(25 days)
Not Found
No
The summary describes a standard electrical stimulator and makes no mention of AI, ML, or related concepts.
Yes
The device is described as an "interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain," which clearly indicates a therapeutic purpose.
No
Explanation: The device is described as an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain, which is therapeutic, not diagnostic.
No
The device description explicitly states that the device "generates the small true-sine pulses of electrical current" and delivers it through a "cable and electrode," indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "symptomatic relief and management of chronic intractable pain" by delivering electrical current to the patient's skin and nerves. This is a therapeutic application, not a diagnostic one.
- Device Description: The device generates electrical pulses and delivers them to the patient's body. This is consistent with a physical therapy or pain management device, not a device that analyzes samples from the body (which is the core of IVD).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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 (comma separated list FDA assigned to the subject device)
LIH
Device Description
The WL-2206B and WL-2106E are the device which generates the small true-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.
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
§ 882.5890 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
This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K090023
JAN 3 0 2009
1. Submitter's Identifications:
| Company Name: | Well Life Healthcare Limited |
|---|---|
| Contact person: | Jenny Hsieh |
| Address: | 1FL., No.16, Lane 454, Jungjeng Rd., Yunghe City, Taipei County, |
| Taiwan, R.O.C. | |
| TEL No.: | 886-2-2928-2112 |
| Fax No.: | 886-2-2928-1880 |
| E-mail address: | jenny@welllifehealthcare.com.tw |
2. Name of the Device:
IF series True sine interferential stimulator / Model: WL-2206B & WL-2106E.
3. Information of the 510(k) Cleared Device (Predicate Device):
WL-2206A2 (K060975).
4. Device Description:
The WL-2206B and WL-2106E are the device which generates the small true-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.
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.
6. Substantial Equivalence Comparison
The WL-2206B and WL-2106E have output characteristics and controls that are identical to those of the predicate device. The new devices are different in that WL-2106E is controlled using knobs and multi-position switches versus input buttons in conjunction with an LCD display. WL-2206B is functionally identical to WL-2206A2.
1
7 . 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.
8. Conclusions
The true sine interferential stimulator, model WL-2206B & WL-2106E, has the same intended use and technological characteristics as the cleared device of WL-2206A2 (K060975). 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is depicted in a simple, abstract style, with bold lines forming its shape. The text is in uppercase letters and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3.0 2009
Well Life Healthcare Limited % Ms. Jenny Hsieh 1Fl., No. 16, Lane 454 Jungjeng Road Yunghe City, Taipei County Taiwan, R.O.C.
Re: K090023
Trade/Device Name: IF series True sine interferential stimulator/Model: WL-2206B & WL-2106E
Regulatory Class: Unclassified Product Code: LIH Dated: January 5, 2009 Received: January 5, 2009
Dear Ms. Hsieh:
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 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.
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Page 2 - Ms. Jenny Hsieh
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Milkersan
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: IF series True sine interferential stimulator / Model: WL-2206B & WL-2106E.
Indications For Use:
The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.
(Division Sigi Division of Ge
1946 11 34
Division of General, Restorative, and Neurological and Neurological Devices
510(k) Number
51%(%) Numbe
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V OR
Over-The-Counter Use
(Optional Format 1-2-96)