(90 days)
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Not Found
No
The description focuses on standard electrical stimulation technology with adjustable parameters controlled by a microprocessor, without mentioning any AI or ML capabilities for learning, adaptation, or complex pattern recognition.
Yes
The device is described as a "transcutaneous electrical nerve stimulation" (TENS) device used for symptomatic relief of chronic intractable pain and other therapeutic indications such as muscle relaxation, prevention of disuse atrophy, and increasing local blood circulation. These uses are therapeutic in nature.
No
The device's intended use and indications for use describe therapeutic applications (e.g., pain relief, muscle relaxation, muscle re-education, increasing local blood circulation, preventing disuse atrophy, preventing venous thrombosis, increasing range of motion), not the identification or diagnosis of medical conditions.
No
The device description explicitly states that the device consists of a stimulus generator and electrodes, which are hardware components. While software controls the operation modes, the core function relies on physical electrical stimulation delivered through hardware.
Based on the provided information, 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, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that this device is a transcutaneous electrical nerve stimulator (TENS) and powered muscle stimulator. It applies electrical current to electrodes attached to the patient's skin.
- Intended Use: The intended uses listed are for symptomatic relief of pain, muscle relaxation, preventing atrophy, increasing blood circulation, muscle re-education, preventing venous thrombosis, and maintaining range of motion. These are all therapeutic applications, not diagnostic tests performed on specimens.
The device operates externally on the patient's body and does not involve the analysis of biological samples. Therefore, it falls outside the scope of In Vitro Diagnostics.
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
GZJ
Device Description
The Digi-Pro TENS series, including WL-2203, WL-2204, and WL-2205 are transcutaneous electrical nerve stimulators 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: a TENS generator and an electrode. The stimulus generator generates the output current specified by 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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 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
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 r he Dig TTO reason of sed for pain relief and/or powered muscle stimulator by applying an electrical norrent 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: Digit to TENO benerator, electrode. The stimulus generator generates the output current specified 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three abstract human figures, represented by flowing lines, suggesting a sense of movement and connection.
Public Health Service
Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850
Mr. Tony C.S. Chang Well-Life Healthcare Inc. C/o Wincent Consultant No. 5. Alley 5. Lane Cheng Hsing Chung Ching Road, Pei Tun Dist. Taichung, Taiwan, R.O.C.
APR 30 2002
Re: K021359
: Trade/Device Name: Digi-Pro TENS models WL-2203 and WL-2205 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ 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 w o neve roviewed your beeemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass surfed in the energent of the enactment date of the Medical Device Amendments, or to conniner of the 120, 2017, 2017, 11:25 am accordance with the provisions of the Federal Food, Drug, de necs that hat o been require approval of a premarket approval application (PMA). and Cosmetic (110. (110.) that to the general controls provisions of the Act. The r ou may, merelore, mains 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 If your doviet to such additional controls. Existing major regulations affecting your device can may or babyet to back as a saterial 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 compy while and 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 of 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 premailer notification " 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-. Additionally, for questions on the promotion and advertising of your evice, 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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
L. Mark N. Melkerson
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 : 1 of 1
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 Melhumm (Optional Format 3-10-98)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number. K021359