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1. When using Electrical Muscle Stimulation, Transcutaneous Electrical Nerve Stimulator is intended:

• for users with conditions or disease that are associated with impaired (poor) blood flow in the legs/ ankles/ feet, the device through the foot-pads is intended for use as an adjunctive treatment (as an addition to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping
• to temporarily increase local blood circulation in healthy leg muscles
• to stimulate healthy muscles in order to improve and facilitate muscle performance
• to temporarily relieve pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities(legs) due to strain from exercise or normal household duties
• to relax muscle spasm
• to increase blood flow circulation
• for prevention of retardation of disuse atrophy
• for muscle re-education
• for maintaining or increasing range of motion
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Provide quadricep strengthening
• Improve knee stability secondary to quadricep strengthening

2. When using Transcutaneous Electrical Nerve Stimulator to deliver Transcutaneous Electrical Nerve Stimulation (TENS), it is intended to provide:

• symptomatic relief and management of chronic, intractable pain
• relief of pain associated with arthritis
• temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties

Transcutaneous Electrical Nerve Stimulator is a product that adopts modern electronic science and technology to deliver electric pulses generated to the user's skin through the electrodes. The proposed models KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039 provide a combination of transcutaneous electrical nerve stimulation (TENS) and electrical muscle stimulation (EMS). It has the following basic characteristics: 1) 10 modes to satisfy different demands, mode 1-9 is for foot stimulation and mode body is for body stimulation; 2) wonderful electric pulse combination, 0~20 levels can be adjusted and chosen according to personal preference; 3) wireless remote control allows easy control of the device 5) use while seated or reclining; 6) LCD display makes the operation simple and easy. Transcutaneous Electrical Nerve Stimulator is mainly composed of the main unit, remote control and electrode pads.

The provided document is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator, not a study report that includes details about acceptance criteria and device performance based on a test set, expert consensus, or specific clinical outcomes for an AI/ML device. Therefore, I cannot extract the requested information.

The document discusses:

• Device Name and Regulation: Transcutaneous Electrical Nerve Stimulator, Class II medical device.
• Indications for Use: Pain relief and muscle stimulation for various conditions.
• Predicate Device: K220998, also a Transcutaneous Electrical Nerve Stimulator.
• Technical Characteristics Comparison: A detailed table comparing the subject device with the predicate device, highlighting similarities and differences in specifications like power supply, output modes, intensity levels, dimensions, materials, and compliance with voluntary standards.
• Non-Clinical Studies: Lists compliance with various IEC and ISO standards related to electrical safety, EMC, home healthcare environment, nerve and muscle stimulators, and biocompatibility (ISO 10993 series). It also mentions software verification and validation and waveform testing.
• Clinical Information: States "Not applicable."

The absence of "clinical information" indicates that the submission relies on non-clinical testing and substantial equivalence to a predicate device rather than a clinical study demonstrating performance against specific clinical acceptance criteria. There is no mention of an AI/ML component, a test set, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

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