(74 days)
Not Found
No
The summary describes a standard electrical stimulator and explicitly states "Not Found" for mentions of AI, DNN, or ML.
Yes
The device is described as an interferential stimulator with TENS indications for symptomatic relief and management of chronic intractable pain, which directly aligns with the definition of a therapeutic device.
No
The device is described as an interferential stimulator used for symptomatic pain relief and management, which indicates a therapeutic purpose rather than a diagnostic one.
No
The device description explicitly states it is a hardware device ("WL-2206A is the device which generates the small real-sine pulses of electrical current") and includes physical components like cables and electrodes.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is described as an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain. This is a therapeutic use, not a diagnostic one.
- Device Description: The description focuses on generating electrical current to stimulate nerves and relieve pain. This is consistent with a therapeutic device, not a device that analyzes biological samples to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is to directly treat pain through electrical stimulation.
N/A
Intended Use / Indications for Use
The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.
Product codes
IPF
Device Description
The WL-2206A is the device which generates the small real-sine pulses of electrical current. The generated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin. Through the current stimulation the chronic and/or acute pain is to be relieved.
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)
Software verification has been carried out according to the FDA software guidance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
WL-2206 (K024100)
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
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: Ko50847
-
- Submitter's Identifications: Theratech, Inc. 1109 Myatt Blvd, Madison, TN 37115
Contact: Mr. Mike Price
- Submitter's Identifications: Theratech, Inc. 1109 Myatt Blvd, Madison, TN 37115
Date of Summary Preparation: March 2005.
2. Name of the Device:
IF series True sine interferential stimulator / Model: WL-2206A.
3. Information of the 510(k) Cleared Device (Predicate Device):
WL-2206 (K024100) .
4. Device Description:
The WL-2206A is the device which generates the small real-sine pulses of electrical current. The generated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin. Through the current stimulation the chronic and/or acute pain is to be relieved.
5. Intended Use:
The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.
In addition, the standard format for the statement of indications and contraindication for use are provided hereafter.
1
6. Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows:
Compliance to applicable voluntary standards includes ANSI/AAMI, NS4-1985, as well as EN 60601-1, and EN 60601-1-2 requirement.
In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software guidance.
7. Conclusions
The true sine interferential stimulator, model WL-2206A, has the same intended use and technological characteristics as the cleared device of WL-2206 (K024100). Moreover, verification and validation tests contained in this submission Moronstrate that the difference in the submitted demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device.
In the other words, those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a circular seal for the U.S. Department of Health & Human Services. The seal features the department's name around the perimeter in a circular fashion. In the center of the seal is a stylized image of an eagle with its wings spread, which is a common symbol of the United States.
Public Health Service
JUN 1 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael Price Official Correspondent Theratech Incorporated 1109 Myatt Boulevard Madison, Tennessee 37115
Re: K050847
Trade/Device Name: IF series True sine interferential stimulator / Model: WL-2206A Regulatory Class: Unclassified Product Code: IPF Dated: May 6, 2005 Received: May 20, 2005
Dear Mr. Price:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for association 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 I ou may, merclere, mains of the Act include requirements for annual registration, listing of general controls profitions 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.
3
Page 2 - Mr. Mike Price
This letter will allow you to begin marketing your device as described in your Section 510(k)
The success of any of a lot a first and starticle spiralence of your device to a This letter will allow you to begin marketing your active of your device of your device to a legally
premarket notification. The FDA finding of substantial equipe of the pe premarket notification. The FDA Inding of backansa organity of the 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
rst lead If you desire specific advice for your de necessor of views note the regulation entitled, the regulation entitled, the contact the Office of Compulance at (210) 278 ation" (21CFR Part 807.97). You may obtain "Misbranding by relerence to peniance notification (the Act from the Division of Small)
other general information on your responsibilities under the Act from the 6800 638.00 other general information on your responsion installed on the enumber (800) 638-2041 or 1980) of the Manufacturers, International and Consulter 11bostoner of carb/industry/support/index.html.
Sincerely yours,
Sincercly yours,
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
1050844 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: JF series True sine interferential stimulator / Model: WL-2206A.
Indications For Use:
The device is an interferential stimulator with TENS indications used for The device is an interferential stimatic intractable pain.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✓ OR
Over-The-Counter Use __
Division of General, Restorative
and Neurological Devices (Optional Format 1-2-96)