---
kind: "section"
citation: "21 C.F.R. § 882.5894"
title: "21"
number: "882.5894"
heading: "Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites."
url: "https://uscodex.org/cfr/21/882.5894"
---

# §882.5894. Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites.

- (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.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (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) Mechanical bench testing must demonstrate that the device will withstand the labeled number duration of uses.
  - (3) All elements of the device that may contact the patient must be assessed to be biocompatible.
  - (4) Labeling must include:
    - (i) **Validated instructions which addresses the following—**
      - (A) Identification of areas of the body which are appropriate and not appropriate for contact with the device.
      - (B) Whether use of the device in conjunction with flammable materials (e.g., insect repellent) is appropriate.
      - (C) **Use of the device on or near implanted devices.**
      - (D) **How to identify the correct type of skin condition.**
    - (ii) Technical parameters of the device (maximum output voltage (instantaneous), maximum output current (instantaneous), and pulse duration).
    - (iii) Language to direct end users to contact the device manufacturer and MedWatch if they experience any adverse events with this device.
    - (iv) **The anticipated number of device uses prior to failure.**

## Notes

### Amendments

[80 FR 15165, Mar. 23, 2015]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 44 FR 51730, Sept. 4, 1979, unless otherwise noted.

### Amendments

[80 FR 15165, Mar. 23, 2015]