(90 days)
WL-2203,WL-2204,WL-2205
Not Found
No
The description details a standard electrical stimulator with adjustable output controlled by a microprocessor and software, with no mention of AI or ML capabilities.
Yes
The device is a transcutaneous electrical nerve stimulator used for pain relief and/or powered muscle stimulation, with explicit indications for therapeutic purposes such as symptomatic relief of chronic intractable pain, relaxation of muscle spasms, and increasing local blood circulation.
No
The device is described as a "transcutaneous electrical nerve stimulator" for "pain relief and/or powered muscle stimulator." Its indicated uses are for symptomatic relief of pain, muscle relaxation, prevention of disuse atrophy, increasing blood circulation, muscle re-education, post-surgical stimulation, and maintaining or increasing range of motion. None of these functions involve identifying, diagnosing, or characterizing a disease or condition; instead, they are therapeutic interventions.
No
The device description explicitly states that the device consists of a stimulus generator and electrodes, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the device is a "transcutaneous electrical nerve stimulator" and/or "powered muscle stimulator" that applies an electrical current to electrodes attached to the patient's skin. This is an external application of energy to the body, not a test performed on a sample taken from the body.
- Intended Use: The intended uses listed (pain relief, muscle stimulation, etc.) are all related to applying electrical stimulation to the body for therapeutic purposes, not for diagnosing conditions based on in vitro analysis.
Therefore, the Digi-Pro TENS series is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Indications For Use (Available for WL-2203 & 'TENS function' of WL-2205):
This device is a prescription device and only for symptomatic relief of chronic intractable pain.
Indications For Use (Available for WL-2204 & 'EMS function' of WL-2205):
- Relaxation of muscle spasms.
- Prevention or retardation of disuse atrophy.
- Increasing local blood circulation.
- Muscle re-education.
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
- Maintaining or increasing range of motion.
Product codes
IPF
Device Description
The Digi-Pro TENS series, including WL-2203, WL-2204, and WL-2205 are transcutaneous electrical nerve stimulator used for pain relief and/or powered muscle stimulator by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the situation of patient.
Digi-Pro TENS series, models WL-2203, WL-2204, and WL-2205, consist mainly of two parts: the stimulus generator, electrode. The stimulus generator generates the output current specified as the input of controller. The output port transmits the output current to the electrode, which is attached to the patient's skin so as to transmit this stimulus current to the patient for pain relief.
The stimulation mode for Digi-Pro TENS includes several different operation modes as mentioned on the comparison table. These operation modes are generated from the software control by using the microprocessor as its main control unit.
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)
Not Found
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: _______________________________________________________________________________________________________________________________________________
-
- Submitter's Identifications: Well-Life Healthcare Inc. Room 6C01, No. 5, Sec. 5, Hsin Yi Rd., Taipei. Taiwan, R.O.C.
Contact: Ms. Grace Chang Sales Manager
- Submitter's Identifications: Well-Life Healthcare Inc. Room 6C01, No. 5, Sec. 5, Hsin Yi Rd., Taipei. Taiwan, R.O.C.
Date of Summary Preparation: December, 2001.
-
- Name of the Device:
Well-Life TENS (Transcutaneous Electrical Nerve Stimulation Device), Model Digi-Pro TENS series, including WL-2203, WL-2204, and WL-2205.
- Name of the Device:
-
- Information of the 510(k) Cleared Device (Predicate Device): Please see the information provided in part 6 of this summary.
4. Device Description:
The Digi-Pro TENS series, including WL-2203, WL-2204, and WL-2205 are transcutaneous electrical nerve stimulator used for pain relief and/or powered muscle stimulator by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the situation of patient.
Digi-Pro TENS series, models WL-2203, WL-2204, and WL-2205, consist mainly of two parts: the stimulus generator, electrode. The stimulus generator generates the output current specified as the input of controller. The output port transmits the output current to the electrode, which is attached to the patient's skin so as to transmit this stimulus current to the patient for pain relief.
The stimulation mode for Digi-Pro TENS includes several different operation modes as mentioned on the comparison table. These operation modes are generated from the software control by using the microprocessor as its main control unit.
5. Intended Use:
On the instruction manual of each model, the intended uses and contraindication are defined very clearly. Please see the information of instruction manuals in clause 7.6 of this submission document.
In addition, the standard format for the statement of indications and contraindication for use are provided hereafter.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Tony C.S. Chang Well-Life Healthcare Inc. C/o Wincent Consultant No. 5. Allev 5. Lane Cheng Hsing Chung Ching Road, Pei Tun Dist. Taichung, Taiwan, R.O.C.
APR 30 2007
Re: K020314
Device Name: Digi-Pro TENS models WL-2204 and WL-2205 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle simulator Regulatory Class: Class II Product Code: IPF Dated: January 18, 2002 Received: January 30, 2002
Dear Mr. Tony 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
2
Page 2 - Mr. Tony Chang
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This production volta on verin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally prematication. The 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 additionally 21 Of Crair on Additionally, for questions on the promotion and advertising of your Occipitalies at (over of Compliance at (301) 594-4639. Also, please note the do nov, proase tool "Misbranding by reference to premarket notification" (21CFR Part 807.97). regaration on the formation on your responsibilities under the Act may be obtained from the Ouvision 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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark M Melleusen
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
3
Page
510(k) Number (if known):
Device Name:__Digi-Pro TENS / Model: WL-2203, WL-2204, WL-2205
Indications For Use (Available for WL-2203 & 'TENS function' of WL-2205):
This device is a prescription device and only for symptomatic relief of chronic intractable pain.
Indications For Use (Available for WL-2204 & 'EMS function' of WL-2205):
- Relaxation of muscle spasms.
- Prevention or retardation of disuse atrophy.
- Increasing local blood circulation.
- Muscle re-education.
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
- Maintaining or increasing range of motion.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Mark n Millenn
(Division Sign-Off)
(Optional Format 3-10-98)
Division of General, Restorative
and Neurological Devices
510(k) Number. K020314