(172 days)
No
The device description details a standard powered muscle stimulator with manual frequency adjustments and electrical safety testing. There is no mention of AI, ML, or any adaptive or learning capabilities.
No.
The intended use statement explicitly states, "The Body System is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind."
No
The "Intended Use / Indications for Use" states that the device is "intended for muscle conditioning to stimulate healthy muscles" and "is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind." This indicates a therapeutic or conditioning purpose, not a diagnostic one.
No
The device description explicitly details physical hardware components, including electrical components, casing, channel ports, pad applicators, transformers, amplifiers, and a power source. It also mentions testing related to electrical safety and electromagnetic compatibility, which are relevant to hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Body System Function: The Body System is a Powered Muscle Stimulator. It works by applying electrical currents to the body to stimulate muscles. It does not analyze any specimens taken from the body.
- Intended Use: The intended use is "muscle conditioning to stimulate healthy muscles," which is a physical intervention, not a diagnostic test.
- Device Description: The description focuses on electrical stimulation and its application via pads on the body. There is no mention of analyzing biological samples.
Therefore, based on the provided information, the Body System clearly falls outside the definition and function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Body System is intended for muscle conditioning to stimulate healthy muscles.
The Body System is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. The Body System is intended to be operated by a trained professional who is present to monitor treatment.
Product codes
NGX
Device Description
Body System (available in models: SX101 and OS2911). Both models utilize the same internal electrical components. The models differ only in the control/display features and exterior casing/dimensions. The Body System is a Powered Muscle Stimulator with 16 channel ports using self adhesive pad applicators attached to the body for muscle conditioning. The pad applicator is a 510K cleared device (K970426), itself.
The Body System uses the same technological characteristics as the predicate devices (listed below); it is an electrically powered device that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. The Body System muscle stimulators provide selections of different programs through manual adjustment of five different frequency programs of the device from 200 Hz, to 1250 Hz. The Body System has a maximum output voltage of 88V @ 2k Ohm, rated at 200 volts. A display shows the balance treatment time. The output signal is biphasic, rectangular and based on a voltage and current regulated technology. All channel outputs are isolated from each other; they have their own transformers and amplifiers which are Independent from neighboring channels or outputs. The only commonality between the outputs are their connectors to the power supply, the start button, the programs button, and the pulse button. The Body System power source is 110 V - 240 V AC Mains, 50-60 Hz. The patient leakage current tested at 240VAC 60Hz is 5 microamps for both the normal and fault conditions. The Body System Channels are synchronous and are isolated by separate transformers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
"The Body System is intended to be operated by a trained professional who is present to monitor treatment."
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)
Non-Clinical Tests
The Body System has been tested to establish is safety and performance.
The following tests have been performed on the patient contacting parts:
Device:
- Biocompatibility - Cytotoxicity (ISO-10993-5) - result: Pass
- Biocompatibility – irritation (ISO-10993-10) – result: Pass
- Biocompatibility - Sensitization (ISO-10993-10) - result: Pass
- Performance – including Output Waveforms of the Body System as compared to a predicate
- Electromagnetic Compatibility - according to EN 60601-1-2:2015, IEC 60601-1-2:2014, IEC 60601-2-10 2012 + A1 2016
- Electrical Safety – according to IEC 60601-1-6:2010, AMD1:2013, IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 26, 2019
A-1 Engineering % Peter Knauer Principal Consultant Sage BioPartners 1741 Little Kate Rd Park City, Utah 84060
Re: K182440
Trade/Device Name: Body System Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: November 26, 2018 Received: November 27, 2018
Dear Peter Knauer:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vivek J. Pinto -S
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) K182440
Device Name Body System
Indications for Use (Describe)
The Body System is intended for muscle conditioning to stimulate healthy muscles.
The Body System is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. The Body System is intended to be operated by a trained professional who is present to monitor treatment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Section 5. 510(k) Summary / Statement - 21 CFR 807.92(a)
This 510(k) Summary for the Body System is submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990 and follows the Office of Device Evaluation (ODE) guidance concerning the organization and content of a 510(k) Summary.
| Applicant Name: | A-1 Engineering |
|---|---|
| Applicant Address: | 30 Mauchly, Suite A |
| Irvine, CA 92618 | |
| Official Contact: | Tony Picciano, Owner |
| Telephone: | (949) 748-7488 |
| Email: | tony6213@yahoo.com |
| Submission Date: | November 26, 2018 |
| Subject Device: | Trade Name: Body System |
| Common Name: Muscle stimulator for conditioning. | |
| Regulation Description: | Powdered Muscle Stimulator |
| Classification: | Regulatory Class II, 21 CFR 890.5850 |
| Classification Name: | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Product Code: | NGX |
| Device Description | Body System (available in models: SX101 and OS2911). Both models |
| utilize the same internal electrical components. The models differ only in | |
| the control/display features and exterior casing/dimensions. The Body |
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System is a Powered Muscle Stimulator with 16 channel ports using self adhesive pad applicators attached to the body for muscle conditioning. The pad applicator is a 510K cleared device (K970426), itself.
The Body System uses the same technological characteristics as the predicate devices (listed below); it is an electrically powered device that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. The Body System muscle stimulators provide selections of different programs through manual adjustment of five different frequency programs of the device from 200 Hz, to 1250 Hz. The Body System has a maximum output voltage of 88V @ 2k Ω, rated at 200 volts. A display shows the balance treatment time. The output signal is biphasic, rectangular and based on a voltage and current regulated technology. All channel outputs are isolated from each other; they have their own transformers and amplifiers which are Independent from neighboring channels or outputs. The only commonality between the outputs are their connectors to the power supply, the start button, the programs button, and the pulse button. The Body System power source is 110 V - 240 V AC Mains, 50-60 Hz. The patient leakage current tested at 240VAC 60Hz is 5 microamps for both the normal and fault conditions. The Body System Channels are synchronous and are isolated by separate transformers.
The Intended Use of the Body System has the same key elements as the predicates: for muscle conditioning to stimulate healthy muscle. There are no differences in Intended Use amongst the predicates.
-
The Body System is intended for muscle conditioning to stimulate healthy Indications for use: muscles.
The Body System is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The Body Sy is intended to be operated by a trained professional who is present to monit treatment. -
Predicate Device: The Body System is substantially equivalent to the predicate devices listed below:
- . K123158, Ion Magnum Genius, under 21 CFR 890.5850 and Product Code NGX
Predicate Trade Name: Ion Magnum Genius
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Conditioning Premarket Notification: K123158 Manufacturer: Ion Genius, Inc. . K143551, Compex Wireless USA, under 21 CFR 890.5850 and Product Code NGX Predicate Trade Name: Compex Wireless USA Classification Name: Stimulator, Muscle, Powered for Muscle Conditioning Premarket Notification: K143551 Manufacturer: DJO, LLC Based on the intended use/Indications for use, design, materials, principle of operation, energy used and materials, the Body System is substantially equivalent to the legally marketed predicate devices. The non-clinical performance data demonstrates substantial equivalence and includes an analysis of output waveforms. Non-Clinical Tests The Body System has been tested to establish is safety and performance. Performed on the The following tests have been performed on the patient contacting parts: Device: ● Biocompatibility - Cytotoxicity (ISO-10993-5) - result: Pass . Biocompatibility – irritation (ISO-10993-10) – result: Pass ● Biocompatibility - Sensitization (ISO-10993-10) - result: Pass . Performance – including Output Waveforms of the Body System as compared to a predicate . Electromagnetic Compatibility - according to EN 60601-1-2:2015, IEC 60601-1-2:2014, IEC 60601-2-10 2012 + A1 2016 . Electrical Safety – according to IEC 60601-1-6:2010, AMD1:2013, IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) Summary: There are no differences in the technological characteristics between the subject device and the predicate devices, which raise issues concerning safety, performance or efficacy. The Body System is substantially equivalent to the predicate device(s) in terms of safety and effectiveness.
Classification Name: Stimulator, Muscle, Powered for Muscle
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| Comparison of the Subject and Predicate Devices | |||||
|---|---|---|---|---|---|
| Elements of | |||||
| Comparison | Subject device | Primary | |||
| Predicate Device | Secondary | ||||
| Predicate Device | Similar/Different | ||||
| Device Name and | |||||
| Model | Body System | Ion Magnum | |||
| Genius | Compex Wireless | ||||
| USA | N/A | ||||
| 510 (K) Number | Subject of this | ||||
| submission | K123158 | K143551 | N/A | ||
| Product Code | NGX | NGX | NGX | Similar | |
| Regulation | |||||
| Number | 890.5850 | 890.5850 | 890.5850 | Similar | |
| Indications for | |||||
| Use | The Body System | ||||
| is intended for | |||||
| muscle | |||||
| conditioning to | |||||
| stimulate healthy | |||||
| muscles. |
The Body System
is not intended to
be used in
conjunction with
therapy or
treatment of
medical diseases
or medical
conditions of any
kind. The Body
System is
intended to be
operated by a
trained
professional who
is present to
monitor
treatment. | Ion Magnum
Genius is
intended for
muscle
conditioning to
stimulate healthy
muscles. The Ion
Magnum Genius
is not intended to
be used in
conjunction with
therapy or
treatment of
medical diseases
or medical
conditions of any
kind. None of the
Ion Magnum
Genius programs
is designed for
injured or ailing
muscles and its
use on such
muscles is
contraindicated.
The Ion Magnum | The Compex
Wireless USA is an
Over-The-Counter
device intended
to stimulate
healthy muscles in
order to improve
or facilitate
muscle
performance. It is
to be used by
adults only.
The Compex
Wireless USA is
not intended for
adjunctive
therapy in the
treatment of
medical diseases
and conditions of
any kind. None of
the Compex
Wireless USA
stimulation
programs are
designed for
injured or disease
afflicted muscles.
Its use on such | Similar - although
there are some
differences in the
exact language of
each Intended
Use, each is
indicated for the
Stimulation of
Healthy Muscles | |
| Comparison of the Subject and Predicate Devices | | | | | |
| Elements of
Comparison | Subject device | Primary
Predicate Device | Secondary
Predicate Device | Similar/Different | |
| | | offered under
prescription given
by a physician
licensed in the
state in which he
or she practices. | contraindicated.
The work imposed
on the muscles by
the Compex
Wireless USA
programs is
definitely not
suitable for
rehabilitation and
physiotherapy.
The Compex
Wireless USA
electrical impulses
allow the
triggering of
action potentials
on motoneurones
of motor nerves
(excitations).
These excitations
of motoneurones
are transmitted to
the muscle fibers
via the motor
endplate where
they generate
mechanical
muscle fiber
responses that
correspond to
muscle work.
Depending on the
parameters of the
electrical impulses
(pulse frequency,
duration of
contraction,
duration of rest,
total session
duration),
different types of | | |
| Comparison of the Subject and Predicate Devices | | | | | |
| Elements of
Comparison | Subject device | Primary
Predicate Device | Secondary
Predicate Device | Similar/Different | |
| | | | be imposed on
the stimulated
muscles.
The Compex
Wireless USA may
therefore be
considered a
technique of
muscle training. | | |
| Body Application
Areas | Body | Body | Body | Similar | |
| Power Sources | 110vac — 240 vac
(AC wall plug-In) | 110vac — 240 vac
(AC wall plug-In) | Lithium Polymer
(LiPo)
rechargeable
batteries | Different -
differences do not
present different
questions of/or
effect safety and
effectiveness; the
similar currents
generated by
each channel and
applied to the
patient is isolated
from the power
source. | |
| Patient Leakage
Current | 0.05 µA and | 0.07 μΑ | N/A | Similar | |
| Number of
Output Modes for
Micro current
Stimulation | 5 | 3 | 1 | Different -
differences do not
present different
questions of/or
effect safety and | |
| Comparison of the Subject and Predicate Devices | | | | | |
| Elements of
Comparison | Subject device | Primary
Predicate Device | Secondary
Predicate Device | Similar/Different | |
| | | | | effectiveness; all
outputs meet the
requirements of
the FDA Guidance
on Powered
Muscle
Stimulators. | |
| Number of
Channels for
Micro current
Stimulation | 16 | 6 | 4 | Different -
differences do not
present different
questions of/or
effect safety and
effectiveness;; all
channels are
isolated and
generate the
identical signal,
which are similar
to the predicates. | |
| Channel Output:
Synchronous or
Alternating | Synchronous | Synchronous | Synchronous | Similar | |
| Channel Output:
Method of Line
Current Isolation | Power Supply
isolation | Power Supply
isolation | Power Supply
isolation | Similar | |
| Regulated
Current or
Regulated
Voltage | Both | Voltage | Both | Similar (voltage
regulated devices) | |
| Software/Firm
ware/Microproce
ssor control | No | No | Yes | Different -
differences do not
present different
questions of/or | |
| Comparison of the Subject and Predicate Devices | | | | | |
| Elements of
Comparison | Subject device | Primary
Predicate Device | Secondary
Predicate Device | Similar/Different | |
| | | | | effect safety and
effectiveness; the
similar currents
generated by
each unit is not
related to
software/
firmware. | |
| Automatic
Overload Trip | Yes | Yes | Yes | Similar | |
| Automatic No
load Trip | Yes | Yes | Yes | Similar | |
| Indicator Display:
On / Off Status | Yes | Yes | Yes | Similar | |
| Indicator Display:
Voltage Current
Level | Yes | Yes | Yes | Similar | |
| Timer Range | None | Yes | Yes | Similar | |
| Compliance with
Standards | Electrical Safety:
Comply with IEC
60601-1 and IEC
60601-2-10
EMC: Comply with
IEC 60601-1-2
Biocompatibility:
ISO10993-5 and
ISO10993-10 | Electrical Safety:
Comply with IEC
60601-1 and IEC
60601-2-10
EMC: Comply with
IEC 60601-1-2
Biocompatibility:
ISO10993-5 and
ISO10993-10 | Electrical Safety:
Comply with IEC
60601-1 and IEC
60601-2-10
EMC: Comply with
IEC 60601-1-2
Biocompatibility:
Unknown | Similar | |
| Compliance with
21 CFR 898 | Yes | Yes | Yes | Similar | |
| Comparison of the Subject and Predicate Devices | | | | | |
| Elements of
Comparison | Subject device | Primary
Predicate Device | Secondary
Predicate Device | Similar/Different | |
| Weight | See Section 11 for
weight of
individual models | 12.35 oz | Remote: 3.9 oz
Console:2x 2.1 oz
Docking Station
28.2 oz | Different -
differences do not
present different
questions of/or
effect safety and
effectiveness; the
similar currents
generated by
each unit is not
related to weight
of the unit. | |
| Dimensions | See Section 11 for
dimensions of
individual models | 5.6" x 3.9" x 1.4"
(L x W x H) | Remote
3.5"x1.8"x0.28"
Console:
2.6"x0.8"
Docking Station:
9.8"x9.8"x0.8" | Different -
differences do not
present different
questions of/or
effect safety and
effectiveness; the
similar current
generated by
each unit is not
related to size of
the unit. | |
| Housing
Materials and
Construction | Aluminum | Metal | Plastic | Different -
differences do not
present different
questions of/or
effect safety and
effectiveness; the
similar current
| |
| Comparison of the Subject and Predicate Devices | | | | | |
| Elements of
Comparison | Subject device | Primary
Predicate Device | Secondary
Predicate Device | Similar/Different | |
| | | Additional Information | | | |
| Waveform (see
Section 18 for
details) | Biphasic | Biphasic | Biphasic | Similar | |
| Shape | Rectangular | Rectangular | Rectangular | Similar | |
| Maximum Output
Voltage | 58V @ 500 Ω
88V @ 2k Ω | 50 V @ 500 Ω
200 V @ 10K Ω | 60 V @ 500 Ω
180V @ 2 kΩ
180 V @ 10 kΩ | Similar | |
| Maximum Output
Current | 108 ma at 500 Ω | 100 am at 500 Ω | 120 mA @ 500 Ω | Similar | |
| Frequency range | 200 to 1200 Hz | 90 to 120 Hz | 1 to 120 Hz | Similar | |
| Pulse width range | 500 to 2500 µsec | 416 to 500 µsec | 300 to 400 µsec | Similar | |
| Net Charge | 0 @ 500 Ω
Zero net charge is
achieved by using
symmetrical
biphasic
waveforms | 10000 µColumns
@ 500 Ω
4000 µColumns @
2K Ω
2500 µColumns @
10K Ω | 0 @ 500 Ω | Similar | |
| Maximum Phase
Charge | 45 µC @ 500 Ω @
200 Hz | 50 µC @ 500 Ω @
90 and 100 Hz
40 µC @ 500 Ω @
120 Hz | 48 µC @ 500Ω | Similar | |
| Comparison of the Subject and Predicate Devices | | | | | |
| Elements of
Comparison | Subject device | Primary
Predicate Device | Secondary
Predicate Device | Similar/Different | |
| Maximum
Current
Density | 5 mA / cm2 | 4 mA / cm2 | 1.49 mA/cm2 | Similar | |
| Maximum Power
Density | 0.011 W/cm^2 | 0.0012 W/cm^2 | 0.00276 W/cm^2 | Similar | |
| Environment for
operating | Temperature:
Approximately 15
to 40° C | Temperature:
Approximately 15
to 40° C | Unknown | Similar | |
| Environment
for storage | Temperature:
Approximately 20
to 60° C
Humidity:
Approximately 0
to
88% RH | Temperature:
Approximately 20
to 60° C
Humidity:
Approximately 0
to
88% RH | Unknown | Similar | |
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