Last synced on 23 September 2022 at 11:05 pm

Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine

Page Type
Product Code
Definition
A trunk and limb electrical stimulator to treat headache is a device intended to treat headache through the application of electrical stimulation anywhere on the body of the patient apart from the patient's head or neck through electrodes placed on the skin. The stimulation may be provided transcutaneously or percutaneously.
Physical State
Hardware with battery/electronics and electrodes residing in an band placed on an area other than the head. Bluetooth connection with a mobile application.
Technical Method
External electrical stimulation to create a perceptive sensation (non-painful)
Target Area
External (on the skin) of the limbs.
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5899
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.5899 Trunk and limb electrical stimulator to treat headache

§ 882.5899 Trunk and limb electrical stimulator to treat headache.

(a) Identification. A trunk and limb electrical stimulator to treat headache is a device intended to treat headache through the application of electrical stimulation anywhere on the body of the patient apart from the patient's head or neck through electrodes placed on the skin. The stimulation may be provided transcutaneously or percutaneously.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. This testing must include:

(i) Characterization of the electrical stimulation, including the following: Waveforms; output modes; maximum output voltage and maximum output current (at 500Ω, 2kΩ, and 10kΩ loads); pulse duration; frequency; net charge per pulse; and maximum phase charge, maximum current density, maximum average current, and maximum average power density (at 500Ω);

(ii) Characterization of the impedance monitoring system; and

(iii) Characterization of the electrode performance including the electrical performance, adhesive integrity, shelf-life, reusability, and current distribution of the electrode surface area.

(2) The patient-contacting components of the device must be demonstrated to be biocompatible.

(3) Performance testing must demonstrate electromagnetic compatibility and electrical, mechanical, and thermal safety in the intended use environment.

(4) Software verification, validation, and hazard analysis must be performed.

(5) Labeling must include the following:

(i) Instructions for use, including the typical sensations experienced during treatment;

(ii) A detailed summary of the electrical stimulation output, and the device technical parameters, including any wireless specifications;

(iii) A shelf life for the electrodes and reuse information; and

(iv) Instructions on care and cleaning of the device.

[86 FR 68401, Dec. 2, 2021]

Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine

Page Type
Product Code
Definition
A trunk and limb electrical stimulator to treat headache is a device intended to treat headache through the application of electrical stimulation anywhere on the body of the patient apart from the patient's head or neck through electrodes placed on the skin. The stimulation may be provided transcutaneously or percutaneously.
Physical State
Hardware with battery/electronics and electrodes residing in an band placed on an area other than the head. Bluetooth connection with a mobile application.
Technical Method
External electrical stimulation to create a perceptive sensation (non-painful)
Target Area
External (on the skin) of the limbs.
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5899
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.5899 Trunk and limb electrical stimulator to treat headache

§ 882.5899 Trunk and limb electrical stimulator to treat headache.

(a) Identification. A trunk and limb electrical stimulator to treat headache is a device intended to treat headache through the application of electrical stimulation anywhere on the body of the patient apart from the patient's head or neck through electrodes placed on the skin. The stimulation may be provided transcutaneously or percutaneously.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. This testing must include:

(i) Characterization of the electrical stimulation, including the following: Waveforms; output modes; maximum output voltage and maximum output current (at 500Ω, 2kΩ, and 10kΩ loads); pulse duration; frequency; net charge per pulse; and maximum phase charge, maximum current density, maximum average current, and maximum average power density (at 500Ω);

(ii) Characterization of the impedance monitoring system; and

(iii) Characterization of the electrode performance including the electrical performance, adhesive integrity, shelf-life, reusability, and current distribution of the electrode surface area.

(2) The patient-contacting components of the device must be demonstrated to be biocompatible.

(3) Performance testing must demonstrate electromagnetic compatibility and electrical, mechanical, and thermal safety in the intended use environment.

(4) Software verification, validation, and hazard analysis must be performed.

(5) Labeling must include the following:

(i) Instructions for use, including the typical sensations experienced during treatment;

(ii) A detailed summary of the electrical stimulation output, and the device technical parameters, including any wireless specifications;

(iii) A shelf life for the electrodes and reuse information; and

(iv) Instructions on care and cleaning of the device.

[86 FR 68401, Dec. 2, 2021]