(123 days)
No
The device description focuses on Microcurrent technology (EMS) and user-controlled parameters, with no mention of AI or ML.
No.
The device is intended to stimulate healthy muscles to improve or facilitate muscle performance, rather than to treat a medical condition.
No
The device is intended to stimulate muscles to improve performance, not to diagnose medical conditions.
No
The device description explicitly states it consists of a control unit, large belt, small belt, and electrode pads, which are all hardware components. It also mentions being battery operated and having physical buttons for control.
Based on the provided information, the Gymform® TOTAL ABS (Model: WB-245) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "stimulate healthy muscles in order to improve or facilitate muscle performance." This is a physical function, not a diagnostic test performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The device uses electrical stimulation (EMS) applied to the skin to target muscles. This is a physical intervention, not a method for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to collecting, analyzing, or interpreting biological samples for diagnostic purposes.
In summary, the Gymform® TOTAL ABS is a muscle stimulator intended for fitness and muscle performance enhancement, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Gymform® TOTAL ABS (Model: WB-245) is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.
The large belt is intended for use on the muscles in abdomen. The small belt for working the leg and arm muscles, intended for use on the muscles in arms, legs (lower extremities) and thighs areas separately.
Product codes
NGX
Device Description
The Gymform® TOTAL ABS( Model: WB-245) consists of a control unit, large belt, small belt and electrode pads. The control unit enclosed in ABS plastic case. The device is design based on Microcurrent technology (Electro Muscle Stimulation-EMS) which uses a gentle current to condition, tone and strengthen muscles.
The Gymform® TOTAL ABS( Model: WB-245) is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The TOTAL ABS may be considered a technique or method for muscle training. It is a battery operated muscle stimulation system specifically designed to training muscles.
The large belt is intended for use on the muscles in abdomen. The small belt for working the leg and arm muscles, intended for use on the muscles in arms, legs (lower extremities) and thighs areas separately.
The stimulator sends gentle electrical current to targeted muscle group through the electrodes placed on the skin. The parameters of the unit are controlled by the buttons. Its intensity level can be adjustable by user.
There are 6 modes for output stimulation, and for each mode, there are 10 levels of output intensity can be choose. Default time is 10minutes for output stimulation.
Power is derived from 3 pieces of AAA batteries located in a compartment protected by a removable battery cover for the Fitness Belt.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdomen, arms, legs (lower extremities), thighs
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)
Performance data Summary:
The Device has been evaluated the safety and performance by lab bench testing according to the following standards:
Electrical safety and electromagnetic compatibility (EMC)
-
IEC 60601-1-2: 2014: Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance. Collateral Standard: Electromagnetic Compatibility
-
IEC 60601-1:2005: Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
-
IEC 60601-1-11:2015: Medical Electrical Equipment - Part 1-11: 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: 2012: Medical Electrical Equipment - Part 2: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators.
Biocompatibility testing:
The biocompatibility evaluation for the 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. The battery of testing included the following tests:
-
Biological evaluation of medical device Part 10: Tests for Intracutaneos Reactivity test and skin sensitization (ISO 10993-10:2010)
- Cytotoxicity test: Cytotoxicity Test with MTT Method according to ISO 10993-5. Conclusion: Non cytotoxic.
- Skin sensitization: Skin Sensitization with test method: 0.9% Sodium Chloride Injection Extract and Sesame Oil Extract according to ISO 10993-10. Conclusion: No skin sensitization.
- Intracutaneous Reactivity test: Skin Intracutaneous Reactivity with test method: 0.9% Sodium Chloride Injection Extract and Sesame Oil Extract according to ISO 10993-10. Conclusion: No skin irritation.
-
Biological evaluation of medical device Part 5: Cytotoxicity test- In vitro method (ISO 10993-5:2009)
Software Verification and Validation Testing:
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern, since a failure of the Software Device result in Minor Injury, either to a patient or to a user of the device.
Performance verification testing:
The waveform test report has also been provided to verify the parameters of the below output current pulse waveform parameter was verified: Output voltage, output current, Output waveform frequency, pulse width, maximum current and power density and so on were tested to demonstrate substantial equivalence to predicate devices.
Usability study testing:
Usability testing (OTC Study) was completed in 24 subjects to evaluate device human factors and label comprehension.
These usability study tests demonstrate that the device and its labeling can meet with the requirement:
- the lay user can self-select themselves as being appropriate users of this device by the external box labeling,
- the lay user can apply the treatment safely and correctly according to the instructions for use, and
- the lay user can understand all indications, contraindications, warnings and be able to identify whether they are within any contraindicated group; and be able to understand the user manual.
Clinical test: No clinical testing is need.
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).
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.
January 15, 2021
Well Brain International Ltd. Jet Li Regulation Manager Guangzhou Kinda Biological Technology Co., Ltd 6F, No.1 TianTai road, Science City, LuoGang District, GuangZhou, Guangdong China
Re: K202653
Trade/Device Name: Gymform Total ABS Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: December 14, 2020 Received: December 18, 2020
Dear Jet Li:
We have reviewed vour 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/cfpmp/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.
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
1
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 mediation-emitting products, including information about labeling regulations, please see Device (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,
Heather Dean, Ph.D. Assistant Director. Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202653
Device Name
Gymform® TOTAL ABS, Model: WB-245
Indications for Use (Describe)
The Gymform® TOTAL ABS (Model: WB-245) is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.
The large belt is intended for use on the muscles in abdomen. The small belt for working the leg and arm muscles, intended for use on the muscles in arms, legs (lower extremities) and thighs areas separately.
Type of Use (Select one or both, as applicable)
| ☑ New Construction (Lot/SFR, 201+ Lots) |
|---|
| ----------------------------------------- |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary K202653
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR807.92.
1. Submitter's Information
- 510(k) Sponsor: Well Brain International Ltd. �
- Address: Room 1403 Fook Yip Building, 53-57 Kwai Fung Crescent, Kwai Chung, Hong Kong, China �
- Phone: (852) 2619-0833 �
- Fax: (852) 2429-0960 �
- � Contact Person: Victor K Wai
- � Email: victor@wellbrain-intl.com
Subject Device Information 2.
| • | Trade Name: | Gymform® TOTAL ABS, Model: WB-245 |
|---|---|---|
| • | Common Name: | Powered muscle stimulator |
| • | Classification name: | Stimulator, Muscle, Powered, For muscle conditioning |
| • | Review Panel: | Physical Medicine |
| • | Product Code: | NGX |
| • | Regulation Class: | 2 |
| • | Regulation Number: | 890.5850 |
3. Application Correspondent
Application Correspondent: Guangzhou KINDA Biology Technology Co.,Ltd.
- Address: 6F, No.1 TianTai road, Science City, LuoGang District, GuangZhouCity,China �
- Contact Person: Mr. Jet Li �
- � Tile: Regulation Manager
- � Tel: +86-18588874857
- � Email:med-jl@foxmail.com
4
Predicate and Reference Device Information 4.
| 510k
Number | K130074
(Primary
predicate) | K102295
(Reference
device I) | K092476
(Reference
device II) | K183674
(Reference
device III) |
|----------------------|------------------------------------|------------------------------------------|-------------------------------------|-------------------------------------------------------------|
| Sponsor | Well Brain
International
Ltd | Leto
Enterprises
Incorporation | SPORT-
ELEC
S.A. | Shenzhen
Leading
Perfection
Technology
Co., Ltd |
| Device
Name | ABS - A-
Round | X2ABS
Dual
Channel
Fitness Belt | Body
Control
System '4M' | Electronic
Pulse
Stimulator,
Model S3 |
| Product
Code | NGX | NGX | NGX | NGX |
| Regulation
Number | 890.5850 | 890.5850 | 890.5850 | 890.5850 |
| Regulation
Class | 2 | 2 | 2 | 2 |
5. Device Description
The Gymform® TOTAL ABS( Model: WB-245) consists of a control unit, large belt, small belt and electrode pads. The control unit enclosed in ABS plastic case. The device is design based on Microcurrent technology (Electro Muscle Stimulation-EMS) which uses a gentle current to condition, tone and strengthen muscles.
The Gymform® TOTAL ABS( Model: WB-245) is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The TOTAL ABS may be considered a technique or method for muscle training. It is a battery operated muscle stimulation system specifically designed to training muscles.
The large belt is intended for use on the muscles in abdomen. The small belt for working the leg and arm muscles, intended for use on the muscles in arms, legs (lower extremities) and thighs areas separately.
The stimulator sends gentle electrical current to targeted muscle group through the electrodes placed on the skin. The parameters of the unit are controlled by the buttons. Its intensity level can be adjustable by user.
There are 6 modes for output stimulation, and for each mode, there are 10 levels of output intensity can be choose. Default time is 10minutes for output stimulation.
5
Power is derived from 3 pieces of AAA batteries located in a compartment protected by a removable battery cover for the Fitness Belt.
6. Intended Use / Indications for Use
The Gymform® TOTAL ABS( Model: WB-245) is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.
The large belt is intended for use on the muscles in abdomen. The small belt for working the leg and arm muscles, intended for use on the muscles in arms, legs (lower extremities) and thighs areas separately.
7. Performance data Summary
The Device has been evaluated the safety and performance by lab bench testing according to the following standards:
Electrical safety and electromagnetic compatibility (EMC)
-
IEC 60601-1-2: 2014: Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance. Collateral Standard: Electromagnetic Compatibility
-
IEC 60601-1:2005: Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
-
IEC 60601-1-11:2015: Medical Electrical Equipment - Part 1-11: 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: 2012: Medical Electrical Equipment - Part 2: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators.
Biocompatibility testing
The biocompatibility evaluation for the 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
6
Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process, "as recognized by FDA. The battery of testing included the following tests:
- Biological evaluation of medical device Part 10: Tests for Intracutaneos Reactivity test and skin sensitization (ISO 10993-10:2010)
| Test | Test summary | Conclusion |
|---|---|---|
| Cytotoxicity test | Cytotoxicity Test with MTT Method | |
| according to ISO 10993-5 | Non cytotoxic | |
| Skin sensitization | Skin Sensitization with test method: | |
| 0.9% Sodium Chloride Injection | ||
| Extract and Sesame Oil Extract | ||
| according to ISO 10993-10 | No skin sensitization | |
| Intracutaneous Reactivity test | Skin Intracutaneous Reactivity with | |
| test method: 0.9% Sodium Chloride | ||
| Injection Extract and Sesame Oil | ||
| Extract according to ISO 10993-10 | No skin irritation |
- Biological evaluation of medical device Part 5: Cytotoxicity test- In vitro method (ISO 10993-5:2009)
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern, since a failure of the Software Device result in Minor Injury, either to a patient or to a user of the device.
Performance verification testing:
The waveform test report has also been provided to verify the parameters of the below output current pulse waveform parameter was verified:
Output voltage, output current, Output waveform frequency, pulse width, maximum current and power density and so on were tested to demonstrate substantial equivalence to predicate devices.
Usability study testing:
7
Usability testing (OTC Study) was completed in 24 subjects to evaluate device human factors and label comprehension.
These usability study tests demonstrate that the device and its labeling can meet with the requirement:
- the lay user can self-select themselves as being appropriate users of this device by the external box labeling, 2) the lay user can apply the treatment safely and correctly according to the instructions for use, and 3) the lay user can understand all indications, contraindications, warnings and be able to identify whether they are within any contraindicated group; and be able to understand the user manual.
8. Clinical test
No clinical testing is need
9. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, mode of operation, and intended use of Gymform® TOTAL ABS( Model: WB-245) is substantially equivalent to the predicate devices quoted above.
Microcurrent technology (Electro Muscle Stimulation-EMS) is the technological principle for both the subject and predicate devices. . The device is design based on Microcurrent (Electro Muscle Stimulation-EMS) which uses a gentle current to condition, tone and strengthen muscles.
The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| Elements of
Comparison | Subject Device | Primary
predicate | Reference
device I | Reference
device II | Reference device III | Remark |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Sponsor | Well Brain
International Ltd | Well Brain
International Ltd | Leto
Enterprises
Incorporation | SPORT-ELEC
S.A. | Shenzhen Leading
Perfection Technology
Co., Ltd | -- |
| Device Name
and Model | Gymform®
TOTAL ABS,
(Model: WB-245) | ABS -A- Round | X2ABS Dual
Channel
Fitness Belt | Body Control
System '4M' | Electronic Pulse
Stimulator, Model S3 | -- |
| 510 (K)
Number | Applying | K130074 | K102295 | K092476 | K183674 | -- |
| Indications
for Use | The Gymform®
TOTAL ABS(
Model: WB-245) | The
GYMFORM6
ABS-A-ROUND
is intended to | The X2ABS
Dual Channel
Fitness Belt is
intended for | The Body
Control -4M' is
intended for use
by healthy | Mode 1 (PMS):
To be used for
stimulating healthy | Minor
difference |
| | is intended to | stimulate | use by healthy | persons to apply | muscles in order to | Note 1 |
| | stimulate healthy
muscles in order
to improve or
facilitate muscle
performance.. | healthy
muscles in
order to
improve or
facilitate
muscle
performance.
The ABS-A-
ROUND may
be considered a
technique or
method for | persons to
apply trans-
coetaneous
electrical
muscle
stimulation
(EMS) through
skin contact
electrodes for
the follow ing
purposes: | trans-
coetaneous
electrical muscle
stimulation
(EMS) through
skin contact
electrodes for
the follow ing
purposes.
Improvement of
muscle tone and
firmness, for | improve and
facilitate muscle
performance.
Mode 2 (TENS):
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 | For
predicat
e device
IV, only
compare
d with its
indicatio
n for use
in EMS
mode. |
| | small belt for
working the leg
and arm
muscles,
intended for use
on the muscles
in arms, legs
(low er
extremities) and
thighs areas
separately. | muscle training.
The 3-area belt
is intended for
use on the
muscles in
abdomen, left
waist and right
w aist
alternately.
The Mini belt
accessory is
intended for
use on the
muscles in
arms, legs
(low er
extremities),
thighs and
buttocks areas
separately.. | of muscle tone
of the muscles
in the
abdomen. | strengthening
muscles in arms,
abdomen, thighs
and buttocks
areas. | | |
| Channel | 1 | 3 | 2 | 2 | 1 | SE |
| Synchronous
/Alternating
channels | Synchronous | -- | Synchronous | -- | Symmetrical
rectangular | SE |
| Stimulated
muscles | Abdomen, arms,
legs and thighs | Arms, Waist,
abdomen,
legs, thighs
and buttocks
areas | Abdomen | Arms, abdomen,
thighs and
buttocks areas | Arm, leg, abdomen,
hip, feet | SE |
| Number of
programs | 6 | 6 | 8 | 4 | 1 | SE |
| Number of
output
intensity level | 10 steps | 99 steps | 28 steps | -- | -- | Minor
differenc
e
Note 2 |
| Maximum
output
voltage | 81.6V @ 500Ω
96V @ 2kΩ
99.2V @ 10kΩ | 108V @ 500 Ω
124V @ 2k Ω
126V @ 10k Ω | from 0 to 60V-
from 0 to
1000 Ohm) | from 0 to 60V-
from 0 to 1000
Ohm) | 40±20% V @ 500 Ω
64±20%V @ 2k Ω
76±20% V @ 10k Ω | Minor
differenc
e
Note 3 |
| Maximum
Output
Current | 163mA @ 500Ω
48mA @ 2kΩ
9.92mA @ 10kΩ | 216mA@ 500
Ω
62mA@ 2k Ω
12.6mA@ 10k
Ω | From 0 to 60
mA (From 0 to
1000 Ohm) | From 0 to 70mA | 80±20%
mA@500ohm;
32±20% @2kohm;
7.6±20% mA
@10kohm | Minor
differenc
e
Note 3 |
| Frequency
range(Hz) | 50,60,70 Hz | 2 Hz, 10 Hz,
50 Hz, 90 Hz,
120 Hz | 8.5 to 64 Hz | 50 to 70 Hz | Mode 1: 4-35Hz | Minor
differenc
e
Note 3 |
| Pulse w idth
range(us) | 200 | 100 us / 120 us | 220 | 200 | 200 | Minor
differenc
e
Note 3 |
| Contraction
and
Relaxation
time | Adjustable, due
to different
modes. | Adjustable, due
to different
modes. | Adjustable,
due to
different
modes. | Adjustable, due
to different
modes. | -- | SE |
| Pow er | 3 x 1.5V AAA
batteries | 3 x 1.5V AAA
batteries | 2 x 1.5V AAA
batteries | 3 x 1.5V AAA
batteries | USB rechargeable
battery, 3.7V | SE |
| Electrode
Size (cm²) | 34.5 x 2 pieces;
total 5 pairs of
electrode pad | 128 | 32 | 128 | -- | Minor
differenc
e
Note 4 |
| Maximum
Current
Density(mA/c
m² @ 500Ω) | 0.041 (mA/cm²
@ 500Ω) | 0.057 mA/cm² @
500 Ω | 0.032
(for the
smallest size
electrode 32.0
cm²) | -- | Hips pad: 0.079
mA/cm²
Arms and legs pad:
0.104 mA/cm²
Abdomen pad: 0.111 | Minor
difference
e
Note 5 |
| Maximum
power
Density | 28.81μW/cm² | 53.8 μW/cm² @
500 Ω | 16. 38 μW/cm² | -- | Hips pad:
100μW/cm²;
Arms and legs pad:
200μW/cm²;
Abdomen pad:
200μW/cm²;
Feet pad:30μW/cm² | Minor
difference
e
Note 5 |
| | | | | | Feet pad: 0.016 mA/cm² | |
| | | | | | | |
| Timer Range | Default time is
10minutes. | Default time is
19 minutes | Default time is
10 minutes,
minimum time
is 5 minutes | Default time is 4
minutes 30 sec | 25 min | Minor
difference
e
Note 6 |
| LED display | Indicate the
following
information:
On/off
status, Mode
selection. | -- | Indicate the
following
information:
Sound on/off,
Keylock, Low
battery,
Channel
indication,
Intensity level,
Mode
selection. | -- | On/off status, Low
battery | SE |
| Environment
for operating | Temperature: 0
~ 35° C
Humidity: