21 CFR 882.5894 — Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch
Neurology (NE) · Part 882 Subpart F—Neurological Therapeutic Devices · § 882.5894
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.
Classification Rationale
Class II (special controls). The special controls for this device are:
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| OSG | Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch | 2 | 2 |
Special Controls
OSG — Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch
In combination with the general controls of the FD&C Act, the Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites is subject to the following special controls: - 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: - a. Validated instructions which addresses the following: - i. Identification of areas of the body which are appropriate and not appropriate for contact with the device; - ii. Whether use of the device in conjunction with flammable materials (e.g., insect repellent) is appropriate; - iii. Use of the device on or near implanted devices; - iv. How to identify the correct type of skin condition - b. Technical parameters of the device [maximum output voltage (instantaneous), maximum output current (instantaneous), and pulse duration]. - Language to direct end-users to contact the device manufacturer and MedWatch if C. they experience any adverse events with this device. - d. The anticipated number of device uses prior to failure.
De Novo Order DEN100024
OSG — Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch
In combination with the general controls of the FD&C Act, the Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites.is subject to the following special controls: - 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: - a. Validated instructions which addresses the following: - i. Identification of areas of the body which are appropriate and not appropriate for contact with the device; - ii. Whether use of the device in conjunction with flammable materials (e.g., insect repellent) is appropriate; - iii. Use of the device on or near implanted devices; - iv. How to identify the correct type of skin condition - b. Technical parameters of the device [maximum output voltage (instantaneous), maximum output current (instantaneous), and pulse duration]. - c. Language to direct end-users to contact the device manufacturer and MedWatch if they experience any adverse events with this device. - d. The anticipated number of device uses prior to failure.
De Novo Order DEN130019
OSG — Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch
*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.
eCFR
OSG — Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch
(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.
Ecfr Llm
