(783 days)
Not Found
No
The summary describes a standard electro-stimulation device with a mobile app for control. There is no mention of AI or ML being used for treatment parameter selection, analysis of patient data, or any other function. The device operates based on pre-programmed modes and user adjustments.
Yes
The device is explicitly referred to as a "Portable Electro-Stimulation Therapy Device" in its name and description, and its intended uses are for pain relief and muscle performance, which are therapeutic applications.
No
The device is used for therapeutic purposes (pain relief and muscle stimulation) rather than for diagnosing a medical condition.
No
The device description explicitly states that the system is made up of a mobile app, a main unit, and electrodes, indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Portable Electro-Stimulation Therapy Device, model LGT-231, works by applying electrical stimulation to the skin to affect nerves and muscles. It does not analyze any biological samples from the body.
- Intended Use: The intended uses are for pain relief (TENS) and muscle stimulation (NMES), both of which are therapeutic applications, not diagnostic ones based on in vitro analysis.
The device is a therapeutic device that interacts with the body externally, not an IVD that analyzes samples taken from the body.
N/A
Intended Use / Indications for Use
Portable Electro-Stimulation Therapy Device, model LGT-231 is to be used by adults only and has two modes NMES and TENS.
NMES is used to: stimulate healthy muscles in order to improve or facilitate muscle performance.
TENS is used to:
- Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities.
- Symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
Product codes
NGX, NUH, NYN
Device Description
The Portable Electro-Stimulation Therapy Device, model LGT-231 is a dual channel stimulator which sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin with two operational modes and powered by rechargeable lithium battery; the device system is made up of mobile app MStim Reha, main unit and electrodes.
The Mobile App MStim Reha provides access to treatment controls for Portable Electro-Stimulation Therapy Device from a compatible device for selecting a pre-programmed output mode, adjusting frequency, pulse width and treatment time. Software operating environment of Mobile App MStim Reha are Android 4.3 or later mobile phone, with 4.0 Bluetooth and iOS 8.0 or later iPhone mobile phone, with 4.0 Bluetooth. Click the MStim Reha Application installation package on the phone to install the application. MStim Reha Application and the device can be connected via Bluetooth.
The main unit provides access to adjust the intensity up or down, put ON/OFF the main unit.
The two modes that Portable Electro-Stimulation Therapy Device, model LGT-231 employs are neuromuscular electrical stimulation (NMES) and transcutaneous electrical stimulation (TENS). Neuromuscular electrical stimulation (NMES) and transcutaneous electrical stimulation (TENS) target different nerve groups of the body.
TENS is specifically targets the sensory nerves, which are responsible for sending pain signals to the brain. TENS use tiny electrical impulses sent through the skin to nerves to modify the pain perception. TENS does not cure any physiological problem; it only helps control the pain, this activates the underlying sensory nerves. Self-adhesive electrodes are placed on the skin close to the area of pain.
NMES targets the muscle itself, specifically through the motor nerves. This allows the NMES machine to create a muscle contraction to recruit more muscle fibers when training: warming up or recovering. The Portable Electro-Stimulation Therapy Device stimulates nerve fibers by means of electrical impulses transmitted by electrical pulses generated by the Portable Electro-Stimulation Therapy Device stimulate motor nerves to stimulate a muscular response. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, and total session duration), different types of muscle work can be imposed on the stimulated muscles. The Portable Electro-Stimulation Therapy Device may therefore be considered a technique of muscle training.
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)
Non-clinical verification testing of the Portable Electro-Stimulation Therapy Device, model: LGT-231 included electrical, mechanical, and software tests to show the device meets its design specifications. Validation and performance testing validates that the device meets its user needs. Verification and validation test results established that the device meets its intended use, that it is as safe, as effective, and performs as well as the predicate devices, and that no new issues of safety and effectiveness were raised. The Portable Electro-Stimulation Therapy Device, model: LGT-231 was designed, verified, and validated according to the company's Design Control process and has been subjected to extensive safety and performance testing as shown in the test results provided in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 shows the logo for the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION".
September 17, 2020
Guangzhou Longest Science & Technology Co., Ltd. % You Yiiie Manager Oimmig Medical Consulting Service Co., Ltd RM.1711, Building K, NO.101 Science Ave International Creative Valley Guangzhou, 510663 Cn
Re: K182020
Trade/Device Name: Portable Electro-Stimulation Therapy Device Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX, NUH, NYN Dated: July 27, 2020 Received: July 27, 2020
Dear You Yijie:
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.
Vivek Pinto, PhD 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
2
Indications for Use
510(k) Number (if known) K182020
Device Name
Portable Electro-Stimulation Therapy Device, model LGT-231
Indications for Use (Describe)
Portable Electro-Stimulation Therapy Device, model LGT-231 is to be used by adults only and has two modes NMES, TENS.
NMES is used to: stimulate healthy muscles in order to improve or facilitate muscle performance.
TENS is used to:
-
Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities.
-
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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3
510(K) Summary
1. Submitter's Information
Establishment Registration Information
Name: Guangzhou Longest Science & Technology Co., Ltd. Address: 5&6f, Building B4, No.11, Kaiyuan Avenue Science City, Hi-Tech Industrial Zone, Guangzhou, Guangdong CHINA
Contact Person of applicant
Name: Xiaobing Luo Address: 5&6f, Building B4, No.11, Kaiyuan Avenue Science City, Hi-Tech Industrial Zone Guangzhou, Guangdong CHINA TEL: +86 020-66353999 FAX: +86 020-66353999 Email: gzlongest@126.com
Contact Person of the Submission:
Name: You Yijie Address: RM.1711, Building K, NO.101 Science Ave International Creative Valley Development Zone, Guangzhou China TEL: +86 020-8224 5821 FAX: +86 020-8224 5821 Email: Jet.you@qimmiq-med.com
Contact Person to prepare summary:
Name: You Yijie Address: RM.1711, Building K, NO.101 Science Ave International Creative Valley Development Zone, Guangzhou China TEL: (+86) 020-8224 5821 FAX: (+86) 020-8224 5821 Email: Jet.you@qimmiq-med.com Date to prepare: 7/5/2018
2. Device Information
Type of 510(K) submission: Traditional Trade Name: Portable Electro-Stimulation Therapy Device Model: LGT-231 Requlation name: Powered muscle stimulator. Transcutaneous electrical nerve stimulator for pain relief. Review panel: Physical Medicine, Neurology Product code: NGX, NUH, NYN Regulation Class: II Regulation Number: 21 CFR 890.5850, 21 CFR 882.5890
3. Predicate Device Information
4
| 510(k) submitter/holder: | DJO, LLC |
|---|---|
| 510(K) Number: | K170918 |
| Device: | Compex Sport Elite |
| Trade name: | Compex Sport Elite |
| Regulation name: | Powered muscle stimulator. Transcutaneous electrical nerve stimulator for pain relief. |
| Review panel: | Physical Medicine, Neurology |
| Product code: | NGX, NUH, NYN |
| Regulation Class: | II |
| Regulation Number: | 21 CFR 890.5850, 21 CFR 882.5890 |
4. Device description
The Portable Electro-Stimulation Therapy Device, model LGT-231 is a dual channel stimulator which sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin with two operational modes and powered by rechargeable lithium battery; the device system is made up of mobile app MStim Reha, main unit and electrodes.
The Mobile App MStim Reha provides access to treatment controls for Portable Electro-Stimulation Therapy Device from a compatible device for selecting a pre-programmed output mode, adjusting frequency, pulse width and treatment time. Software operating environment of Mobile App MStim Reha are Android 4.3 or later mobile phone, with 4.0 Bluetooth and iOS 8.0 or later iPhone mobile phone, with 4.0 Bluetooth. Click the MStim Reha Application installation package on the phone to install the application. MStim Reha Application and the device can be connected via Bluetooth.
The main unit provides access to adjust the intensity up or down, put ON/OFF the main unit.
The two modes that Portable Electro-Stimulation Therapy Device, model LGT-231 employs are neuromuscular electrical stimulation (NMES) and transcutaneous electrical stimulation (TENS). Neuromuscular electrical stimulation (NMES) and transcutaneous electrical stimulation (TENS) target different nerve groups of the body.
TENS is specifically targets the sensory nerves, which are responsible for sending pain signals to the brain. TENS use tiny electrical impulses sent through the skin to nerves to modify the pain perception. TENS does not cure any physiological problem; it only helps control the pain, this activates the underlying sensory nerves. Self-adhesive electrodes are placed on the skin close to the area of pain.
NMES targets the muscle itself, specifically through the motor nerves. This allows the NMES machine to create a muscle contraction to recruit more muscle fibers when training: warming up or recovering. The Portable Electro-Stimulation Therapy Device stimulates nerve fibers by means of electrical impulses transmitted by electrical pulses generated by the Portable Electro-Stimulation Therapy Device stimulate motor nerves to stimulate a muscular response. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, and total session duration), different types of muscle work can be imposed on the stimulated muscles. The Portable Electro-Stimulation Therapy Device may
5
therefore be considered a technique of muscle training.
5. Principle of operation:
The Portable Electro-Stimulation Therapy Device, model LGT-231 sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin and powered by rechargeable lithium battery. When used in TENS mode, it is specifically targets the sensory nerves, which are responsible for sending pain signals to the brain; and it uses tiny electrical impulses sent through the skin to nerves to modify the pain perception and finally helps control the pain. IN NMES mode. Portable Electro-Stimulation Therapy Device stimulates nerve fibers by means of electrical impulses transmitted by electrodes, the electrical pulses generated by the Portable Electro-Stimulation Therapy Device stimulate motor nerves to stimulate a muscular response and to create a muscle contraction to recruit more muscle fibers when training.
6. Indications for Use
Portable Electro-Stimulation Therapy Device, model LGT-231 is to be used by adults only and has two modes NMES and TENS.
NMES is used to: stimulate healthy muscles in order to improve or facilitate muscle performance.
TENS is used to:
-
Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities.
-
Symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
7. Summary of technological characteristics of device compared to the predicate devices (K170918)
| Characteristic | Subject device
Present application
(Portable
Electro-Stimulation
Therapy Device, model
LGT-231) | Predicate device
(K170918, Compex
Sport Elite) | Discussion of difference | |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Guangzhou Longest
Science & Technology
Co., Ltd | DJO, LLC | / | |
| Picture | Image: Portable Electro-Stimulation Therapy Device, model LGT-231 | Image: Compex Sport Elite | / | |
| Classification | | 21 CFR 890.5850,
21 CFR 882.5890 | 21 CFR 890.5850,
21 CFR 882.5890 | Same |
| Prescription/OTC | | OTC | OTC | Same |
| Product Code | | NGX, NUH, NYN | NGX, NUH, NYN | Same |
| FDA Class | | II | II | Same |
| Intended Use | | Portable
Electro-Stimulation
Therapy Device, model
LGT-231 is to be used by
adults only and has two
modes NMES and TENS.
NMES is used to: stimulate
healthy muscles in order to
improve or facilitate muscle
performance.
TENS is used to:
- Temporary relief of pain
associated with sore and
aching muscles due to
strain from exercise or
normal household and
work activities. - Symptomatic relief and
management of chronic,
intractable pain and relief
of pain associated with
arthritis. | NMES: The Compex Sport
Elite is intended to
stimulate healthy muscles
in order to improve or
facilitate muscle
performance. The work
imposed on the muscles by
the Compex Sport Elite
programs is not suitable for
rehabilitation or
physiotherapy.
TENS: The Compex Sport
Elite TENS is intended for:
• Temporary relief of pain
associated with sore and
aching muscles due to
strain from exercise or
normal household and
work activities
• They symptomatic relief
and management of
chronic, intractable pain
and relief of pain
associated with arthritis.
The Compex® Sport Elite
is an Over-The-Counter
device to be used by adults
only. | Same |
| target population | | adults | adults | Same |
| Power Source | | Rechargeable lithium
battery 3.7V | Rechargeable Ni-Mh
Battery 4.8V | Similar
The proposed device was
demonstrated electromagnetic
compatility and electrical safety
by the testing. The difference
does not raise the issue of
product's safety and
effectiveness. |
| Method of line
current isolation | | N/A (battery operated
device) | N/A (battery operated
device) | Same |
| Patient
Leakage
Current | Normal
condition | N/A (battery operated
device) | N/A (battery operated
device) | Similar
The proposed device was
demonstrated electrical safety by
passing ANSI AAMI ES60601-1
and IEC 60601-2-10 tests. The
difference does not raise the
issue of product's safety and
effectiveness. |
| | Single fault
condition | N/A (battery operated
device) | N/A (battery operated
device) | Same |
| Number
of Output
Channels | Number | Two | Four | Different |
| | | | | More channels means it can be
applied on more different body
sides at the same time, and all
output channel works
independently from each other,
the proposed device has less
channels than equivalent device,
this can be addressed by applied
two proposed device, therefore,
the different channel number will
not affect the safety and
effectiveness of the proposed
device. |
| Synchronous
or
Alternating? | | Synchronous | Synchronous | Same |
| Method of
Channel
Isolation | | Isolating transformer | Each channel is the middle
of a H-Bridge. Except when
it is activated, each
channel is always in high
impedance state. | Similar
The proposed device was
demonstrated electrical safety by
passing ANSI AAMI ES60601-1
and IEC 60601-2-10 tests. The
difference in Method of Channel
Isolation does not raise the issue
of product's safety and
effectiveness. |
| Number of Output
Modes | | Two (TENS and NMES) | two (TENS and NMES) | Same |
| Regulated Current or
Regulated Voltage? | | Current | Current | Same |
| Software/Firmware/Micropr
ocessor Control? | | Yes | Yes | Same |
| Automatic Overload Trip? | | Yes | Yes | Same |
| Automatic No-Load
Trip? | | Yes | Yes | Same |
| Automatic Shut Off? | | "On/Off" button | "On/Off" switch | Same |
| User Override Control? | | Yes | Yes | Same |
| Indicator | On/Off Status? | Yes | Yes | Same |
| Display | Low Battery? | Yes | Yes | Same |
| | Voltage/ Current
Level? | Yes (on app) | Yes | Same
System validation
testing scenarios
covering mitigation of
wireless risks in
accordance with
RED were added to our full
system testing protocol to ensure
safe and effective use. |
| Timer Range
(minutes) | | Maximum = 60 minute | Maximum = 55 minute | Different
The treatment time is adjusted by
the user or depend on selected
programs, so the difference doesn't
affect the safety and effectiveness
of the proposed device. |
| | Compliance with 21 CFR
898? | Yes | Yes | Same |
| | ANSI AAMI ES60601-1 | Yes | Yes | Same |
| IEC 60601-2-10 | Yes | Yes | Same | |
| Weight | 120g (only main unit) | 300 g | Different
The Weight will not affect the
safety and effectiveness of the
proposed device | |
| Dimensions (mm)
(W x H x D) | 62 (W) × 122 (L) × 27 (H)
(mm) | 99 x 142 x 36 (mm)
3.9 x 5.6 x 1.4 (in) | Different
The dimensions will not affect the
safety and effectiveness of the
proposed device | |
| Housing Materials and
Construction | Casing: Plastic (PC+ABS,
with PMMA on the button
panel)
Buttons: ABS
Light pipe: PC | Casing:
Plastic (ABS, with PMMA
on the windows)
Buttons:
Silicon, rubber
Battery Pack:
Rigid, ABS housing
around the battery
cells
Battery contacts:
SK5 steel | Similar
The Housing Materials and
Construction form the basic
construction and ensure the basic
safety of device, since the
proposed device was
demonstrated electrical safety by
passing ANSI AAMI ES60601-1
and IEC 60601-2-10 tests, the
existed difference will not affect
the safety of the proposed device. | |
| Programs | NMES:
TENS:
- Normal
- Sweep
- Random
- Alternation represents
different frequency
modulation methods) | NMES: - Endurance
- Resistance
- Strength
- Explosive Strength
- Potentiation
- Training Recovery
(same as Active
Recovery) - Competition
Recovery (same as
Recovery Plus) - Pre-Warmup
Program - Muscle Relaxation
(same as Massage)
TENS:
-Pain relief TENS
(same as FM) | Similar
The two devices have two same
main Output Modes: NMES and
TENS, both modes NMES and
TENS of these two devices also
have same indications
respectively, although both
modes have different output
programs, these two modes have
almost the same parameter
range, and the NMES of the
proposed device can be adjusted
arbitrarily within the parameter
range, the TENS output
programs: Normal, Sweep,
Random, Alternation represents
different frequency adjustment
methods, same as Frequency
Modulation which is same with
the equivalent device. Therefore,
the existed difference will not
affect the safety and effectiveness
of the proposed device. | |
Basic Device Characteristics - Comparison with Predicate Device
6
7
8
Output Specifications – Comparison with Predicate Device
| Characteristic | Subject device
Present application
(Portable
Electro-Stimulation
Therapy Device, model
LGT-231) | Predicate device
(K170918, Compex Sport
Elite) | Discussion of difference |
|----------------|----------------------------------------------------------------------------------------------------------------|------------------------------------------------------|--------------------------|
| Manufacturer | Guangzhou Longest
Science & Technology
Co., Ltd | DJO, LLC | / |
9
| Waveform | NMES: | NMES: | Same |
|---|---|---|---|
| Symmetrical biphasic | -Endurance: | ||
| Symmetrical Biphasic | |||
| TENS: |
- Normal:
Balanced Symmetrical
biphasic | -Resistance:
Symmetrical Biphasic | |
| | - Random:
Balanced Symmetrical
biphasic | -Strength:
Symmetrical Biphasic | |
| | - Sweep:
Balanced Symmetrical
biphasic | -Explosive Strength:
Symmetrical Biphasic | |
| | - Alternation
Balanced Symmetrical
biphasic | -Potentiation:
Symmetrical Biphasic | |
| | | -Training Recovery (same
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 | |
| | | TENS:
-Pain relief TENS (same
as FM): Balanced,
asymetrical
Biphasic | |
| Shape (e.g., rectangular,
spike, rectified sinusoidal) | NMES:
Rectangular | NMES:
-Endurance:
Rectangular | Same |
| | TENS: - Normal:
Rectangular | -Resistance:
Rectangular | |
| | - Random:
Rectangular | -Strength:
Rectangular | |
| | - Sweep:
Rectangular | -Explosive Strength:
Rectangular | |
| | - Alternation
Rectangular | -Potentiation:
Rectangular | |
| | | -Training Recovery
(same as Active
Recovery):
Rectangular | |
| | | -Competition | |
10
| Recovery (same as | |||||||
|---|---|---|---|---|---|---|---|
| Recovery Plus): | |||||||
| Rectangular | |||||||
| -Pre-Warmup | |||||||
| Program: Rectangular | |||||||
| -Muscle Relaxation | |||||||
| (same as Massage): | |||||||
| Rectangular | |||||||
| TENS: | |||||||
| -Pain relief TENS | |||||||
| (same as FM): Rectangular | |||||||
| Maximum Output | |||||||
| Voltage (± 10%) | NMES: | ||||||
| 50 V @ 500 Ω | |||||||
| 115 V @ 2 kΩ | |||||||
| 125 V @ 10 kΩ | NMES: |
- Endurance:
60 V @ 500 Ω
165 V @ 2 kΩ
165 V @ 10 kΩ | Similar
The max output voltage of
proposed device is smaller than
predicate device, the predicate
device is safe and effective with
its output voltage range which
means the proposed device is
also safe and effective with its
output voltage, and at the
meantime, the proposed device
was also demonstrated electrical
safety by passing ANSI AAMI
ES60601-1 and IEC 60601-2-10
tests. Therefore, the difference
does not raise the issue of
product's safety and
effectiveness. | | | | |
| | TENS: - Normal:
50 V @ 500 Ω
115 V @ 2 kΩ
125 V @ 10 kΩ | - Resistance:
60 V @ 500 Ω
165 V @ 2 kΩ
165 V @ 10 kΩ | | | | | |
| | - Random:
50 V @ 500 Ω
115 V @ 2 kΩ
125 V @ 10 kΩ | - Strength:
60 V @ 500 Ω
165 V @ 2 kΩ
165 V @ 10 kΩ | | | | | |
| | - Sweep:
50 V @ 500 Ω
115 V @ 2 kΩ
125 V @ 10 kΩ | - Explosive Strength:
60 V @ 500 Ω
165 V @ 2 kΩ
165 V @ 10 kΩ | | | | | |
| | - Alternation
50 V @ 500 Ω
115 V @ 2 kΩ
125 V @ 10 kΩ | - Potentiation:
60 V @ 500 Ω
152 V @ 2 kΩ
136 V @ 10 kΩ | | | | | |
| | | - Training Recovery:
60 V @ 500 Ω
165 V @ 2 kΩ
165 V @ 10 kΩ | | | | | |
| | | - Competition Recovery:
60 V @ 500 Ω
165 V @ 2 kΩ
165 V @ 10 kΩ | | | | | |
| | | | | - Pre Warmup:
60 V @ 500 Ω | 60 V @ 500 Ω | | |
| | | 165 V @ 2 kΩ | | | | | |
| | | 165 V @ 10 kΩ | | | | | |
| | | - Muscle Relaxation: | | | | | |
| | | 60 V @ 500 Ω | | | | | |
| | | 165 V @ 2 kΩ | | | | | |
11
| 165 V @ 10 kΩ | |||
|---|---|---|---|
| TENS: | |||
| - Pain Relief TENS: | |||
| 60 V @ 500 Ω | |||
| 152 V @ 2 kΩ | |||
| 165 V @ 10 kΩ | |||
| Maximum Output | |||
| Current (± 10%) | NMES: | ||
| 100 mA @ 500 Ω | |||
| 58 mA @ 2 kΩ | NMES: |
- Endurance:
120 mA @ 500 Ω | Similar |
| | 13 mA @ 10 kΩ | 82 mA @ 2 kΩ | The output current of proposed
device is smaller than predicate |
| | | 16 mA @ 10 kΩ | device, the predicate device is |
| | TENS: - Normal: | - Resistance: | safe and effective with its output |
| | 100 mA @ 500 Ω | 120 mA @ 500 Ω | current range which means the |
| | 58 mA @ 2 kΩ | 82 mA @ 2 kΩ | proposed device is also safe and |
| | 13 mA @ 10 kΩ | 16 mA @ 10 kΩ | effective with its output current, |
| | | | and at the meantime, the |
| | - Random: | - Strength: | proposed device was also |
| | 100 mA @ 500 Ω | 120 mA @ 500 Ω | demonstrated electrical safety by |
| | 58 mA @ 2 kΩ | 82 mA @ 2 kΩ | passing ANSI AAMI ES60601-1 |
| | 13 mA @ 10 kΩ | 16 mA @ 10 kΩ | and IEC 60601-2-10 tests. |
| | | | Therefore, the difference does not |
| | - Sweep:
100 mA @ 500 Ω | - Explosive Strength:
120 mA @ 500 Ω | raise the issue of product's safety |
| | 58 mA @ 2 kΩ | 82 mA @ 2 kΩ | and effectiveness. |
| | 13 mA @ 10 kΩ | 16 mA @ 10 kΩ | |
| | | | |
| | - Alternation | - Potentiation: | |
| | 100 mA @ 500 Ω | 120 mA @ 500 Ω | |
| | 58 mA @ 2 kΩ | 82 mA @ 2 kΩ | |
| | 13 mA @ 10 kΩ | 16 mA @ 10 kΩ | |
| | | | |
| | | - Training Recovery: | |
| | | 120 mA @ 500 Ω | |
| | | 82 mA @ 2 kΩ
16 mA @ 10 kΩ | |
| | | | |
| | | - Competition Recovery: | |
| | | 120 mA @ 500 Ω | |
| | | 82 mA @ 2 kΩ | |
| | | 16 mA @ 10 kΩ | |
| | | | |
| | | - Pre Warmup | |
| | | 120 mA @ 500 Ω | |
| | | 82 mA @ 2 kΩ | |
| | | 16 mA @ 10 kΩ | |
| | | | |
| | | - Muscle Relaxation:
120 mA @ 500 Ω | |
| | | 82 mA @ 2 kΩ | |
| | | 16 mA @ 10 kΩ | |
| | | | |
| | | | |
| | | TENS: | |
| | | - Pain Relief TENS: | |
| | | 119[mA] peak@500 Ω | |
| | | 76[mA] peak@2 kΩ | |
12
| 12[mA] peak @10 kΩ | |||||||
|---|---|---|---|---|---|---|---|
| Pulse Width | NMES: | ||||||
| 50 to 400 µs |
TENS:
-
Normal:
50 to 400 µs -
Random:
50 to 400 µs -
Sweep:
50 to 400 µs -
Alternation
50 to 400 µs | NMES: -
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
200 to 400 [µs] -
Muscle Relaxation:
200 to 400 [µs]
TENS:
- Pain Relief TENS:
70 to 300[µs] (measured at 50% of positive pulse) | Similar
Risk arises with lager Pulse Width, since the largest Pulse Width of proposed device is same the predicate device, this tiny differences will not affect the safety and effectiveness of the proposed device | | | | |
| Frequency | | NMES:
1 to 120 Hz
TENS:
-
Normal:
1 to 120 Hz -
Random
1 to 120 Hz -
Sweep:
1 to 120 Hz -
Alternation
1 to 120 Hz | | NMES: -
Endurance:
10 Hz -
Resistance:
50 Hz -
Strength:
75 Hz -
Explosive Strength:
100 Hz -
Potentiation:
From 1 to 75 Hz -
Training Recovery:
10 Hz | - Competition Recovery: | Similar
The different frequency will finally cause different feelings, as for NMES mode, the frequency range of the proposed device is 1120Hz and the equivalent device is 1100Hz, both of them have similar frequency range and the parameter of the proposed device can be adjusted to the same with the proposed device, as for TENS mode, the frequency range of the proposed device is 1120Hz, and the equivalent device is 5122Hz, both of them have similar frequency range and are Frequency Modulation, therefore, these tiny difference | existed in Frequency between |
| | | 0.5 Hz | proposed device and predicate | | | | |
| | | - Pre Warmup: | device are acceptable. The | | | | |
| | | | difference will not raise the issue | | | | |
| | | | of product's safety and | | | | |
13
| 4 Hz | effectiveness. | |||
|---|---|---|---|---|
| - Muscle Relaxation: | ||||
| 1 Hz | ||||
| TENS: |
-
Pain Relief TENS:
5 to 122Hz | |
| For interferential modes
only: -
Beat Frequency [Hz] | | N/A | N/A | Same |
| For
multiphasic | Symmetrical
phases? | Yes | Yes | Same |
| waveforms
only | Phase
Duration
(include
units)
(state range,
if
applicable)
(both
phases, if
asymmetrical) | NMES:
Symmetrical, 50 -
400 µs | NMES: -
Endurance:
Symmetrical, 280 -
400 µs -
Resistance:
Symmetrical, 280 -
400 µs -
Strength:
Symmetrical, 280 -
400 µs -
Explosive Strength:
Symmetrical, 280 -
400 µs -
Potentiation:
Symmetrical, 280 -
400 µs -
Training Recovery:
Symmetrical, 280 -
400 µs -
Competition
Recovery:
Symmetrical, 280 -
400 µs -
Pre Warmup:
Symmetrical, 280 -
400 µs -
Muscle Relaxation:
Symmetrical, 280 -
400 µs
TENS:
-
Pain Relief TENS:
Symmetrical, 70 -
300 µs | Similar
Risk arises with lager Pulse
Width, since the largest Pulse
Width of proposed device is same
the predicate device, this tiny
differences will not affect the
safety and effectiveness of the
proposed device |
| | | TENS: -
Normal:
Symmetrical, 50 -
400 µs -
Random
Symmetrical, 50 -
400 µs -
Sweep:
Symmetrical, 50 -
400 µs -
Alternation
Symmetrical, 50 -
400 µs | | |
| Net Charge (µC/pulse) | | NMES: | NMES: | Same |
| | 0 μC @ 500Ω
TENS: -
Normal:
0 μC @ 500Ω | - Endurance:
0 [μC] @ 500Ω
Excitation pulse fully
Compensated | | |
| | - Random
0 μC @ 500Ω | - Resistance:
0 [μC] @ 500Ω
Excitation pulse fully
Compensated | | |
| | - Sweep:
0 μC @ 500Ω -
Alternation
0 μC @ 500Ω | - Strength:
0 [μC] @ 500Ω
Excitation pulse fully
Compensated | | |
| | | - Explosive Strength:
0 [μC] @ 500Ω
Excitation pulse fully
Compensated | | |
| | | - Potentiation:
0 [μC] @ 500Ω
Excitation pulse fully
Compensated | | |
| | | - Training Recovery:
0 [μC] @ 500Ω
Excitation pulse fully
Compensated | | |
| | | - Competition Recovery:
0 [μC] @ 500Ω
Excitation pulse fully
Compensated | | |
| | | - Pre Warmup
0 [μC] @ 500Ω
Excitation pulse fully
Compensated | | |
| | | - Muscle Relaxation:
0 [μC] @ 500Ω
Excitation pulse fully
Compensated | | |
| | | TENS: -
Pain Relief TENS:
0 [μC] @ 500Ω
Excitation pulse fully
compensated | | |
| Maximum Phase Charge
(μC) | NMES:48.24 μC @ 500Ω
TENS: 46.73 μC @ 500Ω | 48 (μC) @ 500Ω | Similar
The tiny difference existed in
Maximum Phase Charge between
proposed device and predicate
device are acceptable and the
proposed device was
demonstrated electrical safety by | |
| | | | | and IEC 60601-2-10 tests. The
difference does not raise the
issue of product's safety and
effectiveness. |
| Maximum Current Density,
(mA / cm², r.m.s.) | TENS: 1.94mA/cm² @
500Ω
NMES: 2.00mA/cm² @
500Ω | 4.8 (mA/cm²) @ 500Ω | | Similar
The proposed device has a
smaller maximum current density
than predicate device. The
proposed device was also
demonstrated electrical safety by
passing ANSI AAMI ES60601-1
and IEC 60601-2-10 tests. The
difference does not raise the
issue of product's safety and
effectiveness. |
| Maximum Average Power
Density (mW/cm²) | TENS: 30.15 mW/cm²
@500Ω
NMES: 32.28 mW/cm²
@500Ω | 27.6 (mW/cm²) @500Ω | | Similar
The tiny difference existed in
Maximum Average Power
between proposed device and
predicate device are acceptable
and the proposed device was
demonstrated electrical safety by
passing ANSI AAMI ES60601-1
and IEC 60601-2-10 tests. The
difference does not raise the
issue of product's safety and
effectiveness. |
| Burst
Mode
(i.e.,
pulse
trains) | Pulses per burst
Bursts per
second
Burst duration
(seconds)
Duty Cycle [Line
(b) x Line (c) | N/A, no burst mode | N/A, no burst mode | Same |
| ON Time (seconds) | | Depends on your own
settings, Once started, the
output is active until user
manually stops the unit | Depends on the
selected program | Same
Both device is depended on the
user's selection |
| OFF Time (seconds) | | Depends on your own
settings 1-60min | Depends on the
selected program | Same
Both device is depended on the
user's selection |
| Additional Features (if
applicable) | N/A | N/A | | Same |
14
15
8. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Non-clinical verification testing of the Portable Electro-Stimulation Therapy Device, model: LGT-231 included electrical, mechanical, and software tests to show the device meets its design specifications. Validation and performance testing validates that the device meets its user needs. Verification and validation test results established that the device meets its intended use, that it is as safe, as effective, and performs as well as the predicate devices, and that no new issues of safety and effectiveness were raised. The Portable Electro-Stimulation Therapy Device, model: LGT-231 was designed, verified, and validated according to the company's Design Control process and has been subjected to extensive safety and performance testing as shown in the test results provided in this submission.
16
Verification and Validation testing data demonstrate that the device meets all of its specifications including compliance with the following standards:
ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cvtotoxicitv
ISO 10993-10:2010 Biological evaluation of medical devices. Tests for irritation and skin sensitization
ANSI AAMI ES60601-1:2005+A1:2012 Medical electrical equipment. General requirements for basic safety and essential performance
ANSI AAMI ES60601-1-2:2014 Medical electrical equipment - part 1-2: general requirements for safety - collateral standard: electromagnetic compatibility - requirements and tests IEC 60601-2-10:2012 Medical Electrical equipment - Part 2-10: Particular requirements for the
safety of nerve and muscle stimulators
ANSI AAMI ES60601-1-11:2015 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.
9. Discussion of Clinical Tests Performed:
Longest determined that bench and non-clinical testing were sufficient to demonstrate that Portable Electro-Stimulation Therapy Device, model: LGT-231 is as safe and effective as the predicate device.
10. Conclusions
The electrical safety, EMC, biocompatibility, software verification and validation, basic unit characteristics, and output specifications information provided is sufficient to demonstrate substantial equivalence to the predicate device. As the Portable Electro-Stimulation Therapy Device, model: LGT-231 is nearly identical to the predicate device, differences in their characteristics do not raise any raise new questions regarding safety and effectiveness with identical indications for use and essentially identical technological characteristics, the Portable Electro-Stimulation Therapy Device, model: LGT-231 is substantially equivalent to the predicate device Compex Sport Elite.