Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on pre-programmed stimulation modes and Bluetooth control via a mobile app, with no mention of adaptive algorithms, learning from user data, or AI/ML terminology.

Therapeutic

Yes
The device is used for temporary relief of pain and symptomatic relief of chronic pain, and to stimulate muscles to improve performance, all of which are therapeutic uses.

Diagnostic

No

The device is described as an electro-stimulation therapy device used to stimulate muscles and provide pain relief. It does not mention any function for diagnosis or detection of medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly lists multiple hardware components including the main unit, charging case, charger connector, electrodes, indicator light, main unit cable, and buttons, in addition to the software application.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use/Indications for Use: The intended use clearly states that the device is used to stimulate muscles and provide pain relief. These are applications directly on the human body, not on samples taken from the body.
Device Description: The description details an electrotherapy device that applies electrical pulses through electrodes placed on the body. This is consistent with external therapeutic devices, not devices that analyze biological samples.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes related to diagnosing conditions based on in vitro analysis.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function falls under the category of therapeutic or rehabilitative devices, not diagnostic ones.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Portable Electro-Stimulation Therapy Device, model LGT-232(US) is used to: Stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only.

Portable Electro-Stimulation Therapy Device, model LGT-232(US) in TENS mode is used for:

Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities;
The symptomatic relief and management of chronic, intractable pain associated with arthritis.

Product codes

NGX, NUH, NYN

Device Description

The LGT-232(US) is a lightweight and portable multifunctional electrotherapy device that provides NMES or TENS current. The device consists of the main unit, charging case, charger connector, FDA cleared self-adhesive electrodes (K183154), indicator light, main unit cable, on/off button, decreasing intensity button, and increasing intersity button to complete the function. The device can also be connected to a mobile phone through Bluetooth, and be controlled by the MStim Sport Application on the mobile device to choose the training programs and adjust pulse output intensity. The MSim Sport App can be downloaded from App Store. MStim Sport has up to seven training programs. These include Endurance, Resistance, Strength, Explosive Strength, Potentiation, Training Recovery and Pain Relief programs. The programmed electrical pulses will transfer through electrode plates to the suggested area of the body where the electrodes are placed.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

adults only.

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)

The Device has been evaluated for safety and performance by labbench testing according to the following standards:

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 neve and muscle stimulators.
ANSI IEEE C63.27-2017: American National Standard for Evaluation of Wireless Coexistence
IEC 62133-2: 2017: Secondary cells and batteries containing alkaline or other non-acid electroytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, foruse in portable applications- Part 2: Lithium systems
Biological evaluation of medical device Part 10: Tests forirritation and skin sensitization (ISO 10993- 10: 2010)
Biological evaluation of medical device Part 5: Cytotoxicity test- In vitro method (ISO 10993-5: 2009)

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

Not Found

Predicate Device(s)

K170903, K200727

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

October 8, 2020

Guangzhou Longest Science & Technology Co., LTD. % Jet Li Regulation Manager Guangzhou KEDA Biological Tech Co., LTD. 6F, No. 1 TianTai Road, Science City, LuoGang District Guangzhou, Guangdong China

Re: K201845

Trade/Device Name: Portable Electro-Stimulation Therapy Device, Model: LGT-232(US) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX, NUH, NYN Dated: July 9, 2020 Received: July 13, 2020

Dear Jet Li:

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.

Amber Ballard, PhD 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) K201845

Device Name

Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)

Indications for Use (Describe)

The Portable Electro-Stimulation Therapy Device, model LGT-232(US) is used to: Stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only.

Portable Electro-Stimulation Therapy Device, model LGT-232(US) in TENS mode is used for:

Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities;
The symptomatic relief and management of chronic, intractable pain associated with arthritis.

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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510(k) Summary

This summary of 510(K) is being submitted in accordance with the requirement of 21 CFR 807.92.

1. Date of the summary prepared: 2020-10-05

2. Submitter'sInformation

Company Name: Guangzhou Longest Science & Technology CO., Ltd. Address: 5&6F, Building B4, No.11, Kaiyuan Avenue, Science City, Guangzhou Hi-tech Industrial Development Zone, 510530 Guangzhou, Guangdong Province, P.R. China Phone: +86 020 6635 3999 Fax: +86 020 6635 3920

URL: www.longest.cn E-mail: qzlongest@126.com Contact Person: Xiaoping Luo (Deputy general manager) E-mail: service@longest.cn

Application Correspondent:

Company: Guangzhou KEDA Biological Tech Co., Ltd. Address: 6F, No.1 TianTai road, Science City, LuoGang District, GuangZhouCity, China

Contact Person: Mr. Jet Li Title: Regulation Manager Tel: +86-18588874857 Email: med-jl@foxmail.com

3. Subject Device Information

Type of 510(k) submission: Traditional Common Name: Powered muscle stimulator Trade Name: Portable Electro-Stimulation Therapy Device, Model: LGT-232(US) Classification Name: Stimulator, Muscle, Powered, For Muscle Conditioning Review Panel: Neurology, Physical Medicine Product Code: NGX, NUH, NYN Regulation Number: 890.5850 Regulation Class: 2

4. Predicate Device Information

| Sponsor | DJO, LLC | Shenzhen As-Tec Technology
Co., Ltd. |

---------	----------	-----------------------------------------

4

| Device Name | Compex Wireless USA | TENS and Muscle Stimulator
(Model AS8012) |
|----------------------|---------------------|----------------------------------------------|
| 510(k) Number | K170903 | K200727 |
| Product Code | NGX, NUH, NYN | NUH, NGX |
| Regulation
Number | 21 CFR § 890.5850 | 21 CFR § 890.5850 |
| Regulation Class | 2 | 2 |

5. Device Description

The LGT-232(US) is a lightweight and portable multifunctional electrotherapy device that provides NMES or TENS current. The device consists of the main unit, charging case, charger connector, FDA cleared self-adhesive electrodes (K183154), indicator light, main unit cable, on/off button, decreasing intensity button, and increasing intersity button to complete the function. The device can also be connected to a mobile phone through Bluetooth, and be controlled by the MStim Sport Application on the mobile device to choose the training programs and adjust pulse output intensity. The MSim Sport App can be downloaded from App Store. MStim Sport has up to seven training programs. These include Endurance, Resistance, Strength, Explosive Strength, Potentiation, Training Recovery and Pain Relief programs. The programmed electrical pulses will transfer through electrode plates to the suggested area of the body where the electrodes are placed.

6. Indications for Use

The Portable Electro-Stimulation Therapy Device, model LGT-232(US) is used to: Stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only.

Portable Electro-Stimulation Therapy Device, model LGT-232(US) in TENS mode is used for: 1) Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities;

The symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

7. Test Summary

The Device has been evaluated for safety and performance by labbench testing according to the following standards:

IEC 60601-1-2: 2014: Medical Electrical Equipment -Part 1-2: General requirements for basic 1) safety and essential performance. Collateral Standard: Electromagnetic Compatibility
1. IEC 60601-1:2005: Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
1. 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

5

1. IEC 60601-2-10: 2012: Medical Electrical Equipment - Part 2: Particular requirements for the basic safety and essential performance of neve and muscle stimulators.
1. ANSI IEEE C63.27-2017: American National Standard for Evaluation of Wireless Coexistence
IEC 62133-2: 2017: Secondary cells and batteries containing alkaline or other non-acid electroytes -6) Safety requirements for portable sealed secondary cells, and for batteries made from them, foruse in portable applications- Part 2: Lithium systems
1. Biological evaluation of medical device Part 10: Tests forirritation and skin sensitization (ISO 10993- 10: 2010)
1. Biological evaluation of medical device Part 5: Cytotoxicity test- In vitro method (ISO 10993-5: 2009)

8. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, mode ofoperation, and intended use of the Portable Electro-Stimulation Therapy Device, Model: LGT-232(US) are substantially equivalent to the predicate devices quoted above.

The differences between the subject device and predicate device do not raise new issues of safety or effectiveness.

6

Characteristic	New Device	Predicate Device I	Predicate Device II	Comparison

510 (K) Number	(To Be Assigned)	K170903	K200727	N/A
Device Name and
Model	Portable Electro-Stimulation
Therapy Device, Model: LGT-
232(US)	Compex Wireless USA	TENS and Muscle Stimulator
(Model AS8012)	N/A
Manufacturer	Guangzhou Longest Science &
Technology CO., Ltd.	DJO, LLC	Shenzhen As-Tec Technology
Co., Ltd.	N/A
Prescription/OTC	OTC	OTC	OTC	Same
Indications for use	The Portable Electro-Stimulation
Therapy Device, model LGT-
232(US) is used to: Stimulate
healthy muscles in order to
improve or facilitate muscle
performance. It is to be used by
adults only.
Portable Electro-Stimulation
Therapy Device, model LGT-
232(US) in TENS mode is used
for:

Temporary relief of pain
associated with sore and aching
muscles due to strain from | The Compex Wireless USA is an
Over-The-Counter device intended
to stimulate healthy muscles in order
to improve or facilitate muscle
performance. It is to be used by
adults only.
The Compex Wireless USA is not
intended for adjunctive therapy in the
treatment of medical diseases and
conditions of any kind. None of the
Compex Wireless USA stimulation
programs are designed for injured or
disease afflicted muscles.
Its use on such muscles is
contraindicated. The work imposed
on the muscles by the Compex | TENS(Transcutaneous Electric
Nerve Stimulation):
To be used for temporary relief
of pain associated with sore
and aching muscles in the
shoulder, waist, back, upper
extremities (arm), and lower
extremities (leg) due to strain
from exercise or normal
household work activities.
PMS(Powered Muscle
Stimulation):
It is intended to be used to
stimulate healthy muscles in | Different, but does
not raise different
questions of safety and
effectiveness. | |
| Characteristic | New Device | Predicate Device I | Predicate Device II | Comparison | |
| | exercise or normal household
and work activities;
The symptomatic relief
and management of chronic,
intractable pain and reliefof pain
associated with arthritis. | Wireless USA programs is definitely
not suitable for rehabilitation and
physiotherapy. The Compex
Wireless USA electrical impulses
allow the triggering of action
potentials on motoneurones of motor
nerves (excitations). These
excitations of motoneurones are
transmitted to the muscle fibers via
the motor endplate where they
generate mechanical muscle fiber
responses that correspond to
muscle work. Depending on the
parameters of the electrical
impulses (pulse frequency, duration
of contraction, duration of rest, total
session duration), different types of
muscle work can be imposed on the
stimulated muscles. The Compex
Wireless USA may therefore be
considered a technique of muscle
training.

The Compex Wireless USA TENS is
used for:

Stimulation
Module:2x60 [g]
Docking Station 800[g] | 72g | Different, but does
not raise different
questions of safety and
effectiveness.
See Note 8. | |
| Housing Materials
and Construction | ABS | not publicly available | ABS+Stainless iron | Different, but does
not raise different
questions of safety
and effectiveness.
See Note 8. | |
| Waveform | P1- P7:
Symmetrical biphasic pulse | -Endurance:
Symmetrical Biphasic
-Resistance:
Symmetrical Biphasic
-Strength:
Symmetrical Biphasic
-Explosive Strength:
Symmetrical Biphasic
-Potentiation:
Symmetrical Biphasic
-Training Recovery (same | Pulsed, symmetric, biphasic | Different, but does
not raise different
questions of safety and
effectiveness.
See Note 4. | |
| Characteristic | New Device | Predicate Device I | Predicate Device II | Comparison | |
| | | as Active Recovery):
Symmetrical Biphasic
-Competition Recovery (same as
Recovery Plus):
Symmetrical Biphasic
-Pre-Warmup Program:
Symmetrical Biphasic
-Muscle Relaxation (same
as Massage):
Symmetrical Biphasic
-Pain relief TENS (same
as FM): Balanced,
asymmetrical Biphasic | | | |
| Shape | Rectangular, with interphase interval | -Endurance:
Rectangular
-Resistance:
Rectangul ar | Rectangular, with interphase interval | Same | |
| Characteristic | New Device | Predicate Device I | Predicate Device II | Comparison | |
| | | -Strength:
Rectangular | | | |
| | | -Explosive Strength:
Rectangular | | | |
| | | -Potentiation:
Rectangular | | | |
| | | -Training Recovery:
Rectangular | | | |
| | | -Competiti on
Recovery:
Rectangul ar | | | |
| | | -Pre-W arm up:
Rectangular | | | |
| | | -Muscle Relaxation:
Rectangular | | | |
| | | -Pain relief TENS (same
as FM): | | | |
| Characteristic | New Device | Predicate Device I | Predicate Device II | Comparison | |
| Maximum Output
Voltage | For P1:
46.23V ±10% @ 500Ω ;
102.9V ±10% @2ΚΩ;
108.75V±10% @ 10ΚΩ | Endurance:
60 V ±10% @ 500Ω
165 V±10% @ 2 ΚΩ
165 V±10% @ 10 ΚΩ | For TENS mode and PMS
mode:
49.6V±20% @500Ω;
90V±20% @2kΩ;
120V±20% @10kΩ | Different, but does
not raise different
questions of safety and
effectiveness.
See Note 5. Remarks:
Compared with
predicate device I:
P1 is compared to
Endurance; | |
| | For P2:
45.98V±10% @ 500Ω
104.45V ±10% @ 2ΚΩ;
108.75V±10% @ 10ΚΩ | Resistance:
60 V ±10% @ 500Ω
165 V ±10% @ 2 ΚΩ
165 V ±10% @ 10 ΚΩ | | P2 is compared to
Resistance mode; | |
| | For P3:
45.76 V ±10% @ 500Ω;
103V ±10% @ 2ΚΩ;
108.7V±10% @ 10ΚΩ | Strength:
60 V±10% @ 500Ω
165 V±10% @ 2 ΚΩ
165 V ±10% @ 10 ΚΩ | | P3 is compared to Strength
mode; | |
| | For P4:
45.76 V ±10% @ 500Ω; | Explosive Strength:
60 V±10% @ 500Ω | | P4 is compared to
Explosive Strength mode;
P5 is compared to
Potentiation mode;
P6 is compared to
Training Recovery;
P7 is compared to Pain
Relief TENS mode | |
| Characteristic | New Device | Predicate Device I | Predicate Device II | Comparison | |
| | 103V ±10% @ 2KΩ; | 165 V ±10% @ 2 kΩ | | Compared with predicate
device II:
P1 to P6 is compared
to PMS mode;
P7 is compared to
TENS mode; | |
| | 109.05V±10% @ 10KΩ | 165 V ±10% @ 10 kΩ | | | |
| | | | | | |
| | | | | | |
| | For P5:
45.74V±10% @ 500Ω; | Potentiation:
60 V ±10% @ 500Ω | | | |
| | 103.15V ±10% @ 2KΩ; | 152 V ±10% @ 2 kΩ | | | |
| | 108.6V±10% @ 10KΩ | 136 V ±10% @ 10 kΩ | | | |
| | | | | | |
| | For P6:
45.73V±10% @ 500Ω; | Training Recovery:
60 V±10% @ 500Ω | | | |
| | 103.05V±10% @ 2KΩ; | 165 V±10% @ 2 kΩ | | | |
| | 108.5V±10% @ 10KΩ | 165 V±10% @ 10 kΩ | | | |
| | | Competition Recovery:
60 V±10% @ 500Ω
165 V±10% @ 2 kΩ
165 V±10% @ 10 kΩ
Pre Warmup | | | |
| Characteristic | New Device | Predicate Device I | Predicate Device II | Comparison | |
| | | 60 V ±10% @ 500Ω | | | |
| | | 165 V ±10% @ 2 kΩ | | | |
| | | 165 V ±10% @ 10 kΩ | | | |
| | | Muscle Relaxation: | | | |
| | | 60 V ±10% @ 500Ω | | | |
| | | 165 V ±10% @ 2 kΩ
165 V ±10% @ 10 kΩ | | | |
| | For P7: | Pain Relief TENS: | | | |
| | 47.40V ±10% @ 500Ω; | 180[V] peak ±10% on 10[kΩ]; | | | |
| | 104.45V ±10% @ 2KΩ; | 170[V] peak±10% on 2[kΩ] | | | |
| | 109.3V±10% @ 10KΩ | 58[V] peak ±10% on 500[Ω] | | | |
| Maximum Output
Current | For P1: | Endurance: | For TENS mode and PMS
mode:
99.2mA±20% @500Ω;
45mA±20% @2kΩ;
12mA±20% @10kΩ | Different, but does
not raise different
questions of
safety and
effectiveness.
See Note 5. | |
| | 92mA±10% @500Ω; | 116 mA ±10% @ 500Ω | | | |
| | 51mA±10% @ 2KΩ; | 80 mA±10% @ 2 kΩ | | | |
| | 11mA±10% @ 10KΩ | 15 mA±10% @ 10 kΩ | | | |
| Characteristic | New Device | Predicate Device I | Predicate Device II | Comparison | |
| | | | | | |
| | | | | | |
| | | | | Remarks:
Compared with
predicate device I:
P1 is compared to
Endurance;
P2 is compared to
Resistance mode;
P3 is compared to Strength
mode;
P4 is compared to
Explosive Strength mode;
P5 is compared to
Potentiation mode;
P6 is compared to
Training Recovery;
P7 is compared to Pain
Relief TENS mode | |
| | For P2:
92mA±10% @ 500Ω;
52mA ±10% @ 2KΩ;
11mA±10% @ 10KΩ | Resistance:
116 mA±10% @ 500Ω
80 mA ±10% @ 2 kΩ
17 mA ±10% @ 10 kΩ | | | |
| | For P3:
92mA±10% @ 500Ω;
52mA ±10% @ 2KΩ;
11mA±10% @ 10KΩ | Strength:
113 mA ±10% @ 500Ω
80 mA ±10% @ 2 kΩ
15 mA ±10% @ 10 kΩ | | | |
| | For P4:
92mA±10% @ 500Ω;
52mA ±10% @ 2KΩ;
11mA±10% @ 10KΩ | Explosive Strength:
81 mA±10% @ 500Ω
81 mA±10% @ 2 kΩ
15 mA ±10% @ 10 kΩ | | | |
| Characteristic | New Device | Predicate Device I | Predicate Device II | Comparison | |
| | For P5:
92mA±10% @ 500Ω;
52mA ±10% @ 2KΩ;
11mA±10% @ 10KΩ

For P6:
92mA±10% @ 500Ω;
52mA±10% @ 2KΩ;
11mA±10% @ 10KΩ | Potentiation:
117 mA ±10% @ 500Ω
80 mA±10% @ 2 kΩ
16 mA±10% @ 10 kΩ
Training Recovery:
116 mA±10% @ 500Ω
81mA±10% @ 2 kΩ
16 mA±10% @ 10 kΩ
Competition Recovery:
116 mA ±10% @ 500Ω
81 mA±10% @ 2 kΩ
16 mA ±10% @ 10 kΩ | | Compared with
predicate device II:

P1 to P6 is compared to
PMS mode;

P7: 70 μs | Endurance:
200 to 400 [μs]
Resistance:
200 to 400 [μs]
Strength:
200 to 400 [μs]
Explosive Strength:
200 to 400 [μs]
Potentiation:
200 to 400 [μs]
Training Recovery:
200 to 400 [μs]
Competition Recovery:
200 to 400 [μs]
Pre Warmup | Positive phase: 80 μs ± 10%
Negative phase: 80 μs ± 10% | Different, but does not raise different questions of safety and effectiveness.
See Note 6
Remarks:
Compared with predicate device I:
P1 is compared to Endurance;
P2 is compared to Resistance mode;
P3 is compared to Strength mode;
P4 is compared to Explosive Strength mode;
P5 is compared to Potentiation mode; | |
| Characteristic | New Device | Predicate Device I | Predicate Device II | Comparison | |
| | | 200 to 400 [μs]
Muscle Relaxation:
200 to 400 [μs]
Pain Relief TENS:
70 to 300[μs] (measured
at 50% of positive pulse) | | P6 is compared to
Training Recovery;
P7 is compared to Pain
Relief TENS mode

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Comparison in Detail(s):

Note 1 (Power Source(s), Method of Line Current Isolation, Number of Channels for Micro current stimulation, Synchronous or Alternating, Regulated Current or Regulated Voltage):

For Power Sources: The power source is the operation of the device, it does not affect the output of the micro current. And the device complies with IEC 60601-1 requirements for evaluation of safety. So, such a minor different question of safety and effectiveness.

For Method of Line Current Isolation. The subject device shock isolation protection for operator and patient according to lECC0001-1 standard requirement. So, such a minor difference does not raise different question of safety and effectiveness.

For Number of Channels for Micro current stimulation of channels of ourset the treatment, and the design of subject device comply with IEC60601-2-10 for performance requirement. So, such a minor different question of safety and effectiveness.

For Synchronous or Alternating: There is only one current stimulation in subject device. It will not cause safety issue of output current by synchronous or alternating stimulation of the subject device comply with IEC6001-2-10 for performance requirement. So, such a minor difference does not raise different question of safety and effectiveness.

For Regulated Current or Regulated Voltage: There is minor difference output wareom regulation by regulation by regulated current or regulated votage. And the design of subject device with IEC60601-2-10 for performance requirement. So, such a minor difference does not raise different question ofsafety and effectiveness.

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Note 2 (Automatic Overload Trip, Automatic Shut Off, Patient Override Control):

The design of the Automatic Overiod Trip, Shut Offent Deride Control are different but subject device has an automatic shutdown function and an overload protection function, which can prevent the patient overide control design can make the operator shut down the device output manually at any time. The difference would not affectiveness of the subject device.

Note 3 (Timer Range):

The design of the time range is based on the intered use. For the Portable Electro-Stimulation Therapy Device. Model: LGT-232(US), the operating time is aqustable by the operator according to phe difference in timer setting range would not impact its safety and effectiveness compared to the predicate devices.

Note 4 (Waveform):

Both asymmetrical biphasic wave and symmetrical biphasic wave are common waveforms of low frequency electrical stimulation.

For NVES mode, both the subject device are using a symmetrical biphasic wae. For TENS mode, the predicate device is using a balanced, asymmetical biphasic wae and the susing a symmetrical biphasic wae. But as long as it has a specific frequency and pulse with, the therapeutic effect can also be achieved. So, the difference would not impact its safety and effectiveness.

Note 5 (Maximum Output Voltage and Maximum Output Current):

The effect of micro current stimulation is detemined output warent. There is some difference between the cuput voltage and current of the subject deice compared with the predicate device II (K20727) as a compenentary predicate device, the max output oblage and current are subject device. Also, the output voltage and current of the subject device compy with standard requirement of IEC60601-2-10. Therefore, the difference would not affect safety and effectiveness of the subject device.

Note 6 (Frequency, Pulse-width and Pulse duration):

Frequency range: There is a minor difference between the subject device and the predicate device II (2007). This minor difference does not raise different questions of safety and effectiveness.

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Pulse width range: The stimulation is deternined by pulse width of micro-current output waveform. Frequency and oulse are the time parameter of the wavelom. There is only little difference between the public device and the predicate device, and the same effect can still be obtained. Also, the subject device with EC 60601-2-10 forsafety enaluation. Therefore, the minor difference in the pulse width range would not affect the safety and effectiveness of subject device.

Pulse duration: There is only little difference between of the subject device and the predicate device (K31077), the pulse period in a complete cycle of the outseduration difference only affects the number of pulses per burst in one cycle of the output wavelom. Hower, the operator can adjust the device the treatment time range according to their need. And the subject device complies with IEC 60601-1, and IEC60601-2- 10 for safety evaluation. The pulse duration would not affect the safety and effectiveness of subject device.

Note 7 (Maximum current density, Maximum power density and Net Charge):

The effect of the micro-current stimulation is delemined by the micro-current. The difference between the value of maximum current density and maximum power device and the predicate device is due to electrode padsize, but the value of the maximum current density and the maximum power device are within range and the maximum power density meets with the maximum allowed rabel alled 0.25 (W/cm²) required in FDA guidance. The subject device and predicate device are substantially equivalence on these parameters.

Note 8 (Console weight, Housing Materials and Construction):

There are minor differences betweend the predicate devices on devices on device weight and its housing material and construction. But the subject device complies with EC60601-1, and IEC60601-2-10 Standard requirement. These differences would not impact the safety and effectiveress of the subject device.

Finial Conclusion:

The subject device Portable Electro-Stimulation Therapy Device, Model: LGT-232(US) is substantially equivalent to the predicate devices.