(121 days)
Not Found
No
The summary describes a passive electrode device and does not mention any computational or algorithmic components, let alone AI/ML.
Yes.
The device, GMDASZ TENS Electrodes, is intended for use with electrical stimulators (TENS, EMS, IF, PGF) to apply electrical stimulation current to the patient's skin, which is a therapeutic function.
No
Explanation: The device is described as an electrode for applying electrical stimulation current for therapeutic purposes (TENS, EMS, etc.), not for diagnosing conditions or diseases.
No
The device description clearly outlines physical components like fabric, foam, conductive plastic film, hydro gel, and lead wires, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the electrodes are for applying electrical stimulation current to the patient's skin for therapeutic purposes (TENS, EMS, IF, PGF). This is a direct interaction with the patient's body for treatment, not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details the physical components and how the electrodes function as an interface for electrical stimulation. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring biomarkers or analytes
The device is a component used in electrotherapy, which is a physical therapy modality.
N/A
Intended Use / Indications for Use
The GMDASZ TENS Electrodes are intended for use as a reusable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. GMDASZ's reusable electrodes are designed and intended to be used with marketed, Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation).
The electrotherapy electrodes are intended to be used to apply electrical stimulation current to the patient's skin.
Product codes (comma separated list FDA assigned to the subject device)
GXY
Device Description
GMDASZ TENS electrodes are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application (Refer to attached BOM):
First layer—insulating backing material: Fabric, foam or tan fabric Second layer—Conductive plastic film Third Layer – Biocompatible self-adhesive conductive hydro gel Protective liner-PET
The electrodes are designed for single-patient/ multiple application use. Because of the adhesive nature of the biocompatible conductive hydro gel, no securing materials are required to secure the device to the patient's skin. The electrode is connected to the stimulating device by lead wire, with a standard .080" recessed female terminal with insulating outer jacket. By design, the insulated outer jacket prevents the conductive connection to earth or hazardous voltages as required in IEC60601-1 Subclause 56 3(c). Wire assembly is incompliance with FDA performance standard 21 CFR Part 898.
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): 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.
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
§ 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).
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510(k) Summary
DEC 1 8 2009
510(k): K092546
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: July 18, 2009
- Company and Correspondent making the submission:
Name - GMDASZ Manufacturing Co., Ltd.
Address – E-1308, Xihaimingzhu Building,
Nanshan District, Shenzhen City
Guangdong Province, China
Telephone - +86 755 86250965
Fax – +86 755 26669658
Contact - Xiangjie Zhang
Email – gmdasz@188.com
- Device :
Trade/proprietary name: GMDASZ TENS Electrodes
Common Name : Cutaneous electrode
Classification Name : electrode, cutaneous
Predicate Devices:
| Predicate
| Model | Manufacturer | K Number | Submitted Device |
|---|---|---|---|
| ValuTrode | Axelgaad | ||
| Manufacturing Co., | |||
| Ltd | K970426 | GMDASZ TENS Electrodes | |
| EZ-Stik | NAlmco, Inc. | K050469 | GMDASZ TENS Electrodes |
1
-
- Classifications Names & Citations : 21CFR 882.1320, GXY, Cutaneous Electrode
4. Description :
4.1 General
GMDASZ TENS electrodes are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application (Refer to attached BOM):
First layer—insulating backing material: Fabric, foam or tan fabric Second layer—Conductive plastic film Third Layer – Biocompatible self-adhesive conductive hydro gel Protective liner-PET
The electrodes are designed for single-patient/ multiple application use. Because of the adhesive nature of the biocompatible conductive hydro gel, no securing materials are required to secure the device to the patient's skin. The electrode is connected to the stimulating device by lead wire, with a standard .080" recessed female terminal with insulating outer jacket. By design, the insulated outer jacket prevents the conductive connection to earth or hazardous voltages as required in IEC60601-1 Subclause 56 3(c). Wire assembly is incompliance with FDA performance standard 21 CFR Part 898.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the eagle. The eagle is depicted in a simple, abstract style, with thick, curved lines forming its body and wings. The text is in all caps and is arranged to follow the curve of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring. MD 20993-0002
GMDASZ Manufacturing Co., LTD c/o Mr. Charlie Mack Principal Engineer International Regulatory Consultants, LLC 77325 Joyce Way Echo, Oregon 97826
Re: K092546
Trade/Device Name: GMDASZ TENS ELECTRODES, Models CWN1005, CWN1007, CWN2505, CWN2509, ACWN1005, ACWN1007, ACWN2505, ACWN2509
DEC 1 8 2009
Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: II Product Code: GXY Dated: November 28, 2009 Received: December 7, 2009
Dear Mr. Mack:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to http://www.fda.gov/cdrl/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Kesia Alexander for
Malvina B. Eydelman, M.D. Director Division of Ophthalmic. Neurological. and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
1092546 510(k) Number (if known):
Device Name: GMDASZ TENS Electrodes
Indications for Use:
The GMDASZ TENS Electrodes are intended for use as a reusable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. GMDASZ's reusable electrodes are designed and intended to be used with marketed, Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation).
The electrotherapy electrodes are intended to be used to apply electrical stimulation current to the patient's skin.
イ 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K092546