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Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch

Page Type
Product Code
Definition
Relief / Reduction of Mosquito Bite Itch
Physical State
The device is hand-held, composed of an insulated housing which contains a piezo-electric crystal and conductive elements to deliver charge to the skin, as well as a moving mechanical part to allow the intended user to generate the force to produce the electrical charge.
Technical Method
Electrical charge, generated via piezo-electric crystal, delivered transcutaneously at the site of the mosquito bite. The piezo-electric crystal generates electrical charge by the application of a manual mechanical force.
Target Area
Intended to be placed on the skin, at the site of a mosquito bite.
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
882.5894
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

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

§ 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.

[80 FR 15165, Mar. 23, 2015]

Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch

Page Type
Product Code
Definition
Relief / Reduction of Mosquito Bite Itch
Physical State
The device is hand-held, composed of an insulated housing which contains a piezo-electric crystal and conductive elements to deliver charge to the skin, as well as a moving mechanical part to allow the intended user to generate the force to produce the electrical charge.
Technical Method
Electrical charge, generated via piezo-electric crystal, delivered transcutaneously at the site of the mosquito bite. The piezo-electric crystal generates electrical charge by the application of a manual mechanical force.
Target Area
Intended to be placed on the skin, at the site of a mosquito bite.
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
882.5894
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

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

§ 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.

[80 FR 15165, Mar. 23, 2015]