QJQ · Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
Neurology · 21 CFR 882.5800 · Class 2
Overview
| Product Code | QJQ |
|---|---|
| Device Name | Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety |
| Regulation | 21 CFR 882.5800 |
| Device Class | Class 2 |
| Review Panel | Neurology |
Identification
A cranial electrotherapy stimulator is a prescription device that applies electrical current that is not intended to induce a seizure to a patient's head to treat psychiatric conditions.
Classification Rationale
Class II (special controls) when intended to treat insomnia and/or anxiety. Class III (premarket approval) when intended to treat depression.
Special Controls
In combination with the general controls of the FD&C Act, the virtual reality behavioral therapy device for pain relief is subject to the following special controls:
*Classification.* (1) Class II (special controls) when intended to treat insomnia and/or anxiety. The special controls for this device are:(i) A detailed summary of the clinical testing pertinent to use of the device to demonstrate the effectiveness of the device to treat insomnia and/or anxiety. (ii) Components of the device that come into human contact must be demonstrated to be biocompatible. (iii) The device must be designed and tested for electrical safety and electromagnetic compatibility (EMC) in its intended use environment. (iv) Appropriate software verification, validation, and hazard analysis must be performed. (v) The technical parameters of the device, including waveform, output mode, pulse duration, frequency, train delivery, maximum charge, and energy, must be fully characterized and verified. (vi) The labeling for the device must include the following: (A) The intended use population and the intended use environment; (B) A warning that patients should be monitored by their physician for signs of worsening; (C) A warning that instructs patients on how to mitigate the risk of headaches, and what to do should a headache occur; (D) A warning that instructs patients on how to mitigate the risk of dizziness, and what to do should dizziness occur; (E) A detailed summary of the clinical testing, which includes the clinical outcomes associated with the use of the device, and a summary of adverse events and complications that occurred with the device; (F) Instructions for use that address where to place the electrodes, what stimulation parameters to use, and duration and frequency of treatment sessions. This information must be based on the results of clinical studies for the device; (G) A detailed summary of the device technical parameters, including waveform, output mode, pulse duration, frequency, train delivery, and maximum charge and energy; and (H) Information on validated methods for reprocessing any reusable components between uses. (vii) Cranial electrotherapy stimulator devices marketed prior to the effective date of this reclassification must have an amendment submitted to the previously cleared premarket notification (510(k)) demonstrating compliance with these special controls. (2) Class III (premarket approval) when intended to treat depression. (c) Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before March 19, 2020, for any cranial electrotherapy stimulator device with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976, or that has, on or before March 19, 2020, been found to be substantially equivalent to any cranial electrotherapy stimulator device with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976. Any other cranial electrotherapy stimulator device with an intended use described in paragraph (b)(2) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
Recent Cleared Devices (19 of 19)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252951 | Genesis Sleep | Neurofield, Inc. | Dec 31, 2025 | SESE |
| K232253 | Modius Stress | Neurovalens Limited | Mar 27, 2024 | SESE |
| K230826 | Modius Sleep | Neurovalens , Ltd. | Oct 27, 2023 | SESE |
| K182311 | Cervella | Innovative Neurological Devices, LLC | Mar 7, 2019 | SESE |
| K090052 | CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C | Johari Digital Healthcare , Ltd. | May 29, 2009 | SESE |
| K070412 | ELEXOMA MEDIC | Redplane AG | May 21, 2008 | SESE |
| K062284 | CES ULTRA | Neuro-Fitness, LLC | Apr 5, 2007 | SESE |
| K060158 | NET-2000 MICROCURRENT STIMULATOR | Auri-Stem Medical, Inc. | Oct 13, 2006 | SESE |
| K024377 | TRANSCRANIAL ELECTROTHERAPY STIMULATOR-A, MODEL TESA-1 | Kalaco Scientific, Inc. | Jul 21, 2003 | SESE |
| K932050 | NH-2002 | New Horizon Health Care | Jun 5, 1995 | SESE |
| K910616 | LB-2000 CRANIAL ELECTROTHERAPY STIMULATOR | Life Balance Intl., Inc. | May 12, 1992 | SESE |
| K903014 | ALPHA-STIM CS | Electromedical Products, Inc. | May 12, 1992 | SESE |
| K903654 | LISS CRANIAL STIMULATOR MODEL SBL202-B | Medical Consultants Intl. , Ltd. | Oct 4, 1990 | SESE |
| K894515 | LISS CRANIAL STIMULATOR MODEL SBL201-M | Medical Consultants Intl. , Ltd. | May 3, 1990 | SESE |
| K895175 | NF-1 MINDPEACE | Neurofitness | Nov 8, 1989 | SESE |
| K894097 | NTI-1000 | Neurotek, Inc. | Sep 25, 1989 | SESE |
| K883812 | HP-1 (HEALTHPAX) | Healthdirections, Inc. | Nov 28, 1988 | SESE |
| K873920 | BR-2 BIOREST | Biorest, Inc. | Dec 29, 1987 | SN |
| K771534 | BIOTRON 18 | Biotronics Corp. | Aug 26, 1977 | SESE |
Top Applicants
- Medical Consultants Intl. , Ltd. — 2 clearances
- Auri-Stem Medical, Inc. — 1 clearance
- Biorest, Inc. — 1 clearance
- Biotronics Corp. — 1 clearance
- Electromedical Products, Inc. — 1 clearance
