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This TENS device is to be used for temporary relief of pain associated with sore or aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

The Counter Pain Therapy Device, Model P.T.S.-IV (K161537) is identical to the previous cleared version of the device with the same name (K132993). The purpose of this 510(k) submission is to seek different (expanded) Indications for Use. The only changes are in the 'Indication for Use Statement'. The Counter Pain Therapy Device, Model P.T.S.-IV features two channels and seven (7) preset programs. The output of both channels can be adjusted individually for intensity in sixteen (16) steps and the treatment time is selectable from 20, 30 or 40 minutes. All features are well indicated by large icons on a backlit LCD screen for easy reading. The device is powered by three (3) rechargeable Lithium Batteries which are permanently built into the main unit and can be recharged with the charging unit supplied for the device. The Pain Therapy Device consists of the handheld main unit (controller), two pairs of self-adhesive electrodes, a plug-in charging unit (adaptor 120VAC to 5VDC) and two pairs of electrode cables.

To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back due to strain from exercise or normal household work activities (Choose Mode A, B, or C) To be used for temporary relief of pain associated with sore and aching muscles in the upper extremities (Arms) due to strain from exercise or normal household work activities (Choose Mode A, B or C) To be used for temporary relief of pain associated with sore and aching muscles in the lower extremities (Legs) due to strain from exercise or normal household work activities (Choose Mode A, B or C) To be used for symptomatic relief and management of chronic, intractable pain associated with Arthritis (Choose Mode A) To stimulate healthy muscles in order to improve and facilitate muscle performance (Choose Mode B)

The Pain Therapy System, Model PTS-II is a selectable dual channel TENS and EMS device operated by DC 3.0V (AAA*2 batteries). It is made up of one main unit, two electrode cables, and two pairs of electrode pads. There are 3 selectable, pre-programmed output waveforms (modes) to choose from. The two channels share one knob to adjust, the intensity are adjustable from 0 to 5. Running time can be selected among 10, 20 or 40min and recycled. There is a dial with on/off on the side that enables the device to be turned on or off, and it can be used to adjust the output intensity level, turn clockwise to increase intensity and turn anticlockwise to decrease the intensity. In the front of the device, there are 2 buttons and 6 indicator lights, in which one button is the mode selection button, and the other is for time selection. There are three modes A. B. C. respectively indicated by three indicator lights, which are on the right of the mode selection button. The device has 3 timing levels, namely 10, 20, 40 min, and indicated by three indicator lights, which are on the right of the timing selection button.

To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back due to strain from exercise or normal household work activities choose Manual modes A, B, C, D, F, E or Auto 4. To be used for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) due to strain from exercise or normal household work activities choose Manual modes A, B, C, D, F, E or Auto 1 or Auto 3.. To be used for temporary relief of pain associated with sore and aching muscles in the lower extremities (leg) due to strain from exercise or normal household work activities choose Manual modes A, B, E or Auto 1 or Auto 4. To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, choose Manual modes A and C or Auto 1, Auto 2, Auto 3, or Auto 4. To be used to stimulate healthy muscles in order to improve and facilitate muscle performance choose Manual Mode A or Mode B.

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This TENS Device is to be used for temporary relief of pain associated with sore or aching muscles of lower back, arms, or legs due to strain from exercise or normal household and work activities.

The Counter Pain Therapy Device, Model P.T.S.-IV features two channels and seven (7) preset programs. The output of both channels can be adjusted individually for intensity in sixteen (16) steps and the treatment time is selectable from 20, 30 or 40 minutes. All features are well indicated by large icons on a backlit LCD screen for easy reading. The device is powered by three (3) rechargeable Lithium Batteries which are permanently built into the main unit and can be recharged with the charging unit supplied for the device. The Pain Therapy Device consists of the handheld main unit (controller), two pairs of self-adhesive electrodes, a plug-in charging unit (adaptor 120VAC to 5VDC) and two pairs of electrode cables.