Search Results

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.

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.

The provided text describes a 510(k) summary for a Transcutaneous Electrical Nerve Stimulation Device (TENS) called Digi-Pro TENS, but does not contain any information about acceptance criteria or a study proving its performance against acceptance criteria.

The document primarily focuses on:

• Submitter's Identification: Well-Life Healthcare Inc.
• Device Name: Well-Life TENS (Digi-Pro TENS series, including WL-2203, WL-2204, WL-2205).
• Information of the 510(k) Cleared Device (Predicate Device): Refers to Part 6, which is not provided.
• Device Description: Explains the basic function of the TENS device (stimulus generator, electrode, adjustable output/waveform, different operation modes via microprocessor control).
• Intended Use: Mentions that intended uses and contraindications are defined in the instruction manual and also provides a standard format for indications for use for different models (WL-2203 and the "TENS function" of WL-2205 for chronic intractable pain relief; WL-2204 and the "EMS function" of WL-2205 for muscle spasms, disuse atrophy, blood circulation, muscle re-education, post-surgical calf stimulation, and range of motion).
• FDA Communication (K020314): A letter from the FDA confirming substantial equivalence to legally marketed predicate devices, classifying the device as Class II (Powered muscle simulator), and outlining general controls and regulatory requirements.

Therefore, I cannot provide the requested information about acceptance criteria or a study proving the device meets them based on the text provided. The document is a 510(k) summary for regulatory clearance, not a clinical or performance study report.

Ask a specific question about this device