The AK Body Toning Device is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation (EMS) through skin-contact electrodes in order to improve or facilitate muscle performance.

Device Description

The AK Body Toning Device is a battery-operated, hand-held, single-program, muscle stimulation system to tone healthy muscles of the abdomen, thighs, and buttock. The device is self- contained with three rows of axels under a rounded unit with a handle that is shaped to allow a comfortable hand-grip for the user. Each axel has three knobbed wheels. The two sets of stainless on the ends are the powered electrodes and the middle set of plastic wheels allows for easier movement across the skin.

The device produces transcutaneous electrical muscle stimulation through the powered electrodes that are approximately four inches apart. An on-off switch applies the power and an adjustable knob sets the intensity of the treatment. An electroconductive gel is applied to the skin in the area to be treated and the device is rolled across the treatment area. The knob is adjusted until the treatment is effective and may be increased after initial use.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding the AK Body Toning Device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and performance metrics for a diagnostic or AI device. Therefore, much of the requested information regarding diagnostic accuracy, sample sizes for training/test sets, expert ground truth, and MRMC studies is not applicable or available in this document.

However, I can extract the information that is present and indicate where requested information is not provided.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for the device's intended use of improving or facilitating muscle performance. Instead, it focuses on demonstrating that the device performs similarly to the predicate device and meets safety standards.

Acceptance Criteria (Implicit)	Reported Device Performance
Functional Equivalence: Muscle stimulation similar to predicate device	Study: A study used ultrasound imaging to observe real-time muscle movement from stimulation of the anterior thigh muscle. Result: The muscle stimulation was similar for the AK Body Toning Device (both held stationary and rolled) and the predicate device.
Biocompatibility: Safe for skin contact	Testing: Biocompatibility evaluation conducted in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1. Result: Not explicitly stated as "passing" but implicitly found to be acceptable as part of the substantial equivalence determination.
Electrical Safety & EMC: Performs safely and meets standards	Testing: Performance and electrical safety testing conducted. Standards Met: IEC 60601-1, IEC 60601-1-2, UL 60601-1, CSA C22.2 No. 601.1, IEC 60601-2-10. Result: Test results demonstrate that the device safely performs as intended and raised no new questions of safety or performance compared to the predicate devices.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: The document does not specify the number of subjects or the sample size used in the muscle movement observation study.
Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided. The study involved direct observation of muscle movement, rather than interpretation of diagnostic images requiring expert ground truth in the traditional sense.

4. Adjudication method for the test set

This information is not applicable and not provided given the nature of the "muscle movement observation" study described.

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

This is not an AI device or a diagnostic imaging device, so an MRMC comparative effectiveness study involving human readers and AI assistance was not performed and is not applicable.

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

This is not an AI device, so a standalone algorithm performance study was not done and is not applicable.

7. The type of ground truth used

The "ground truth" for the muscle stimulation study was the direct observation of muscle movement via ultrasound imaging, compared between the investigational device and the predicate device. It's a direct physiological observation, not an expert consensus, pathology, or outcomes data in the typical sense of a diagnostic study.

8. The sample size for the training set

This is not an AI device, so there is no mention of a training set or its sample size.

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

This is not an AI device, so there is no mention of a training set or how its ground truth was established.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 1, 2016

AK Beauty Enterprises, LLC % Thomas C. Knott Senior Regulatory Advisor Benjamin L. England and Associates, LLC 810 Landmark Dr. Suite 126 Glen Burnie, Maryland 21061

Re: K152420

Trade/Device Name: AK Body Toning Device Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: October 29, 2016 Received: November 1, 2016

Dear Thomas C. Knott:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michae|J. Hoffmann -A

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152420

Device Name AK Body Toning Device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary (21 CFR 807.92)

l. SUBMITTER

AK Beauty Enterprises, LLC 436 North Bedford Dr. Suite 203 Beverly Hills, CA 90210

Phone: (310) 550-7747 Fax: (310) 550-8822

Contact Person: Robert Applebaum, MD Date Prepared: August 20, 2015

II. DEVICE

Name of Device: AK Body Toning Device Common or Usual Name: Muscle Stimulation Device Classification Name: Powered Muscle Stimulator for Muscle Conditioning Regulatory Class: 21 CFR 890.5850, Class II Product Code: NGX

lll. PREDICATE DEVICE

. K083140; Compex Sport Plus manufactured by DJO, LLC
These predicates have not been subject to a design-related recall. 2

No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

The AK Body Toning Device is intended to for use by healthy persons to apply transcutaneous electrical muscle stimulation (EMS) through skin-contact electrodes in order to improve or facilitate muscle performance.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

1 On July 9, 2012, section 605 of FDASIA (Pub. L. 112-144) added section 518A to the FD&C Act, which directs FDA to establish a program to routinely and systematically assess information regarding device recalls, and to use that information to proactively identify strategies for mitigating health risks presented by defective or unsafe devices. FDA believes that one way to carry out this directive is to provide greater transparency on recalled devices. Identifying whether a predicate was recalled is optional, but doing so would help the Agency achieve this FDASIA directive.

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The AK Body Toning Device is substantially equivalent to other legally marketed muscle stimulation devices cleared under product code NGX. The intended use of the AK Body Toning Device is the same as the predicate devices. All are intended for use on healthy muscles to improve muscle tone and are not intended to treat any diseases and are contraindicted for use on unhealthy muscles.

The AK Body Toning Device uses the same electrical stimulation principals as the predicate device. The AK Body Toning Device delivers the stimulation through rolling electrodes versus fixed electrodes in the predicate devices. However, the basic unit characteristics and output specifications of the AK Body Toning Device are substantially equivalent to the predicate devices. The rolling electrodes do not raise any new questions of safety or effectiveness. On the other hand, because the electrodes are moved across the treatment area and do not stay in one place, the AK Body Toning Device provides and extra measure of safety from consequences like skin burns, while effectively delivering electrical stimulation to a broader area during a treatment session. Thus, the AK Body Toning Device is substantially equivalent to existing predicate devices with the NGX product code.

Parameter	AK Beauty Enterprises,LLC	Compex Sport Plus
BASIC UNIT CHARACTERISTICS
510(k) Number	K152420	K083140
Device Name and Model	AK Body Toning Device	Compex Sport Plus
Manufacturer	AK Beauty Enterprises,LLC	DJO LLC
FDA Product Code	NGX	NGX
Power Source(s)†	Battery3 x 1.5 VAAA batteries	Rechargeable Ni-MhBattery 4.6V (4 cellsAA=R6)
- Method of Line Current Isolation	N/A - Internal PowerType BF	N/A (battery operateddevice)
- Patient Leakage Current††	N/A (battery operateddevice)	N/A (battery operateddevice)
- Normal Condition (μΑ)	N/A (battery operateddevice)	N/A (battery operateddevice)
- Single Fault Condition (μΑ)	N/A (battery operateddevice)	N/A (battery operateddevice)
Number of Output Modes†††	1	One (NMES)
Number of Output Channels:††††	Synchronous orAlternating?	N/A Single channel.
	Method of ChannelIsolation	N/A Single Channel
		4Synchronous, but never2 channels activated atthe same time
		Each channel is themiddle of a H-Bridge.Except when it isactivated, each channelis always in highimpedance state
Regulated Current or Regulated Voltage?	Voltage	Regulated current (allchannels)
Parameter	AK Beauty Enterprises,LLC	Compex Sport Plus
Software/Firmware/MicroprocessorControl?	No	Yes
Automatic Overload Trip?	No	Yes
Automatic No-Load Trip?	No	Yes
Automatic Shut Off?	Yes	"On/Off" switch
User Override Control?	Yes	Yes
Indicator Display:	On/Off Status?YesLow Battery?NoVoltage/CurrentLevel?Proportional Voltage level indicator	YesYesYes, unit = [Energy]
Timer Range (minutes)	5 min	Maximum = 55 minuteScreen shows remainingtime in minutes andseconds and displayscountdown timer
Compliance with Voluntary Standards?	-IEC 60601 1: 2005 +CORR. 1 (2006) + CORR.2 (2007) + AM1 (2012)-IEC 60601-1-2:2007(Third Edition)-UL 60601-1 (2003)CSA C22.2 No. 601.1(2003)-IEC 60601-2-10: 2012(Second Edition)	IEC 60601-1IEC 60601-2-10
Compliance with 21 CFR 898?	N/A (electrodes areintegral with the device,there are no separateleads)
Weight (Ibs., oz.)	800 g	300 [g]
Dimensions (in.) [W x H x D]	3.12 x 3.51x 7.0 (IN)	99 x 142 x 36 [mm]3.9 x 5.6 x 1.4 [in]
Housing Materials and Construction	ABS
OUTPUT SPECIFICATIONS
Mode or Program Name
Waveform (e.g., pulsed monophasic,biphasic)	Monophasic	Symmetrical Biphasic
Shape (e.g., rectangular, spike, rectifiedsinusoidal)	Rectangular	Rectangular
Maximum Output Voltage (volts) (+/-10%)	10.4 V @500Ω35.6 V @ 2 kΩ88.0 v @10 kΩ	60 V @500Ω165 V @ 2 kΩ165 V @ 10 kΩ
Maximum Output Current (specify units)(+/- 10%)	22 mA @500Ω18 mA @ 2 kΩ	120 mA82 mA @ 2 kΩ
Parameter		AK Beauty Enterprises, LLC	Compex Sport Plus
Duration of primary (depolarizing) phase† (µsec)		9 mA @10 kΩ	16 mA @ 10 kΩ
Max Pulse Duration† (µsec)		1000 µsec	800 µsec
Frequency† (Hz) [or Rate† (pps)]		75 Hz	1 - 120 Hz
For interferential modes only: Beat Frequency† (Hz)		N/A
For multiphasic waveforms only:	Symmetrical phases?	N/A (not multiphasic)	Symmetrical, 400 µsec ea phase
	Phase Duration† (include units),
	(state range, if applicable),
	(both phases, if asymmetrical)
Net Charge (microcoulombs (µC) per pulse) (If zero, state method of achieving zero net charge.)		22.5 µC @500Ω	0 µC @ 500ΩExcitation pulse fully compensated
Maximum Phase Charge, (µC)		22.5 µC @500Ω	48 [µC] @ 500Ω
Maximum Current Density,†† (mA/cm², r.m.s.)		4.17 mA/cm² @500Ω ?	1.49 mA/cm² @ 500Ω
Maximum Average Power Density,†† (W/cm²), (using smallest electrode conductive surface area)		0.0089W/cm² @ 500Ω	27.6 mW/cm² @500Ω0.0276 W/cm² @ 500Ω
Burst Mode†††	(a) Pulses per burst	N/A, no burst mode
(i.e., pulse trains):	(b) Bursts per second
	(c) Burst duration (seconds)
	(d) Duty Cycle: Line (b) x Line (c)
ON Time (seconds)
OFF Time (seconds)
Additional Features (specify, if applicable)		Electrodes are integrated within the unit
Parameter	AK Beauty Enterprises,LLC	Compex Sport Plus
Intended Use	The AK Body ToningDevice is intended to foruse by healthy personsto apply transcutaneouselectrical musclestimulation (EMS)through skin-contactelectrodes in order toimprove or facilitatemuscle performance.	The Compex® Sport Plus isintended to stimulatehealthy muscles in orderto improve or facilitatemuscle performance.

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VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Performance testing

A study observed muscle movement by ultrasound imaging. Real-time stimulation of the anterior thigh muscle was recorded using the AK device (while being held stationary and while being rolled) and the predicate device. The muscle stimulation was similar for the AK Body Toning Device and the predicate device.

Biocompatibility testing

The biocompatibility evaluation for the skin contact materials used in the AK Body Toning Device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.

Electrical safety and electromagnetic compatibility (EMC)

Performance and electrical safety testing were conducted on the AK Body Toning Device. The test results demonstrate that the device safely performs as intended and raised no new questions of safety or performance compared to the predicate devices. Internationally recognized standards include:

. IEC 60601 1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012)
. IEC 60601-1-2:2007 (Third Edition)
UL 60601-1 (2003)
. CSA C22.2 No. 601.1 (2003)
IEC 60601-2-10: 2012 (Second Edition) ●

VIII. CONCLUSIONS

The AK Body Toning Device is substantially equivalent the predicate device. They both are intended to stimulate healthy muscles to improve or facilitate muscle performance. They stimulate the muscles by delivering electrical current through electrodes to the skin to cause muscle contraction. The predicate is indicated for several muscle groups but the AK Body Toning Device is limited to the abdomen, buttocks and thighs. Their technological characteristics differ in that the AK Body Toning Device uses rolling electrodes but the predicate device uses fixed electrodes. The data indicates that the AK Body toning Device works as safely and effectively as the predicate device.

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--- END OF 510(K) SUMMARY ---

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).