21 CFR §882.5894

1. (a)Identification. A limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites is a device intended to alleviate skin reactions associated with insect bites via cutaneous, piezoelectric stimulation at the local site of the bite.
2. (b)Classification. Class II (special controls). The special controls for this device are:
   1. (1)Appropriate testing to characterize the electrical output specifications of the device (i.e., total charge delivered, maximum instantaneous output current, maximum instantaneous output voltage, pulse duration, charge density) must be conducted.
   2. (2)Mechanical bench testing must demonstrate that the device will withstand the labeled number duration of uses.
   3. (3)All elements of the device that may contact the patient must be assessed to be biocompatible.
   4. (4)Labeling must include:
      1. (i)Validated instructions which addresses the following:
         1. (A)Identification of areas of the body which are appropriate and not appropriate for contact with the device.
         2. (B)Whether use of the device in conjunction with flammable materials (e.g., insect repellent) is appropriate.
         3. (C)Use of the device on or near implanted devices.
         4. (D)How to identify the correct type of skin condition.
      2. (ii)Technical parameters of the device (maximum output voltage (instantaneous), maximum output current (instantaneous), and pulse duration).
      3. (iii)Language to direct end users to contact the device manufacturer and MedWatch if they experience any adverse events with this device.
      4. (iv)The anticipated number of device uses prior to failure.