(463 days)
No reference devices were used in this submission.
No
The device description and performance studies do not mention any AI or ML components. The device is described as a simple electrical muscle stimulator with manual controls.
Yes
The device is intended to improve or facilitate muscle performance through transcutaneous electrical muscle stimulation, which is a therapeutic purpose.
No
The device is intended to apply transcutaneous electrical muscle stimulation to improve or facilitate muscle performance, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines a physical, battery-operated, hand-held device with electrodes and mechanical components (axels, wheels, handle, knob, switch). It is not solely software.
Based on the provided information, the AK Body Toning Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to apply transcutaneous electrical muscle stimulation (EMS) to improve or facilitate muscle performance in healthy persons. This is a physical intervention applied to the body, not a test performed on samples taken from the body.
- Device Description: The device applies electrical stimulation through skin-contact electrodes. This is a direct interaction with the body.
- Lack of In Vitro Testing: The description does not mention any testing of samples (blood, urine, tissue, etc.) outside of the body.
- Performance Studies: The performance study involved observing muscle movement in vivo using ultrasound imaging, not analyzing samples in vitro.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The AK Body Toning Device does not fit this definition.
N/A
Intended Use / Indications for Use
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.
Product codes
NGX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdomen, thighs, and buttock
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/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 an abstract symbol that resembles a stylized human figure in profile, with three faces layered on top of each other.
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
1
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
2
Indications for Use
510(k) Number (if known) K152420
Device Name AK Body Toning Device
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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
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.
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.
4
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)† | Battery
3 x 1.5 V
AAA batteries | Rechargeable Ni-Mh
Battery 4.6V (4 cells
AA=R6) | |
| - Method of Line Current Isolation | N/A - Internal Power
Type BF | N/A (battery operated
device) | |
| - Patient Leakage Current†† | N/A (battery operated
device) | N/A (battery operated
device) | |
| - Normal Condition (μΑ) | N/A (battery operated
device) | N/A (battery operated
device) | |
| - Single Fault Condition (μΑ) | N/A (battery operated
device) | N/A (battery operated
device) | |
| Number of Output Modes††† | 1 | One (NMES) | |
| Number of Output Channels:†††† | Synchronous or
Alternating? | N/A Single channel. | |
| | Method of Channel
Isolation | N/A Single Channel | |
| | | 4
Synchronous, but never
2 channels activated at
the same time | |
| | | Each channel is the
middle of a H-Bridge.
Except when it is
activated, each channel
is always in high
impedance state | |
| Regulated Current or Regulated Voltage? | Voltage | Regulated current (all
channels) | |
| Parameter | AK Beauty Enterprises,
LLC | Compex Sport Plus | |
| Software/Firmware/Microprocessor
Control? | 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?
Yes
Low Battery?
No
Voltage/Current
Level?
Proportional Voltage level indicator | Yes
Yes
Yes, unit = [Energy] | |
| Timer Range (minutes) | 5 min | Maximum = 55 minute
Screen shows remaining
time in minutes and
seconds and displays
countdown 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 60601-1
IEC 60601-2-10 | |
| Compliance with 21 CFR 898? | N/A (electrodes are
integral with the device,
there are no separate
leads) | | |
| 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, rectified
sinusoidal) | Rectangular | Rectangular | |
| Maximum Output Voltage (volts) (+/-
10%) | 10.4 V @500Ω
35.6 V @ 2 kΩ
88.0 v @10 kΩ | 60 V @500Ω
165 V @ 2 kΩ
165 V @ 10 kΩ | |
| Maximum Output Current (specify units)
(+/- 10%) | 22 mA @500Ω
18 mA @ 2 kΩ | 120 mA
82 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 @ 500Ω
Excitation 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 @500Ω
0.0276 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 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. | The Compex® Sport Plus is
intended to stimulate
healthy muscles in order
to improve or facilitate
muscle performance. | |
5
6
7
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 ---