 Electro-Mesh Glove Electrode Prizm Medical, Inc.
K944487 Electro-Mesh Sock, Wrap and Sleeve Electrodes Prizm Medical, Inc.
K943009 SMD Glove, Sock and Sleeve Electrodes Scientific Medical Devices, Inc.
DEVICE DESCRIPTION B.
The TheraKnit Garment Electrodes are conductive garments knitted from a continuous silver coated Nylon yarn into the form of gloves, socks, sleeves and flat fabric used for pads. The conductivity is derived from the silver content of the Nylon yarn. The garment electrodes are available in a variety of sizes ranging from small to extra large for gloves and small to large for socks and sleeves. The elongation property of the nylon yarn provides some elasticity which ensures firm skin contact. The devices can be used dry or wet when in contact with the skin. The entire surface of each garment electrode is very conductive having a resistance of less than 7 ohms per inch. This low resistance provides low current density with uniform current distribution.
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INTENDED USE C.
TheraKnit garment cutaneous electrodes as glove, socks, sleeves and pads are intended for use with legally marketed electrostimulation devices such as TENS and NMES to deliver stimulation current for pain relief. They can be used on body parts such as hands, feet, arms, legs, low back and shoulder for pain relief using electrostimulation.
SUBSTANTIAL EQUIVALENCE SUMMARY D.
The TheraKnit Garment Electrode is a medical device that has the same indication, intended use and target population as the legally marketed predicate devices.
TheraKnit has the same technological characteristics as the predicate rneraKhit hab the stheraKnit and the predicate devices are made with a silver plated nylon yarn. The resistance of the knitted garment for both TheraKnit and the predicate devices are less than 7 ohms/inch which is very low relative to the delivery of the stimulation current.
Both TheraKnit and the predicate devices receive the electrostimulation signal from a legally marketed TENS or NEMS device through a lead wire signal from a logally markets connected to a snap connector on the knitted garment device.
Both TheraKnit and the predicate devices are washable and intended for single patient use.
TECHNOLOGICAL CHARACTERISTICS E.
The TheraKnit garment electrodes are made from a silver plated nylon rne Therakhit gurment elections process. The fabric is highly conductive yarri asing a comments ohms resistance per inch. The device can be and provides less and interestive polarity, a second electrode is used with element the stimulator current to the target tissue and necessary to direct the samalator of e device is washable using conventional complete the clecencal circuit.
detergents without adverse effect on the conductivity of the device.
The garment electrodes provide a snug elastic fit based upon the 37% The garment characteristic of the yarn used in the construction.
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F. TESTING
ﻪ
Bench testing has been done with this device demonstrating that it meets design controls.
Comparative testing was done between the TheraKnit garments and the predicate devices for resistance measurement and comparison.
CONCLUSIONS G.
Design specifications, comparison to predicate device specifications and testing has demonstrated that this TheraKnit device meets design requirements and is equivalent to the predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 0 2005
Neurotron Medical, Inc. c/o Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW Buffalo Minnesota 55313
Re: K053214/S1
Trade/Device Name: Theraknit Garments Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: II Product Code: GXY Dated: December 2, 2005 Received: December 5, 2005
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device indication we nave reviewed your Section 910(t) premance is substantially equivalent (for the ndications for referenced above and have decemined the ac-10 in the east and the starter and courses that use stated in the enclosure) to tegally management date of the Amendments, or to devices that prob to May 26, 1976, the chacinent auto of the Federal Food, Drug, and Cosmetic have been reclassified in accordance will atte por head. In and possible at on the Act . The consember Act (Act) that do not require apple for the general controls provisions of the Act. The general therefore, market the device, subject to the expirements for annual registration, listing of devices, good controls provisions of the nechade requibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classined (see ao roy mite existing major regulations affecting your device can be may be subject to such additional controls. Exhould may - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 1 found in the Oods of concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that Please be advised mat 1 DX 3 losained of aevice complies with other requirements of the Act or any FDA has made a decemination that your development. You must comply with all rederal statutes and regulations as annuws t limited to: registration and listing (21 CFR Part 807): the ree s requirements, and manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and 1f applicable, the electronic form in the quality bytellio (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin maneting of substantial equivalence of your deversite vaux develop premarket nothleation. The IDA midnig of sactantial vice and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Patt 801), please If you desire specific advice for your do riou on our can and one mote the regulation entitled, and Comact the Office of Compliance at (210) 21 0 0 0 0 0 7.97). You may obtain other "Misbranding by telefence to premation (2) & From the Division of Small Manufacturers, general miormation on your responsionales and its tool-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
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Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): KOS3214
Device Name: TheraKnit
Indications For Use:
The TheraKnit Garment Electrodes are cutaneous electrodes to be used with legally marketed The The Therant Garment Electrodes are each over the stimulation signals TENS Sumblating device. The knitted garniers with which they are in contact. These body parts generated by the stimulator to the body behace man har har heg, shoulder, back (pads).
Prescription Use _ × (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
2
(Division St. Oor
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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