The EEG NeuroAmp is intended for biofeedback and relaxation purposes. To perform its intended function it must be used in combination with a computer and appropriate software.

For purposes of this training task, information for feedback may be derived from one or two channels of EEG and from as many as three channels of peripheral physiology measures such as are conventionally used in biofeedback.

The EEG NeuroAmp is intended to be used in the office by trained professionals who can ensure sound handling practices.

The EEG NeuroAmp is not intended for diagnostic purposes.

Device Description

The purpose of the EEG NeuroAmp is to act as user-friendly high-performance interface between client and clinician computer for EEG biofeedback) and/or peripheral biofeedback therapy. The EEG NeuroAmp contains four function blocks:

1. EEG amplifier, two channels, aligned and high-resolution
1. Built-in impedance meter for five electrodes helps achieve good electrode contact and warns if electrodes are worn out
1. Peripheral sensor amplifiers, three channels, allow measurement of peripheral biofeedback signals such as GSR (Galvanic Skin Response) and temperature. The latter may be by means of a contact probe (thermistor) or non-contact infrared thermal sensor (infrared thermometer).
1. An output for audio/visual/tactile feedback

AI/ML Overview

The Corscience GmbH & Co. KG EEG NeuroAmp is a biofeedback device intended for biofeedback and relaxation purposes.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to predicate devices and compliance with relevant standards. It does not explicitly define "acceptance criteria" in terms of specific performance metrics for the overall device's therapeutic effectiveness (e.g., a percentage reduction in a particular symptom). Instead, the acceptance is based on meeting safety and technical standards and demonstrating comparable performance to predicate devices for its intended use.

However, some technical specifications can be viewed as performance characteristics that were likely expected to meet certain thresholds or be comparable to predicate devices.

Parameter	Acceptance Criteria (Implied by Predicate/Standards)	Reported Device Performance (EEG NeuroAmp)
Intended Use	Biofeedback and relaxation purposes. Must be used with computer and software. Data from 1-2 EEG channels and up to 3 peripheral physiology measures. For use by trained professionals in an office setting. Not for diagnostic purposes.	The EEG NeuroAmp is intended for biofeedback and relaxation purposes. To perform its intended function it must be used in combination with a computer and appropriate software (Cygnet). For purposes of this training task, information for feedback may be derived from one or two channels of EEG and from as many as three channels of peripheral physiology measures such as are conventionally used in biofeedback. The EEG NeuroAmp is intended to be used in the office by trained professionals who can ensure sound handling practices. The EEG NeuroAmp is not intended for diagnostic purposes.
Power Supply	Acceptable and safe power source.	Power supply via USB port (galvanic isolation according to IEC 60601-1).
Software	Functional and appropriate for biofeedback.	Cygnet
No. of Input Channels	Comparable to predicate devices (BrainMaster had 2, ProComp had 8).	5
No. of Output Channels	Comparable to predicate devices (Predicates had 0).	1
ADC Resolution	Comparable to predicate devices (BrainMaster 8 bit, ProComp 14 bit).	13 bit
Anti-aliasing Filter	Present for effective signal processing.	5th order Butterworth
DC Gain Accuracy	Comparable to predicate devices (BrainMaster ±5%, ProComp ±0.5%).	±1%
DC Offset	Comparable to predicate devices (BrainMaster +4 LSB, ProComp +3 LSB).	+1 LSB
Bandwidth (3dB) & Sample Rate	Appropriate for EEG and peripheral biofeedback.	EEG amplifier (2 channels): 0.08 Hz (1st order roll-off) ...70 (5th order roll-off). Sample rate for 50Hz line: 1000 sps. Sample rate for 60Hz line: 960 sps. Subsample rate = sample rate / 4 (250/240). Peripheral Amplifier (3 channels): DC ... 10Hz. Same sampling rate scheme.
Full-scale Input Range, DC	Appropriate for biofeedback signals.	± 250 mV
Overvoltage Warning	Desirable for safety (ProComp/BrainMaster lacked this).	Yes
Impedance Measurement	Ability to check electrode contact quality.	Both channels simultaneously; displayed by colored LED bars on device. Needs to be engaged explicitly, disabled during EEG neurofeedback.
CMRR - EEG sensor only	High common-mode rejection for signal quality (>100 dB for BrainMaster, >130 dB for ProComp).	>130 dB
Temperature Range (pIRx3 accessory)	Suitable for forehead temperature measurement.	29°C - 43°C or 84°F - 109°F
Accuracy (pIRx3 accessory)	Accurate enough for biofeedback (ProComp ±1.0°C).	< 1°K
Safety and EMC (Electrical Medical Safety)	Compliance with IEC 60601-1 and IEC 60601-1-2.	Full compliance demonstrated by accredited laboratories. Galvanically isolated from computer by medical grade isolating transformer.
Software Validation	Validated for intended function.	Tested as described in section 16 "Software" (details not provided in the excerpt).
Biocompatibility	Compliance with ISO 10993-1 for patient-contacting parts.	Housing material passed all tests for ISO 10993-1. Elastic belt: conforms to German "Oko-Tex-Standard," passed dermal irritation and sensitization tests, but did not pass cytotoxicity due to cotton material and is suitable for use on intact skin only (implies an acceptance of this limitation).

Study Proving Acceptance Criteria are Met:

The document describes a series of tests and comparisons to predicate devices to demonstrate substantial equivalence and safety rather than a single "study" proving therapeutic effectiveness against pre-defined clinical acceptance criteria.

The primary "study" or demonstration of meeting acceptance criteria consists of:

Bench Testing and Compliance with Standards: The EEG NeuroAmp and its accessory were tested according to international standards for electrical medical devices and biocompatibility.
Comparison to Predicate Devices: A detailed comparison table (Section 5.12) is provided, highlighting the similarities in intended use and technical specifications, and justifying any differences.

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: The document does not refer to a "test set" in the context of patient data or clinical outcomes. The testing primarily involved bench testing of the device's hardware and software against technical specifications and safety standards. There is no indication of patient data being used for device performance evaluation.
Data Provenance: Not applicable, as there is no patient data described as part of the performance evaluation. The data provenance described relates to manufacturing standards and regulatory compliance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Ground Truth Experts: Not applicable in the context of clinical ground truth. The "ground truth" for the device's acceptable performance was established by its compliance with recognized international standards (IEC 60601-1, IEC 60601-1-2, ISO 10993-1) and comparison to the technical specifications of legally marketed predicate devices. The experts involved would be engineers and testing personnel at accredited laboratories. Their qualifications are implicitly that they are subject matter experts in the respective testing domains (e.g., electrical safety, EMC, biocompatibility).

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. There was no clinical data requiring expert adjudication. Device performance was assessed against technical specifications and regulatory standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

MRMC Study: No. This device is a biofeedback device, not an AI-powered diagnostic or assistive tool for human readers. No MRMC comparative effectiveness study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Standalone Performance: Not applicable in the context of an algorithm's diagnostic performance. The device's "standalone" performance refers to its ability to accurately measure and process physiological signals according to its technical specifications, which was assessed through bench testing and compliance with standards. The device itself is an interface and amplifier, and its function is to provide accurate data to the clinician's software, which is then used in a human-in-the-loop biofeedback process.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Type of Ground Truth: The ground truth used was technical specifications, international safety standards, and performance characteristics of legally marketed predicate devices. For example, a specified gain accuracy of ±1% or a CMRR of >130 dB would be the "ground truth" to which the device's measured performance was compared during testing.

8. The sample size for the training set:

Training Set Sample Size: Not applicable. This device is a hardware biofeedback system, not an AI/ML algorithm that requires a training set of data.

9. How the ground truth for the training set was established:

Ground Truth for Training Set: Not applicable. As there is no AI/ML algorithm involved, there is no training set or ground truth for such a set.

Summary

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Title	Premarket Notification for EEG NeuroAmp
Document Name	NeuroAmp_510(k).doc
Issue	1.1
Date	Feb.06.2008
	Corscience GmbH & Co. KG

K073557

510(K) SUMMARY 5

General Information

Applicant 5.1

Date: February 06, 2008

Corscience GmbH & Co. KG Name:
Address: Henkestr. 91 D-91052 Erlangen Germany

Contact person in the U.S.:

Address

Telephone: FAX: E-Mail:

Contact person in Germany: Telephone: FAX: E-Mail:

Patrik R. Karem

SOMNO TECH, L.L.C. 700-706 Seco Rd. Monroeville, PA 15146 412 - 372 - 8571 412 — 372 — 8575 rpkarem@somnotech.com

Christine Baumann 01149 9131 977986 – 25 01149 9131 977986 - 59 baumann@corscience.de

Signature: C. Baumann

5.2 Trade Name

EEG NeuroAmp

5.3 Common Name or Classification Name

Biofeedback device

5.4 Establishment Registration Number

3005488716

FEB 28 2003

{1}------------------------------------------------

Title	Premarket Notification for EEG NeuroAmp
Document Name	NeuroAmp_510(k).doc
Issue	1.1
Date	Feb.06.2008
	Corscience GmbH & Co. KG

Facility Address 5.5

Corscience GmbH & Co. KG Henkestr. 91 D-91052 Erlangen Germany

5.6 Device Classification

5.6.1 Classification

This is a class II device

5.6.2 Classification panel

Panel: neurology Product Code HCC

5.6.3 Regulation Number

882.5050

5.7 Reason for Premarket Notification

Approval of biofeedback device and computer software. Included in this premarket notification is the peripheral temperature sensor plRx3 as optional accessory. This sensor measures forehead temperature and thus supports conventional thermal biofeedback.

The device has been exempt, but is not any longer because power supply is changed from batterysupply to supply via serial (USB-) port of the therapist computer.

5.8 Predicate Devices Descriptions

Names 5.8.1

ProComp BrainMaster

5.8.2 Predicate Device Companies

Thought Technology Ltd., Montreal, Canada BrainMaster Technologies, Inc., Oakwood Village, OH 44146, formerly: Cleveland, OH 44124

5.8.3 Predicate Device 510(k)#

ProComp: K903497 BrainMaster: K990538

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Title	Premarket Notification for EEG NeuroAmp
Document Name	NeuroAmp_510(k).doc
Issue	1.1
Date	Feb.06.2008
	Corscience GmbH & Co. KG

Device Description 5.9

1. EEG amplifier, two channels, aligned and high-resolution
1. Built-in impedance meter for five electrodes helps achieve good electrode contact and warns if electrodes are worn out
1. Peripheral sensor amplifiers, three channels, allow measurement of peripheral biofeedback signals such as GSR (Galvanic Skin Response) and temperature. The latter may be by means of a contact probe (thermistor) or non-contact infrared thermal sensor (infrared thermometer).
1. An output for audio/visual/tactile feedback

EEG NeuroAmp provides the following characteristics:

. Easy to use
Power supply via serial PC-port .
Impedance Meter: .
- Wide impedance range
- Cancellation of electrode galvanic voltages
- Cancellation of power line pick-up (notch filters)
- Bright easy-to-read LED bar display
- Balance display for optimum EEG signal noise reduction
EEG Amplifier .
- Low-noise, quasi DC coupled
- Fast settling time
- High-performance filters for optimum anti-aliasing
Peripheral Sensor Interface .
- Supply of power for active sensors
- High performance filters for optimum noise suppression
. Optional peripheral temperature sensor pIRx3 as accessory
. Audio/Visual/Tactile Output
- DC -2.5 to +2.5V
- AC 1 ... 250Hz, max 5Vss

User manuals with detailed descriptions of NeuroAmp, computer software Cygnet, and optional accessory plRx3 are submitted in section 13 "Proposed Labeling".

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Title	Premarket Notification for EEG NeuroAmp
Document Name	NeuroAmp_510(k).doc
Issue	1.1
Date	Feb.06.2008
	Corscience GmbH & Co. KG

5.10 Intended Use Statement

The EEG NeuroAmp is intended for biofeedback and relaxation purposes. To perform its intended function it must be used in combination with a computer and appropriate software.

The EEG NeuroAmp is intended to be used in the office by trained professionals who can ensure sound handling practices.

The EEG NeuroAmp is not intended for diagnostic purposes.

5.11 Required Components

EEG NeuroAmp .
Software Cygnet .
. User manuals

Optional accessory

Passive infrared temperature sensor pIRx3 .
. User manual for plRx3

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Title	Premarket Notification for EEG NeuroAmp
Document Name	NeuroAmp_510(k).doc
Issue	1.1
Date	Feb.06.2008
	Corscience GmbH & Co. KG

5.12 Summary Table of Comparisons

Parameter	EEG NeuroAmp	Predicate DeviceProComp	Predicate DeviceBrainMaster 2E
Intended Use	The EEG NeuroAmp isintended for biofeedback andrelaxation purposes. Toperform its intended functionit must be used incombination with a computerand appropriate software(Cygnet).For purposes of this trainingtask, information forfeedback may be derivedfrom one or two channels ofEEG and from as many asthree channels of peripheralphysiology measures suchas are conventionally used inbiofeedback.The EEG NeuroAmp isintended to be used in theoffice by trainedprofessionals who canensure sound handlingpractices.The EEG NeuroAmp is notintended for diagnosticpurposes.	Biofeedback, relaxationand muscle re-educationpurposes.	The Brainmaster 2E isindicated for relaxationtraining using alpha EEGBiofeedback. In theprotocol for relaxation,Brainmaster provides avisual and/or auditorysignal that correspondsto the patient's increasein alpha activity as anindicator of achieving astate of relaxation.
Power supply	Power supply via USB port(galvanic isolation accordingto IEC 60601-1)	4 AA batteries, single-useor rechargeable	Rechargeable batteries
Software	Cygnet	Biograph	BMT
No. of input channels	5	8	2
No. of outputchannels	1	0	0
ADC resolution	13 bit	14 bit	8 bit
Anti-aliasing filter	5th order Butterworth	5th order Butterworth	none
DC gain accuracy	±1%	±0.5%	±5%
DC offset	+1 LSB	+3 LSB	+4 LSB
Parameter	EEG NeuroAmp	Predicate DeviceProComp	Predicate DeviceBrainMaster 2E
Bandwidth (3dB) andsample rate	EEG amplifier(2 channels):0.08 Hz (1st order roll-off)...70 (5th order roll-off)Sample rate for 50Hz line:1000 spsSample rate for 60Hz line:960 spsSubsample rate = samplerate / 4 (250/240)Peripheral Amplifier(3 channels):DC ... 10HzSame sampling rate scheme	DC - 512Hz @ 2048samples/secondDC - 64Hz @ 256samples/secondDC - 64Hz @ 200samples/secondDC - 8Hz @ 32samples/secondDC - 8Hz @ 20samples/second(depending on channel)	0.8 - 40 Hz120 sps
Full-scale inputrange, DC	$\pm$ 250 mV	2.8V ± 1.696V	±0.8 V
Overvoltage warning	yes	no	no
Impedancemeasurement EEGelectrodes(electrode contactquality)	Both channelssimultaneously; displayed bycolored LED bars on device	One channel after theother; displayed only on thesoftware	No impedancemeasurement
Common-ModeRejection Ratio(CMRR) - EEGsensor only	>130 dB	> 130 dB	> 100 dB
Temperaturesensor (Accessory)
Temperature range	29°C - 43°C or 84°F - 109°F	10°C - 45°C (50°F - 115°F)	n.a.
Accuracy	< 1°K	±1.0°C (±1.8°F) at20°C - 40°C (68°F - 104°F)	n.a.

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Title	Premarket Notification for EEG NeuroAmp
Document Name	NeuroAmp_510(k).doc
Issue	1.1
Date	Feb.06.2008
	Corscience GmbH & Co. KG

All three devices are intended for EEG biofeedback (neurofeedback). EEG biofeedback is a process that is intended to help the client to control his own state through shaping electrical brain activity in a manner that promotes a state of relaxed alertness. The NeuroAmp and the predicate device Procomp can also be used with other conventional biofeedback sensors. ProComp can be operated with a wider range of sensors than the NeuroAmp, e.g. with sensors intended for performing muscle reeducation. Therefore, the intended use of the NeuroAmp does not include biofeedback for the purpose of muscle reeducation, as that term is conventionally understood (application to spinal cord injury, etc). On the other hand, simply training the person toward a relaxed and alert state also has implications for regulation of the motor system. A trainee is likely to also feel motorically calmed.

The differences in technological characteristics between EEG NeuroAmp and the predicate devices ProComp and Brainmaster can be summarized as follows:

Power supply via USB-port (5V) instead of battery supply (in the case of the Procomp) .

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Title	Premarket Notification for EEG NeuroAmp
Document Name	NeuroAmp_510(k).doc
Issue	1.1
Date	Feb.06.2008
	Corscience GmbH & Co. KG

Results of electrode contact measurement (impedance check) are displayed directly on the . device
The impedance measurement needs to be engaged explicitly, and is disabled during EEG . neurofeedback. This feature differentiates the EEG NeuroAmp from the current Brainmaster, where the impedance measurement is continuous throughout.
. The device monitors galvanic voltages throughout the training process.
The bandwidth extends to lower EEG frequencies. .
The temperature range of the pIRx3 is narrower than that of the Procomp temperature sensor, . but is totally sufficient for measuring forehead temperature.

The fact that the EEG NeuroAmp is powered via the serial port of the therapist computer does not affect safety or effectiveness because the device is galvanically isolated from the computer by means of a medical grade isolating transformer and has shown full compliance to IEC 60601-1.

Since qood electrode contact quality is essential for effective EEG-biofeedback therapy, the easy-touse impedance measurement function of the NeuroAmp contributes to clinical success.

The software provides for continuous monitoring of any 60-Hz contamination of the EEG, as an index to contact quality throughout the biofeedback process. The clinician is alerted on screen whenever criteria are violated.

The NeuroAmp extends the bandwidth to lower frequencies than typical EEG amplifiers because these have turned out to be of biological interest as well.

5.13 Summary of Device Testing

The EEG NeuroAmp and its optional accessory plRx3 have been tested according to IEC 60601-1 and IEC 60601-1-2 by accredited laboratories and have shown full compliance to these standards and the other standards listed in chapter 9 of this 510(k).

The software was tested as described in section 16 "Software".

The optional accessory "passive infrared temperature sensor plRx3" has been tested according to ISO 10993-1 by an FDA recognized testing laboratory according to GLP standards. The housing material and the elastic belt that fastens the device to the head have both been tested.

The elastic belt conforms to the German "Oko-Tex-Standard" which is a quality mark for clothing regarding certain residues. The belt is made of cotton and therefore did not pass the test for cytotoxicity. Due to this effect the belt is suitable for use on intact skin only. It did pass the tests for dermal irritation and sensitization. Normally, there is hair between the blient's skin, unless the client is bald.

The housing material has passed all tests. It shows full compliance to the standard 10993-1. See also section 15 "Biocompatibility".

5.14 Conclusions

Based on the above, Corscience GmbH & Co. KG concludes, that EEG NeuroAmp is substantially equivalent to legally marketed predicate devices and iffective for its intended use, and performs as well as or better than the predicate devices.

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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the head, body, and tail feathers.

Public Health Service

FEB 28 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Corscience GmbH & Co. KG % Ms. Christine Baumann Henkestrasse 91 91052 Erlangen GERMANY

Re: K073557

Trade/Device Name: EEG NeuroAmp Regulation Number: 21 CFR 882.5050 Regulation Name: Biofeedback Device Regulatory Class: Class II Product Code: HCC Dated: December 12, 2007 Received: December 19, 2007

Dear Ms. Baumann:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Ms. Christine Baumann

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N Wilkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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	CENTER FOR DEVICES AND RADIOLOGICAL HEALTH1 Page ODRH Home Page Search CDRH A-Z Index Con
	Indications for Use
<10/1) Number (if Imaism).

EEG NeuroAmp Device Name:

Indications for Use:

The EEG NeuroAmp is intended for biofeedback and relaxation purposes. To perform its intended function it must be used in combination with a computer and appropriate software.

The EEG NeuroAmp is intended to be used in the office by trained professionals who can ensure sound handling practices.

The EEG NeuroAmp is not intended for diagnostic purposes.

"Federal law restricts this device to sale by or on the order of a physician or any other practitioner licensed by the State in which he practices to use or order the use of the device."

Yes Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off Division of General, Restorative, and Neurological Devices

http://www.fda.gov/odrh/ode/indicate.html

510(k) Number

Regulation Number and Section

§ 882.5050 Biofeedback device.

(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.