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Thermal Vestibular Stimulator For Headache

Page Type
Product Code
Definition
The device is intended to stimulate the vestibular system using thermal waveforms in the ear canals for treatment of migraine headache.
Physical State
The device resembles a pair of over-the-ear headphones consisting of a headband, padded ear covers, and anodized aluminum ear pieces with are inserted in the external ear canal. The device contains an accompanying unit for device control and a mains power supply.
Technical Method
The device produces a regulated thermal waveform which provides simultaneous heating in one ear and cooling in the other ear. The controlled temperature changes activate the vestibular system.
Target Area
The device is used in the external ear canals to stimulate the vestibular system.
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5893
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.5893 Thermal vestibular stimulator for headache

§ 882.5893 Thermal vestibular stimulator for headache.

(a) 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.

(b) 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.

[83 FR 52973, Oct. 19, 2018]

Thermal Vestibular Stimulator For Headache

Page Type
Product Code
Definition
The device is intended to stimulate the vestibular system using thermal waveforms in the ear canals for treatment of migraine headache.
Physical State
The device resembles a pair of over-the-ear headphones consisting of a headband, padded ear covers, and anodized aluminum ear pieces with are inserted in the external ear canal. The device contains an accompanying unit for device control and a mains power supply.
Technical Method
The device produces a regulated thermal waveform which provides simultaneous heating in one ear and cooling in the other ear. The controlled temperature changes activate the vestibular system.
Target Area
The device is used in the external ear canals to stimulate the vestibular system.
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5893
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.5893 Thermal vestibular stimulator for headache

§ 882.5893 Thermal vestibular stimulator for headache.

(a) 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.

(b) 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.

[83 FR 52973, Oct. 19, 2018]