Electrical Stimulator System

• K Number: K232439
• Device Name: Electrical Stimulator System
• Manufacturer: Gymmax Technology Shenzen Co., Ltd.
• Date Cleared: 2024-03-21 ( 220 days)
• Product Code: NUH NGX
• Regulation Number: 882.5890

Intended Use

TENS (TENS 1 and TENS 2) To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities. PMS (STIM1 STIM2 STIM3 and STIM4) To stimulate healthy muscles in order to improve and facilitate muscle performance.

Device Description

The Electrical Stimulator System delivers electric pulses to the user's body areas in shoulder, waist, back, arm, and leg. The portable and compact device has multiple modes frequencies, including transcutaneous electrical nerve stimulation (TENS) and power muscle stimulation (PMS) that is also called Electical Muscle Stimulation (EMS). It includes the operating elements of an M button, intensity increase button, intensity decrease button, and can be attached and detached to electrodes.

Predicate Devices

K171803, K133929, K130802

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or any related concepts like training sets, test sets, or specific performance metrics typically associated with AI/ML algorithms. The device description focuses on basic electrical stimulation modes and controls.

Therapeutic

Yes

The device is intended for the temporary relief of pain and to stimulate muscles, which are therapeutic applications.

Diagnostic

No

The device is described for pain relief and muscle stimulation, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly mentions hardware components like buttons, electrodes, and the delivery of electric pulses, and the performance studies include electrical safety and biocompatibility testing, indicating it is a physical device with electrical components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is for temporary relief of pain and muscle stimulation. This involves applying electrical pulses to the body, not analyzing samples taken from the body (like blood, urine, or tissue).
• Device Description: The description details an electrical stimulator that delivers pulses to the user's body. It doesn't mention any components for sample collection or analysis.
• Lack of IVD Indicators: There are no mentions of analyzing biological samples, diagnostic purposes, or any of the typical characteristics of an IVD device.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device's function is entirely external and therapeutic/rehabilitative.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

TENS (TENS 1 and TENS 2)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.

PMS (STIM1 STIM2 STIM3 and STIM4)
To stimulate healthy muscles in order to improve and facilitate muscle performance.

Product codes

NUH, NGX

Device Description

The Electrical Stimulator System delivers electric pulses to the user's body areas in shoulder, waist, back, arm, and leg. The portable and compact device has multiple modes frequencies, including transcutaneous electrical nerve stimulation (TENS) and power muscle stimulation (PMS) that is also called Electical Muscle Stimulation (EMS). It includes the operating elements of an M button, intensity increase button, intensity decrease button, and can be attached and detached to electrodes.

The electrodes cleared include accessory electrodes, which may be packaged separately and/or together with the subject device.

The associated accessories include:

Belt * 1
Control Unit * 1
USB Charging Cable * 1
Belt Extension Kit * 1
Storage pouch * 1

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

shoulder, waist, back, arm, and leg

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)

Non-clinical tests were performed.

• Biocompatibility
• Software Validation
• Electromagnetic compatibility and electrical safety
• Function test (Including output waveform, stimulation parameters and current distribution on the electrodes)

All the test results demonstrate Election meets the requirements of its pre-defined acceptance criteria and intended uses, and is substantially equivalent to the predicate devices.

No clinical test data was used to support the decision of substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K171803, K133929, K130802

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 21, 2024

Electronic Pulse Stimulator % Salon Chen System Engineer IMD Medical & Drug Technology Services Institutions Room 308, Building 11, No. 23 Jinqu Road Wanjiang District, Dongguan City ShenZhen City, Guangdong Province 518117 China

Re: K232439

Trade/Device Name: Electrical Stimulator System Regulation Number: 21 CFR 882.5890; 21 CFR 890.5850 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: February 20, 2024 Received: February 20, 2024

Dear Salon Chen:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 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 ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

Robert Kang -S

for Pamela Scott

Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K232439

Device Name Electrical Stimulator System

Indications for Use (Describe)

TENS (TENS 1 and TENS 2)

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.

PMS (STIM1 STIM2 STIM3 and STIM4)

To stimulate healthy muscles in order to improve and facilitate muscle performance.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 34 CFR 301 Subpart D)	Over-The-Counter Use (34 CFR 301 Subpart C)
-----------------------------------------------------------------------	---------------------------------------------------------------------------------

__ Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary- K232439

1. Submitter's Identification:

• Company Name: Gymmax Technology Shenzhen Co., Ltd. >
• ハ Establishment Registration Number: 3007689716
• ▲ Address:5F 4th Bldg., Heping Complex (4th Bldg. Huimingsheng Technology Park) Fuhai Subdistrict, Baoan District Shenzhen City, Guangdong Province 518103 P.R.C.
• A Phone: [phone]
• ♪ Fax: [phone]
• Contact Person (Title): Benson Wang (General Manager) A
• E-mail: [e-mail] ハ

• Date of Preparation: Feb.19, 2024

2. Name of the Device:

• Electrical Stimulator System A
• Models: GMX-007 and GMX-006 A
• 3. Common Name and Classification:
• Stimulator, Nerve, Transcutaneous, Over-The-Counter A

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• ♪ Classification Product Code: NUH, NGX

• Regulation Number:21 CFR 882.5890

• Class: Il

4. Predicate Device Information1:

• ハ 510(k) Number: K171803

• Predicate Device Name: HIVOX OTC Electrical Stimulators Model SEM44 and Model SEM44-1

• Manufacturer: HivoxBiotek Inc. A
• This predicate has not been subject to a design-related recall A
• A No reference devices were used in this submission.
• 5. Predicate Device Information2:
• A 510(k) Number: K133929
• Predicate Device Name: Health Expert Electronic Stimulator, Model AST300Cand AST-300D A
• Manufacturer: Shenzhen OSTO Technology Company Limited A
• This predicate has not been subject to a design-related recall A
• A No reference devices were used in this submission.
• 6. Predicate Device Information3:

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• 510(k) Number: K130802 A
• Predicate Device Name: OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060) >

• Manufacturer: SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD

• This predicate has not been subject to a design-related recall A
• No reference devices were used in this submission. A
• 7. Application Correspondent
• A Company Name: IMD Medical & Drug technology service institutions
• Phone: [phone] A
• A Fax: [phone]
• Contact Person (Title): Salon Chen (System engineer) A
• A E-mail: [e-mail]
• Address: Room 308, Building 11, No. 23 Jinqu Road, Wanjiang District, Dongguan City, Guangdong Province, China A

8. Device Description

The Electrical Stimulator System delivers electric pulses to the user's body areas in shoulder, waist, back, arm, and leg. The portable and compact device has multiple modes frequencies, including transcutaneous electrical nerve stimulation (TENS) and power muscle stimulation (PMS) that is also called Electical Muscle Stimulation (EMS). It includes the operating elements of an M button, intensity increase

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button, intensity decrease button, and can be attached and detached to electrodes.

The electrodes cleared include accessory electrodes, which may be packaged separately and/or together with the subject device.

The associated accessories include:

Belt * 1

Control Unit * 1

USB Charging Cable * 1

Belt Extension Kit * 1

Storage pouch * 1

9. Indications for Use

TENS (TENS 1 and TENS 2)

To be used for temporary relief of pain associated with shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.

PMS (STIM1、STIM2、STIM3 and STIM4)

To stimulate healthy muscles in order to improve and facilitate muscle performance.

10. Comparison to the predicate device

Electrical stimulation is the technological princes and predicate device. In the EMS modes, electronic pulses are sent through electrode passively exercise the affected muscle receives this signal, it contracts and flexes naturally, as it would during physical

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exercise. And like with physical exercise, when the muscle relates and the cycle can start over again. In the TENS modes, the gentle electrical pulses were sent through electrode pass and into stir to block or shut out the brain from the source of the pain.

Table 1: Technological Characteristics

| Elements of Comparison | Proposed Device | Predicate Device1
(K171803) | Predicate Device2
(K133929) | Predicate Device3
(K130802) | Judgment | | |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|------------------------------|----------|
| Company Name | Gymmax Technology
Shenzhen Co., Ltd. | HIVOX BIOTEK INC. | Shenzhen OSTO
Technology Company
Limited | SHENZHEN DONGDIXIN
TECHNOLOGY CO, LTD | / | | |
| Device Name | Electrical Stimulator
System | HIVOX OTC Electrical
Stimulator/SEM44 | Health Expert Electronic
Stimulator, Model AST300C
and AST-300D | OTC ELECTRICAL STIMULATOR
(MT9001), OTC TENS DEVICE
(LT3060) | / | | |
| Classification Product Code | NUH | NUH | NUH | NUH | SE | | |
| Subsequent Product Codes | NGX | NGX | NGX | NGX | SE | | |
| Regulation | 21 CFR 882.5890 | 21 CFR 882.5890 | 21 CFR 882.5890 | 21 CFR 882.5890 | SE | | |
| Classification Name | Transcutaneous electrical
nerve stimulator for pain
relief | Transcutaneous
electrical nerve
stimulator for pain
relief | Transcutaneous electrical
nerve stimulator for pain
relief | Transcutaneous electrical nerve
stimulator for pain relief | SE | | |
| Class | 2 | 2 | 2 | 2 | SE | | |
| | Prescription or OTC | OTC | OTC | OTC | OTC | SE | |
| | Functions and design | Electrical stimulation | Electrical stimulation | Electrical stimulation | Electrical stimulation | SE | |
| | Power Source(s) | Rechargeable battery | 4.5V (batteries,
3×1.5V AAA) | Adaptor Input: 100- 240Vac,
50-60Hz, 0.1A Output: 5Vdc,
1A Unit Input: 5Vdc, 1A | 9V batteries | SE | |
| | Method of Line Current
Isolation | Type BF Applied Part | N/A | Type BF Applied Part | N/A | SE | |
| Patient
Leakage
Current | Normal condition | N/A | N/A | AC: 54.5μA, DC: 0.5μA | 0.61μA | SE | |
| | Single fault
condition | N/A | N/A | AC:120.0μA,
DC: 0.6μA | 0.68μA | SE | |
| | Number of Output Modes | TENS: 2
EMS: 4 | EMS: 35
TENS:15 | EMS: 8
TENS:17 | TENS: 1
EMS: 1 | SE
Note 3 | |
| | Number of Output Channels | 1 | 2 | 2 | N/A | SE
Note 3 | |
| | Synchronous
or
Alternating | N/A | Synchronous | Synchronous | Alternating | SE | |
| | Method of Channel Isolation | By electrical circuit and
software | By electrical circuit and
software | Voltage Transform Isolation
"BODY▼" and "BODY▼"
buttons for body channel,
"SOLE▲" and "SOLE▼"
buttons for feet channel | By electrical circuit and
software | SE | |
| | Regulated Current or
Regulated Voltage? | Current control | Regulated voltage | Current control | Current control | SE | |
| | Software/Firmware/Micropr
ocessor Control | Yes | Yes | Yes | Yes | SE | |
| | Automatic Overload Trip? | No | Yes | No | Yes | SE | |
| | Automatic No-Load Trip? | Yes | Yes | No | Yes | SE | |
| | Automatic Shut Off? | Yes | Yes | Yes | Yes | SE | |
| | Patient Override Control? | Yes | Yes | Yes | Yes | SE | |
| | On/Off Status? | Yes | Yes | Yes | Yes | SE | |
| Indicato
r Display | Low Battery? | Yes | Yes | Yes | Yes | SE | |
| | Voltage/Current
Level? | Yes | Yes | Yes | Yes | SE | |
| Timer Range (minutes) | 30minutes | 5100minutes | 25 minutes | 1-60 minutes | SE
Note 3 | | |
| Weight | 40.6G [without pad] | 89g (including belt
clip,
without batteries)
123g (including belt
clip,
and batteries) | 2Kg (Without accessories) | 128g (including batteries) | SE
Note 4 | | |
| Dimensions (in.) [W x H x D] | 755513.8 mm | 132 x 63 x
29.5mm (including
belt
clip) | 428mm x 428.8mm x
185mm | 117 x 60 x 34 mm | SE
Note 4 | | |
| Housing Materials and
Construction | ABS+PC | ABS | ABS | ABS | SE | | |
| Intended Use | TENS (TENS 1 and TENS
2)
To be used for temporary
relief of pain associated
with sore and aching
muscles in the shoulder,
waist, back, arm, and leg,
due to strain from exercise
or normal household and
work activities. | 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
| PMS (Mode 18) It is
intended to stimulate healthy
muscles in order to improve
and facilitate muscle
performance. | MT9001 -
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), and lower extremities (leg)
due to strain from exercise or
normal household work activities.
EMS: The device is designed to be
used for stimulate healthy muscles
in order to improve and facilitate
muscle performance. | SE
Note 1 | | |
| Intended Use | PMS (STIM1 、STIM2
STIM3 and STIM4)
To stimulate healthy
muscles in order to improve
and facilitate muscle
performance. | SEM44-1 -
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. | 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. | LT3060 -
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), and lower extremities (leg)
due to strain from exercise or
normal household work activities. | SE
Note 1 | | |
| Safety factor & Performance | Proposed Device | Predicate Device1 | Predicate Device2 | Predicate Device3 | Judgment | | |
| Electrical Safety | Compliance with IEC 60601-1 | Compliance with IEC 60601-1 | Compliance with IEC 60601-1 | Compliance with IEC 60601-1 | SE | | |
| EMC | Compliance with IEC 60601-1-2 | Compliance with IEC 60601-1-2 | Compliance with IEC 60601-1-2 | Compliance with IEC 60601-1-2 | SE | | |
| Biocompatibility | Compliance with ISO 10993-1 | Compliance with ISO 10993-1 | Compliance with ISO 10993-1 | Compliance with ISO 10993-1 | SE | | |
| Performance | Compliance with IEC 60601-2-10:2012 medical electrical equipment - part 2-1 | Compliance with IEC 60601-2-10:2012 medical electrical equipment - part 2-1 | Compliance with IEC 60601-2-10:2012 medical electrical equipment - part 2-1 | Compliance with IEC 60601-2-10:2012 medical electrical equipment - part 2-1 | SE | | |
| Waveform | Biphasic, symmetrical | Biphasic, square | Pulsed, symmetric, Biphasic, Rectangular | Biphasic Square | SE | | |
| Burst Mode | Pulses per burst | 2 | 3 | -- | 7 | N/A | SE |
| | Bursts per second | 5 / 50Hz | 2/60Hz | -- | 0.5/1/2/3/4/5 Hz | N/A | SE |
| Burst Mode | Burst duration (seconds) | 20ms | 36ms | -- | 70ms | N/A | SE |
| | Duty
Cycle
[Line(b) x
Line (c)] | 20ms/100ms | 36ms/390ms | -- | 35ms/350ms | N/A | SE |
| ON Time (seconds) | | 0.25s6.5s | 2s | 0.6s | N/A | 1-30 | SE |
| OFF Time (seconds) | | 0.25s4.6s | 2s | 0.6s | N/A | 1-60 | SE |
| Maximum output
voltage (volts+/-20%)
at 500Ω | | TENS 1:112
TENS 2: 114
STIM1:116
STIM2:116
STIM3:76
STIM4: 70 | 100±10 % (50±10 %(Vp)) | 44±10% | 96±20%
(48±20% (Vp)) | | (Note 1) |
| Maximum output
voltage (volts+/-20%)
at 2KΩ | | TENS 1: 250
TENS 2: 240
STIM1: 250
STIM2: 250
STIM3: 158
STIM4: 146 | 180±10 % (90±10 %(Vp)) | 80±10% | 200±20%
(100±20%
(Vp)) | 228±20%
(114±20%
(Vp)) | (Note 2) |
| Maximum output
voltage (volts+/-20%)
at 10KΩ | | TENS 1: 300
TENS 2: 286
STIM1: 310
STIM2: 308
STIM3: 278
STIM4: 276 | 250±10 %
(125±10 %(Vp)) | 112±10% | 210±20%
(105±20%
(Vp)) | 230±20%
(115±20%
(Vp)) | (Note 2) |
| Maximum output
current (mA+/-20%) at
500Ω | TENS 1: 224
TENS 2: 228
STIM1: 232
STIM2: 232
STIM3: 152
STIM4: 140 | $200\pm10 %$
$(100\pm10 %(Ip))$ | $88\pm10%$ | $96\pm20%$ | (Note 2) | | |
| Maximum output
current (mA+/-20%) at
2KΩ | TENS 1:125
TENS 2: 120
STIM1: 125
STIM2: 125
STIM3:79
STIM4: 73 | $90\pm10 % (45\pm10 %(Ip))$ | $40\pm10%$ | $50\pm20%$ | $57\pm20%$ | (Note 2) | |
| Maximum output
current (mA+/-20%) at
10KΩ | TENS 1: 30
TENS 2: 28.6
STIM1: 31
STIM2:30.8
STIM3: 27.8
STIM4: 27.6 | $25\pm10 % (12.5\pm10 %(Ip))$ | $11.2\pm10%$ | $10.5\pm20%$ | $11.5\pm20%$ | (Note2) | |
| Pulse period (mSec) | 20200 | 50-450µs | 120µs | 50-300µs | | (Note 2) | |
| Frequency (Hz) | TENS 1: 33
TENS 2: 5
STIM1:37
STIM2:25
STIM3: 5
STIM4: 50 | 1-150Hz | 77.3Hz | 1-150Hz | (Note 2) | | |

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10

11

12

13

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Table 2: Output Specifications

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16

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| Maximum Phase
charge(µC) at 500Ω | TENS 1: 11
TENS 2: 11
STIM1: 11.4
STIM2: 10.6
STIM3: 22.8
STIM4: 20.4 | 0.045 | 12.78μC @ 500Ω | 0.0288@500Ω(mC) | (Note 2) |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------|--------|--------------------|-----------------|----------|
| Maximum charge
density(mA/cm2) at
500Ω | TENS 1: 0.024
TENS 2: 0.01
STIM1:0.027
STIM2: 0.021
STIM3: 0.021
STIM4: 0.059 | 0.667 | 0.235mA/cm² @ 500Ω | 1.15@500Ω | (Note 2) |
| Maximum average
power
density(mw/cm²) at
500Ω | TENS 1: 1.33
TENS 2: 0.554
STIM1: 1.54
STIM2: 1.13
STIM3: 0.793
STIM4: 2.01 | 0.0046 | 1.38mW/cm² @ 500Ω | 4.32@500Ω | (Note 2) |

As shown in the above comparison Table, the subject device, have the technical characteristics (such as maximum output voltage, maximum output current, maximum average power density) in similarity to the predicate device. Acoordingly, we are substantially equivalent to the predicate device HIVOX OTC Electrical Stimulators Model SEM44-1 (K171803) &Health Expert Electronic Stimulator, Model AST300Cand AST-300D (K133929) &OTC ELECTRICAL STIMULATOR (MT9001) &OTC TENS DEVICE (LT3060),

Design and Technology –The basic design and technology of providing electrical stimulation is the same or similar.

Performance and Specifications – The subject device has similar electrical stimulation and specifications to the predicate device.

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Indications - The indications are same.

Review of Differences:

Note 1:

The "Intended Use" of the subject device is the substantially equivalent to the predicate devices selected TENS

(Transutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscle Stimulation) technologies to the treatment of temporary relef of pain associate with sore and aching muscle performance improvement of heathy muscles respectively. Meanvhile, the" Product Code" of the subject device is the same as the predicate devices. This define does not affect the intended use or normal use of the subject device.

Note 2:

The maximum out voltage and maximum output current under 500 Ω. 2Κ.Ω and 10Κ.Ω resistance of candidate device due to different design. The performance test was conducted to verify the maximum out current of candidate device under the acceptance criteria followed IEC 60601-2-10:2012 +A1:2016+A2:2023 。

The candidate device has also demonstrated the electrical safety by passing 60601-1:2012+A2:2020, IEC 60601-1-11:2020 and IEC 60601-2-10:2012 +A1:2016+A2:2023, therefore, the different maximum out voltage will not affect the electrical safety of the candidate device. We have found 510(K) cleared reference deviceK171803 has difference maximum output voltage and maximum out current with the candidate device, which demonstrate that the design of candidate device doesn't impact and effectiveness.

Pulse Width

The difference in pulse width between the predicate device is having different sensation when delivered to human body. Different p ulse with will lead to different output charge.The bigger pulse width. A large mount of charge will give more obviou

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s sensation to human body, but the charge is still within the required safety performance range according to the safety calculation.

Therefore, the difference does not raise new questions of safety and effectiveness as compared to the predicate devices.

Maximum Phase Charge

The reason that the subject device's phase charge is because the allowed voltage is higher than predicate device's at 5000. However, the subject device's phase charge is still in the safety range. In addition, the negative phase charge are always balanced out. Therefore, the difference does not raise new questions of safety and effectiveness as compared to the predicate devices.

Frequency range

Frequency for the subject device is 5-50Hz and it fals into frequency of 1-150 Hz. So the difference doesn't raise new questions of safety and effectiveness. This difference doesn't raise new questioness. As demonstrated, the differences between the subject and predicate devices do not affect the intended use or aller the device. There are no new safety or effectiveness issues concerning the subject device, which offers substant technical specifications, features, intended use, safety, and effectiveness as the predicate device. Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

Note 3:

Although the " Number of Output Modes", "Number of Output Channels" of the subject device are a little different from the predicate devices, they are all complaint with requirement of IEC6060-1:2012+A2:2020、IEC 60601-1-2:2014 /AMD1:2020 and IEC 60601-2-10:2012 +A1:2016+A2:2023 standard. So these differences will not raise any safety or effectiveness issue.

Note 4:

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Although the "Weight" and "Dimensions" of the subject devices, these differences are insignificant in the terms of safety or effectiveness.

1. Electrical safety

IEC6060-1:2005+A1:2012+A2:2020 Medical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance.

2) Electromagnetic compatibility (EMC)

IEC 60601-1-2:2014 /AMD1:2020 Medical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance --Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests.

3) Basic Safety and Essential Performance

IEC 60601-1-11:2020: General Requirements For Basic Safety And Essential Performance - Collateral Station of Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment.

IEC 60601-2 10:2012 +A1:2016+A2:2023medical electrical equipments for the basic safety and essential performance of nerve and muscle stimulators.

IEC 60601-1-6 :2010+A1:2013+A2:2020Medical Electrical Equirements For Basic Safety And Essential Performance -Collateral Standard: Usability.

Software Verification and Validating Testing 4)

Software verification and validation testing were conducted as recommended by FDA's Guidance for Industry and FDA

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Staff, "Guidance for the Content of Premarket Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern.

Biocompatibility testing 5)

ISO 10993-1:2009 Biological evaluation of medical devices-Parts 1: Evaluation and testing.

ISO 10993-10:2021 Biological evaluation of medical devices-Parts 10: Tests for skin sensitization

ISO 10993-23:2021 Biological evaluation of medical devices-Parts 10: Tests for irritation

11. Discussion of Non-clinical Tests Performed for Determination of Substantial Equivalence are as follows:

The proposed device is the same as the predicate devices are different. A series of safety and performance tests were conducted on the subject device:

Biocompatibility

Software Validation

Electromagnetic compatibility and electrical safety

Function test (Including output waveform, stimulation parameters and current distribution on

the electrodes)

All the test results demonstrate Election meets the requirements of its pre-defined acceptance criteria and intended uses, and is substantially equivalent to the predicate devices.

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12. Clinical Tests Performed

No clinical test data was used to support the decision of substantial equivalence.

13. Conclusion

The subject devices have all features of the few differences do not affect the safety and effectiveness of the subject devices.

Thus, the subject devices are substantially equivalent to the predicate devices.