(75 days)
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 relates to therapeutic purposes.
No
The device is described as an "interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain," indicating a therapeutic rather than diagnostic function. It generates electrical current to relieve pain, not to identify or characterize medical conditions.
No
The device description explicitly states it is a device that "generates the small real-sine pulses of electrical current" and delivers it through a "cable and electrode," indicating it includes hardware components for electrical stimulation.
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 about a person's health. This testing is done outside the body (in vitro).
- Device Function: The description clearly states the device is an "interferential stimulator with TENS indications" that generates electrical current delivered to the patient's skin and nerves. This is a form of physical therapy/pain management that acts on the body (in vivo).
- Lack of Specimen Analysis: There is no mention of collecting or analyzing any biological specimens from the patient.
The device described is a therapeutic device used for pain relief through electrical stimulation, not a diagnostic device that analyzes samples.
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
LIH
Device Description
The WL-2206 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
IF-400 (K930535), IF-4000 (K952683)
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
Theratech, Inc.
510(K) SUMMARY
Ko24100
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: _______________________________________________________________________________________________________________________________________________
FEB 2 5 2003
-
- 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: September, 2002.
-
- Name of the Device:
IF series True sine interferential stimulator / Model: WL-2206, Well IF, Life IF and the customer private brand.
- Name of the Device:
-
- Device Description:
The WL-2206 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.
- Device Description:
-
- Intended Use:
The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.
- Intended Use:
In addition, the standard format for the statement of indications and contraindication for use are provided hereafter.
1
510(K) SUMMARY
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, EN 60601-1-1, 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-2206, has the same intended use and technological characteristics as the cleared device of IF-400 (K930536), and IF-4000 (K952683). Moreover, verification and validation tests contained in this submission demonstrate 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
Image /page/2/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The caduceus is depicted with three intertwined snakes and a staff, representing healing and medicine. The seal is simple and professional, reflecting the department's role in public health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 5 2003
Tony C.S. Chang Wincet Consultant Co., Ltd. No. 5. Alley 5. Lane Cheng Hsing Chung Ching Rd., Pei Tun District Taichung, Taiwan, R.O.C.
Re: K024100
Trade/Device Name: IF series True sine interferential stimulator models: WL-2206, Well IF, and Life IF Regulation Number: Unclassified Regulation Name: Interferential Stimulator Regulatory Class: Unclassified Product Code: LIH Dated: December 6, 2002 Received: December 12, 2002
Dear Mr. Chang:
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
3
Page 2 – Mr. Tony C.S. Chang
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 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, 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). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N Milliman
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
4
Theratech, Inc.
510(K) SUMMARY
Page 1 of 1
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: JF series True sine interferential stimulator / Model: WL-2206, Well IF, Life IE and the customer private brand.
Indications For Use:
The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.
Mila N. Millikan
- Restmative Ugar at the lees
(k) Number .
(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 |
(Optional Format 1-2-96)