(315 days)
No
The device description and performance studies focus on standard electrical stimulation technology and safety testing. There is no mention of AI/ML algorithms, training data, or performance metrics typically associated with AI/ML devices.
Yes
The intended use explicitly states "To be used to stimulate healthy muscles in order to improve and facilitate muscle performance," which describes a therapeutic action (improving performance). Additionally, the device type (muscle stimulator) and predicates are typically considered therapeutic.
No.
The device description and intended use clearly state that it is for stimulating healthy muscles to improve and facilitate muscle performance, not for diagnosis.
No
The device description explicitly details hardware components including an electronic stimulator module, a belt, electrode pads, and batteries. The performance studies also include testing related to hardware (biocompatibility, EMC, electrical safety).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "stimulate healthy muscles in order to improve and facilitate muscle performance." This is a therapeutic or performance-enhancing use, not a diagnostic one.
- Device Description: The device is an EMS (Electrical Muscle Stimulation) belt that applies electrical current to the skin to stimulate muscles. This is a physical intervention, not a test performed on biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a person's health status or disease.
- Performance Studies: The performance studies focus on biocompatibility, electrical safety, software validation, and electrode performance – all related to the physical function and safety of the device, not its ability to diagnose.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates in vivo (on the body) and is intended for muscle stimulation.
N/A
Intended Use / Indications for Use
To be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Product codes (comma separated list FDA assigned to the subject device)
NGX
Device Description
MC0485 EMS Belt is a one channel battery operated muscle stimulation system specifically designed to exercise the abdominal muscles. It is comprised of an electronic stimulator module for signal generation, a belt for fixation, and four electrode pads for signal connection to skin. The built-in electrode pads are located on the inner surface of the belt.
Power is derived from 3 batteries located in a compartment protected by a removable battery cover for the EMS Belt. There is no current passed from side to side. The user cannot access the wiring or connectors within the belt.
The stimulator sends gentle electrical current to targeted muscle area through the electrode pads placed on the skin. The parameters of the EMS Belt are controlled by the buttons on the controller and are displayed by the LCD on the controller. Its intensity level can be adjustable by user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal muscles
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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)
- Biocompatibility Testing: The biocompatibility evaluation for the body-contacting components of the EMS Belt was conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices –Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on June 16, 2016", as recognized by FDA. The battery of testing was performed to, and passed, including:
- ISO 10993-5:2009/(R)2014, Biological Evaluation of Medical Devices –Part 5: Tests for In Vitro Cytotoxicity
- ISO 10993-10:2010. Biological Evaluation of Medical Devices -Part 10: Tests for Irritation and Skin Sensitization
- EMC and Electrical Safety: EMC and Electrical safety testing was performed to, and passed, the following standards:
- IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
- IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-11 Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
- IEC 60601-2-10 Medical electrical equipment Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
-
Software Verification and Validation: Software documentation consistent with moderate level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
-
Other Performance Verification:
- The Electrode Pad Performance Test Report has been conducted to verify the current dispersion and shelf-life of the electrodes used by the subject device in the expiration date according to the requirements of the FDA Guidance -Shelf Life of Medical Device and ASTM F1980-07 Standard.
- The waveform and output test report has also been conducted to verify the output specifications of the subject device according to the FDA Guidance for Powered Muscle Stimulator 510(k)s.
Summary: Based on the above performance as documented in this application. EMS Belt was found to have a safety and effectiveness profile that is similar to the predicate device.
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.
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/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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 18, 2019
Dongguan Yingfeng Metal & Plastic Products Co., Ltd % Rain Yip Registered Engineer Feiying Drug & Medical Consulting Technical Service Group Rm. 3005, Area B, Bldg.1, Southward Ruifeng Business Center Guimiao Road Shenzhen, 518000 CN
Re: K183103
Trade/Device Name: EMS Belt (Model: MC0485) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: March 14, 2019 Received: August 15, 2019
Dear Rain Yip:
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.
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Vivek Pinto, PhD Director (Acting) DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183103
Device Name EMS Belt (Model MC0485)
Indications for Use (Describe)
To be used to stimulate healthy muscles in order to improve and 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
''510(k) Summary'' as required by 21 CFR Part 807.92.
Date: 2018-10-26
I. Submitter
Dongguan Yingfeng Metal & Plastic Products Co., Ltd Bianpu District, Lianhu Road, Qiaotou Town, Dongguan City, Guangdong Province, P.R.C
Tel.: +86 769 8334 9883 Tax: +86 769 8345 2882
Zesheng Chen Quality Manager Tel: +86 181 2287 9716 Email: guang@maxcare.com.cn
II. Device
Name of Device/Model: EMS Belt/MC0485 Common or Usual Name: Powered muscle stimulator Classification Name: Stimulator, Muscle, Powered, For muscle conditioning Regulatory Class: II Product Code: NGX Regulation Number: 21 CFR 890.5850
III. Predicate Device
The predicate devices are listed as below:
| Manufacturer | Predicate Device | 510(k) Number | Approval Date |
|---|---|---|---|
| Hivox Biotek Inc. | (Primary) HIVOX OTC | ||
| Electrical Stimulator/SEM44 | K171803 | Nov. 29, 2017 | |
| Shenzhen | |||
| OSTO | |||
| Technology Company | |||
| Limited | Health Expert Electronic | ||
| Stimulator/AST-300C and | |||
| AST-300D | K133929 | Nov. 12, 2014 | |
| Actegy, Ltd | Revitive IX (OTC)/RIX | K143207 | Mar. 23, 2015 |
Reference device(s):
| Manufacturer | Reference Device | 510(k) Number | Approval Date |
|---|---|---|---|
| -------------- | ------------------ | --------------- | --------------- |
4
| Manufacturer | Reference Device | 510(k) Number | Approval Date |
|---|---|---|---|
| EasyMed Instruments | |||
| Co., Ltd. | SmartTENS | K143430 | May 29, 2015 |
IV. Device Description
MC0485 EMS Belt is a one channel battery operated muscle stimulation system specifically designed to exercise the abdominal muscles. It is comprised of an electronic stimulator module for signal generation, a belt for fixation, and four electrode pads for signal connection to skin. The built-in electrode pads are located on the inner surface of the belt.
Power is derived from 3 batteries located in a compartment protected by a removable battery cover for the EMS Belt. There is no current passed from side to side. The user cannot access the wiring or connectors within the belt.
The stimulator sends gentle electrical current to targeted muscle area through the electrode pads placed on the skin. The parameters of the EMS Belt are controlled by the buttons on the controller and are displayed by the LCD on the controller. Its intensity level can be adjustable by user.
V. Indications for Use
To be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
VI. Comparison of Technological Characteristics With the Predicate Device
The EMS Belt is substantially equivalent to the predicated device based on intended use, design, specifications and performance. It raises no safety or efficacy concerns when compared to the predicate devices.
Information for predicate device was obtained from publicly available sources, including the 510(k) Summary and device instruction manual. A technical comparison to the predicates is provided below:
5
| Comparison Elements | Subject Device | Primary Predicate Device
K171803 | Predicate Device
K133929 | Predicate Device
K143207 | Reference Device
K143430 | SE | | |
|-----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|--------------|--|
| Trade Name/Model | EMS Belt/MC0485 | HIVOX OTC Electrical
Stimulator/SEM44 | Health Expert Electronic
Stimulator/AST-300C and
AST-300D | Revitive IX (OTC)/RIX | SmartTENS | / | | |
| 510(k) Number | To be assigned | K171803 | K133929 | K143207 | K143430 | / | | |
| Regulation Number | 21CFR 890.5850 | 21CFR 882.5890 | 21CFR 882.5890 | 21CFR 882.5890 | 21CFR 882.5890 | SE | | |
| Device Class | II | II | II | II | II | SE | | |
| Product Code | NGX | NUH, NGX | NUH, NGX | NUH, NGX | NUH | SE
NOTE 1 | | |
| Indication
for
Use/Intended Use | To be used to
stimulate healthy
muscles in order to
improve and facilitate
muscle performance. | SEM44 (EMS): The device
is designed to be used for
stimulate healthy muscles in
order to improve and
facilitate muscle
performance.
SEM44 (TENS): The device
is designed to be used for
temporary relief of pain
associated with sore and
aching muscles in the
shoulder, waist, back, neck,
upper extremities (arm),
lower extremities (leg),
abdomen and bottom due to
strain from exercise or
normal household work
activities. | PMS (Mode 18): It is
intended to stimulate healthy
muscles in order to improve
and facilitate muscle
performance.
TENS (Mode 925): To be
used for temporary relief of
pain associated with sore and
aching muscles in the
shoulder, waist, back, back
of the neck, arm, leg, and
foot due to strain from
exercise or normal
household work activities by
applying current to stimulate
nerve. | To temporarily increase
local blood circulation in
healthy leg muscles
To stimulate healthy
muscles in order to
improve and facilitate
muscle performance.
For temporary relief of
pain associated with sore
and aching muscles in the
shoulder, waist, back,
upper extremities (arms)
and lower extremities
(legs) due to strain from
exercise or normal
household duties | The device is intended
for the relief of pain
associated with sore
or aching muscles of
the low back, arms, or
legs due to stain from
exercise or normal
household and work
activities. | SE
NOTE 1 | | |
| Comparison Elements | Subject Device | Primary Predicate Device
K171803 | Predicate Device
K133929 | Predicate Device
K143207 | Reference Device
K143430 | SE | | |
| Location for Use | OTC | OTC | OTC | OTC | OTC | SE | | |
| Basic Specifications | | | | | | | | |
| Power Supply | 4.5V (3 × 1.5V
Alkaline batteries) | 4.5V (batteries, 3x1.5V
AAA) | Adaptor Input: 100-240Vac,
50-60Hz, 0.1A
Output: 5Vdc, 1A
Unit Input: 5Vdc, 1A | Power adaptor
Input: 100-240V, 50/60Hz,
0.18A
Output: 5.0VDC, 1.0A | 3.7V rechargeable
lithium battery | SE
NOTE 2 | | |
| Method of Line Current Isolation | N/A | N/A | Type BF Applied Part | Not publicly available | Not publicly available | SE | | |
| Patient
Leakage
Current | Normal Condition | N/A | N/A | AC: 54.5µA, DC: 0.5µA | Not publicly available | Not publicly available | SE | |
| | Signal Fault Condition | N/A | N/A | AC: 120.0µA, DC: 0.6μΑ | Not publicly available | Not publicly available | SE | |
| Number of Output
Modes | | 10 | EMS: 35
TENS: 15 | 25 | 1 | 7 | SE
NOTE 2 | |
| | Number of Output
Channels | 1 | 2 | 2 | 2 (1 for foot, 1 for body
pads) | 1 | SE
NOTE 2 | |
| Synchronous or
Alternating? | | Alternating | Synchronous | Synchronous | Not publicly available | Not publicly available | SE | |
| Method of Channel
Isolation | N/A | By electrical circuit and
software | Voltage Transform Isolation
"BODY▼" and "BODY▼ "
buttons for body channel,
"SOLE ▲ " and "SOLE ▼ " | Not publicly available | Not publicly available | SE | | |
| Comparison Elements | | Subject Device | Primary Predicate Device
K171803 | Predicate Device
K133929 | Predicate Device
K143207 | Reference Device
K143430 | SE | |
| | | | | buttons for feet channel | | | | |
| Software
/Microprocessor
Control? | /Firmware | Yes | Yes | Yes | Yes | Yes | SE | |
| Automatic
Trip? | Overload | No | Yes | No | Yes | Yes | SE | |
| Automatic
Trip? | No-Load | No | Yes | No | Not publicly available | Yes | SE | |
| Automatic Shut OFF? | | Yes | Yes | Yes | Yes | Yes | SE | |
| Patient
Control? | Override | Yes | Yes | Yes | Yes | Yes | SE | |
| | On/Off
Status? | Yes | Yes | Yes | Not publicly available | Yes | SE | |
| Indicator
Display | Low
Battery? | Yes | Yes | No | Not publicly available | Yes | SE | |
| | Voltage/C
urrent
Level? | Yes | Yes | Yes | Not publicly available | Yes | SE | |
| Timer Range | | 5min, 10min, 15min,
20min, 25min, 30min | 5100minutes | 25minutes | 160minutes | 20min, 25min, 30min,
40min depending on
preset program | SE
NOTE 2 | |
| Compliance
with
Voluntary Standards? | | IEC60601-1-2
IEC60601-1 | IEC60601-1-2
IEC60601-1 | IEC60601-1-2
IEC60601-1 | IEC60601-1-2
IEC60601-1 | IEC60601-1-2
IEC60601-1 | ടല | |
| Comparison Elements | Subject Device | Primary Predicate Device
K171803 | Predicate Device
K133929 | Predicate Device
K143207 | Reference Device
K143430 | SE | | |
| | IEC60601-11
IEC60601-2-10
ISO10993-5/10 | IEC60601-2-10
ISO10993-5/10 | IEC60601-2-10
ISO10993-5/10 | IEC60601-2-10
ISO10993-5/10 | IEC60601-2-10
ISO10993-5/10 | | | |
| Compliance
with
21CFR898 | Yes | Yes | Yes | Yes | Yes | SE | | |
| Weight | 310
(without
g
batteries) | (including
belt
89g
clip,
without batteries)
123g (including
belt clip,
and batteries) | 2kg (without accessories) | 1725g (Without PSU) | 64g | SE
NOTE 3 | | |
| Dimensions | 78 x 140 x 30mm
(controller)
430 x 150 x 12mm
(belt) | 132
ર્ભ્ડ
X
X
29.5mm(including belt clip) | 428 x 428.8 x 185mm | φ360 x 75mm | 155.4x 64.4x 19.1mm | SE
NOTE 3 | | |
| Housing Materials and
Construction | Controller body: ABS
plastic
Belt: Mutispandex
Electrode pads: TPE | ABS plastic | ABS plastic | ABS.
Casing/body
footpads NBR | ABS & TPE | SE
NOTE 4 | | |
| Biocompatibility | All
user
directly
contacting
materials
are compliance with
ISO10993-5
and
ISO10993-10. | All user directly contacting
materials are compliance
with
ISO10993-5
and
ISO10993-10. | All user directly contacting
materials
are compliance
with
ISO10993-5
and
ISO10993-10. | All user directly contacting
materials are compliance
ISO10993-5
and
with
ISO10993-10. | directly
All
user
contacting
materials
are compliance with
ISO10993-5
and
ISO10993-10. | SE | | |
| Output Specifications | | | | | | | | |
| Waveform | Symmetrical
rectangular | Biphasic, square | Pulsed
symmetrical,
biphasic, rectangular, with
interphase interval | Pulsed
symmetrical,
rectangular | Biphasic rectangular
Monophasic
rectangular | SE
NOTE 5 | | |
| @500Ω
Maximum | 35 ±10% | 100±10% (50±10%(Vp)) | 44 ±10% | Foot: 20 | 68 | SE | | |
| Comparison Elements | | Subject Device | Primary Predicate Device
K171803 | Predicate Device
K133929 | Predicate Device
K143207 | Reference Device
K143430 | SE | |
| Output
Voltage
(Volts,
Vp) | | | | | Body: 32 | | NOTE 5 | |
| | (@2kΩ | 76V±10% | 180±10% (90±10%(Vp)) | 80V ±10% | Foot: 95
Body: 118 | 102 | | |
| | a,10kΩ | 145V ±10% | 250±10% (125±10%(Vp)) | 112V ±10% | Foot: 138
Body: 169 | 110 | | |
| Maximum
Output
Current
(mA) | a,500Ω | 70±10% | 200±10% (100±10%(Ip)) | 88 ±10% | Foot: 40
Body: 64 | 133 | | |
| | (@2kΩ | 37.5±10% | 90±10% (45±10%(Ip)) | 40±10% | Foot: 48
Body: 59 | 21 | SE
NOTE 5 | |
| | a,10kΩ | 14.5±10% | 25 ±10% (12.5 ±10% (Ip)) | 11.2±10% | Foot: 14
Body: 17 | 11 | | |
| Pulse Width | | 270us | 50-450ps | 120µs | Foot: 4-7.5us
Body: 1.4-33.6us | 50-250ps | SE
NOTE 5 | |
| Frequency (Hz) | | 1-22Hz | 1-150Hz | 77.3Hz | Foot: 20-53Hz
Body: 35-46Hz | 1-150Hz | SE
NOTE 5 | |
| For Interferential modes
only:
Beat
intended to stimulate healthy
muscles in order to improve
and facilitate muscle
performance.
TENS (Mode 9
Frequency(Hz) | | N/A | N/A | Not publicly available | Not publicly available | Not publicly available | ਫ਼ਜ਼ | |
| For
Multiphase
waveforms
only | Symmetri
cal
Phases? | Yes | N/A | Not publicly available | Not publicly available | Not publicly available | SE | |
| | Phase | N/A | N/A | Not publicly available | Not publicly available | Not publicly available | SE | |
| Comparison Elements | Subject Device | Primary Predicate Device
K171803 | Predicate Device
K133929 | Predicate Device
K143207 | Reference Device
K143430 | SE | | |
| | Duration | | | | | | | |
| Maximum Phase
Charge (µC) @500Ω | 23.52 | 0.045 | 12.78 | Foot: 41
Body: 15 | 20.01 | SE
NOTE 5 | | |
| Maximum Current
Density
@500Ω | 0.13 | 0.667 | 0.235 | Foot: 0.023
Body: 0.082 | 0.066 | SE
NOTE 5 | | |
| Maximum Power
Density
@500Ω | 0.0004 | 0.0046 (average) | 1.38 | Foot: 0.55
Body: 1.64 | 2.66 (average) | SE
NOTE 5 | | |
| Burst
Mode | Pulses per
burst | 1 | 3 | Not publicly available | Foot: 11-256
Body: 49-154 | Not publicly available | SE | |
| | Bursts per
second | 1/22Hz | 2/60Hz | Not publicly available | Foot: 0.1-0.5
Body: 0.2-0.5 | Not publicly available | SE | |
| | Burst
duration
(seconds) | 0.27ms | 36ms | Not publicly available | Foot: 1.9-8.4s
Body: 1.9-6.5s | Not publicly available | SE | |
| | Duty
Cycle
[Line(b) x
Line (c)] | N/A | 36ms/390ms | Not publicly available | Foot: 0.56-0.87
Body: 0.66-0.87 | Not publicly available | SE | |
| ON Time (seconds) | 1s | 2s | 0.6s | Foot: 1.92-8.34s
Body: 1.92-6.52s | Not publicly available | SE | | |
| OFF Time (seconds) | 3s | 2s | 0.6s | Foot: 1-1.5s
Body: 1s | Not publicly available | SE | | |
6
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8
9
10
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Comparison in details:
NOTE 1: The "Intended Use" of the subject device is the same as the predicate device K171803 SEM44's EMS mode and K133929's PMS (mode 1~8), as well as is within the predicate device K143207. Meanwhile, the "Product Code" of the subject device is within the predicate devices, and these kinds of powered muscle stimulator are classified as NGX in accordance with FDA regulation. This define does not affect the intended use or normal use of the subject device.
NOTE 2: Although the "Power Supply", "Number of Output Modes", "Number of Output Channels", and "Timer Range" of the subject device are a little different from the predicate devices, these differences do not raise new questions of safety and effectiveness.
NOTE 3: Although the "Weight" and "Dimensions" of the subject device are different from the predicate devices, these differences are insignificant in the terms of safety or effectiveness.
NOTE 4: The "Housing Materials and Construction" (materials of skin-contacting components) of the enclosure of the subject device is consistent completely with the predicate devices, and the material of the electrodes is TPE (Thermo-Plastic Elastomers), which is consistent with the electrodes used by K143430. Although their supplier is not sure, they all comply with the requirements of ISO 10993-1 and have been tested and passed the cytotoxicity test, skin sensitization test, and irritation test. So these differences will not raise any safety or effectiveness issue.
NOTE 5: Although the "Maximum Output Voltage", "Maximum Output Current", "Pulse Duration", "Frequency", "Maximum Phase Charge", "Maximum Current Density", and "Maximum Power Density" of the subject device are a little different from the predicate devices, they all comply with the requirements of IEC 60601-1 and IEC 60601-2-10 standard, as well as the Guidance for Powered Muscle Stimulator for Muscle Conditioning. So these differences will not raise any safety or effectiveness issue.
CONCLUSION: The subject device is substantially equivalent to the predicate devices.
VII.Performance Data
The following performance data were provided in support of the substantial equivalence determination.
1) Biocompatibility Testing
The biocompatibility evaluation for the body-contacting components of the EMS Belt was conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices –Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on June 16, 2016", as recognized by FDA. The battery of testing was performed to, and passed, including:
-
ISO 10993-5:2009/(R)2014, Biological Evaluation of Medical Devices –Par t 5: Tests for In Vitro Cytotoxicity
12
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ISO 10993-10:2010. Biological Evaluation of Medical Devices -Par t 10: Tests for Irritation and Skin Sensitization
2) EMC and Electrical Safety
EMC and Electrical safety testing was performed to, and passed, the following standards:
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IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
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IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
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IEC 60601-1-11 Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
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IEC 60601-2-10 Medical electrical equipment Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
3) Software Verification and Validation
Software documentation consistent with moderate level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
4) Other Performance Verification
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The Electrode Pad Performance Test Report has been conducted to verify the current dispersion and shelf-life of the electrodes used by the subject device in the expiration date according to the requirements of the FDA Guidance -Shelf Life of Medical Device and ASTM F1980-07 Standard.
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The waveform and output test report has also been conducted to verify the output specifications of the subject device according to the FDA Guidance for Powered Muscle Stimulator 510(k)s.
Summary
Based on the above performance as documented in this application. EMS Belt was found to have a safety and effectiveness profile that is similar to the predicate device.
VIII. Conclusions
The subject device EMS Belt is to be concluded substantial equivalent to its predicate devices.