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FDA Approves Pinook USA’s BH-18 Model Device

24 Sep

Located in Orlando, Florida, Pinook USA distributes a variety of pain relief devices including massagers, heating pads, and assorted accessories. Pinook USA received clearance from the Food and Drug Administration (FDA) for its model BH-18 device, which delivers two types of stimulation to relieve symptoms associated with muscle strain.

The Pinook model BH-18 is a portable, multi-function massage device that delivers both transcutaneous electrical nerve stimulation (TENS) and powered muscle stimulation (PMS). The device applies electrical pulses through adhesive pads placed on various recommended areas of the body. It uses two channels and offers six modes of operation. Manufactured by Johari Digital Healthcare, the device makes use of its TENS channel to temporarily relieve pain, while with its PMS channel it facilitates muscle performance through the stimulation of healthy muscles.

The FDA has labeled it a Class II device and awarded it 510(k) clearance under the product code K132563.