21 CFR 882.5893 — Thermal Vestibular Stimulator For Headache
Neurology (NE) · Part 882 Subpart F—Neurological Therapeutic Devices · § 882.5893
Identification
The thermal vestibular stimulator for headache is a prescription device used to stimulate the vestibular system by applying thermal waveforms through earpieces placed in a patient's ear canal for the treatment of headache.
Classification Rationale
Class II (special controls). The special controls for this device are:
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QAR | Thermal Vestibular Stimulator For Headache | 2 | 1 |
Special Controls
QAR — Thermal Vestibular Stimulator For Headache
In combination with the general controls of the FD&C Act, the thermal vestibular stimulator for headache is subject to the following special controls:
De Novo Order DEN170023
QAR — Thermal Vestibular Stimulator For Headache
*Classification.* Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible. (2) Performance testing must validate electromagnetic compatibility and electrical, mechanical, and thermal safety. (3) The technical parameters of the device, including waveform outputs and temperature limits, must be identified. (4) Cleaning validation of earpieces must be conducted. (5) Software verification, validation, and hazard analysis must be performed. (6) Labeling must include the following: (i) Information on how the device operates and the typical sensations experienced during treatment; (ii) A detailed summary of the device's technical parameters; and (iii) Instructions for maintenance and cleaning of the device.
eCFR
QAR — Thermal Vestibular Stimulator For Headache
(1) The patient-contacting components of the device must be demonstrated to be biocompatible. (2) Performance testing must validate electromagnetic compatibility and electrical, mechanical, and thermal safety. (3) The technical parameters of the device, including waveform outputs and temperature limits, must be identified. (4) Cleaning validation of earpieces must be conducted. (5) Software verification, validation, and hazard analysis must be performed. (6) Labeling must include the following: (i) Information on how the device operates and the typical sensations experienced during treatment; (ii) A detailed summary of the device's technical parameters; and (iii) Instructions for maintenance and cleaning of the device.
Ecfr Llm
