(266 days)
Not Found
No
The description focuses on standard electrical stimulation modes (TENS and MCR) and a mobile app for basic control. There is no mention of adaptive algorithms, learning from patient data, or any other characteristics typically associated with AI/ML in medical devices. The performance studies also do not describe any AI/ML specific evaluations.
Yes
The device is indicated for the symptomatic relief of pain, which is a therapeutic purpose. It uses transcutaneous electrical stimulation (TENS) and Microcurrent (MCR) to modify pain perception.
No
This device is a therapy device (electro-stimulation) used for symptomatic relief of pain, not for diagnosing medical conditions.
No
The device description explicitly states the system is made up of a mobile app, a main unit, and electrodes (knee brace and self-adhesive electrode). This includes 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-235, is a therapeutic device that applies electrical stimulation to the skin to alleviate pain. It does not analyze any biological samples.
- Intended Use: The intended use is for symptomatic relief of pain, not for diagnosing or monitoring a condition through the analysis of in vitro samples.
- Device Description: The description clearly outlines the device's function as a stimulator that sends electrical current through electrodes applied to the skin.
Therefore, the device's purpose and mechanism of action fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Portable Electro-Stimulation Therapy Device, model LGT-235 is indicated for the Symptomatic relief of chronic intractable pain, Post-traumatic pain and Post-surgical pain of the arms and legs.
Product codes (comma separated list FDA assigned to the subject device)
GZJ
Device Description
The Portable Electro-Stimulation Therapy Device, model LGT-235 is a stimulator which sends gentle electrical current to underlying nerves via electrodes (Knee brace or self-adhesive electrode) applied on the skin with two operational modes and powered by rechargeable lithium battery; the device system is made up of mobile app MStim Arth, main unit and electrodes (Knee brace and self-adhesive electrode).
The Mobile App MStim Arth provides access to treatment controls for Portable Electro-Stimulation Therapy Device from a compatible mobile device for selecting a pre-programmed output mode and treatment time.
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-235 employs are transcutaneous electrical stimulation (TENS) and Microcurrent (MCR).
TENS and MCR are both specifically targets the sensory nerves, which are responsible for sending pain signals to the brain. TENS and MCR use tiny electrical impulses sent through the skin to nerves to modify the pain perception. TENS and MCR do not cure any physiological problem; it only helps control the pain, this activates the underlying sensory nerves. Knee brace is placed on the leg or arm close to the area of pain.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Arm and legs
Indicated Patient Age Range
adults
Intended User / Care Setting
home
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-235 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-235 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. 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 cytotoxicityISO 10993-10:2010 Biological evaluation of medical devices. Tests for irritation and skin sensitization
-
- ANSI AAMI ES60601-1:2005/(R) 2012 and A1:2012 Medical electrical equipment. General requirements for basic safety and essential performance
-
- IEC 60601-1-2:2014 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
-
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 26, 2018
Guangzhou Longest Science & Technology Co., Ltd. % You Yijie Manager Oimmig Medical Consulting Service Co., Ltd RM.1711, Building K, NO.101 Science Ave International Creative Valley Guangzhou, 510663 Cn
Re: K182108
Trade/Device Name: Portable Electro-Stimulation Therapy Device Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: March 29, 2019 Received: March 29, 2019
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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Pamela D. Scott -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182108
Device Name Portable Electro-Stimulation Therapy Device
Indications for Use (Describe)
Portable Electro-Stimulation Therapy Device, model LGT-235 is indicated for the Symptomatic relief of chronic intractable pain, Post-traumatic pain and Post-surgical pain of the arms and legs.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(K) Summary
Date: April 24, 2019
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: Xiaobinq 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: qzlongest@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@gimmiq-med.com
2. Device Information
Type of 510(K) submission: Traditional Trade Name: Portable Electro-Stimulation Therapy Device Model: LGT-235 Regulation name: Transcutaneous electrical nerve stimulator for pain relief. Review panel: Neurology Product code: GZJ Requlation Class: II Regulation Number: 21 CFR 882.5890
3. Predicate Device Information
510(k) submitter/holder: Mettler Electronics Corp. 510(K) Number: K111482 Regulation Class: 2 Device: Sonicator Plus 920 Sonicator Plus 920, Model ME 920 Trade name:
4
4. Device description
The Portable Electro-Stimulation Therapy Device, model LGT-235 is a stimulator which sends gentle electrical current to underlying nerves via electrodes (Knee brace or self-adhesive electrode) applied on the skin with two operational modes and powered by rechargeable lithium battery; the device system is made up of mobile app MStim Arth, main unit and electrodes (Knee brace and self-adhesive electrode).
The Mobile App MStim Arth provides access to treatment controls for Portable Electro-Stimulation Therapy Device from a compatible mobile device for selecting a pre-programmed output mode and treatment time.
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-235 employs are transcutaneous electrical stimulation (TENS) and Microcurrent (MCR).
TENS and MCR are both specifically targets the sensory nerves, which are responsible for sending pain signals to the brain. TENS and MCR use tiny electrical impulses sent through the skin to nerves to modify the pain perception. TENS and MCR do not cure any physiological problem; it only helps control the pain, this activates the underlying sensory nerves. Knee brace is placed on the leg or arm close to the area of pain.
5. Principle of operation:
The Portable Electro-Stimulation Therapy Device, model LGT-235 sends gentle electrical current to underlying nerves and muscle group via electrodes (Knee brace or self-adhesive electrode) applied on the skin and powered by rechargeable lithium battery. When used in TENS or MCR mode, it 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 pain perception and finally helps control the pain.
6. Indications for Use
Portable Electro-Stimulation Therapy Device, model LGT-235 is indicated for the Symptomatic relief of chronic intractable pain, Post-traumatic pain and Post-surgical pain of the arms and legs..
7. Summary of technological characteristics of device compared to the predicate devices (K111482)
| Characteristic | Subject device | Predicate device | Discussion of difference | |
|---|---|---|---|---|
| Present application | ||||
| (Portable | ||||
| Electro-Stimulation | ||||
| Therapy Device, model | (K111482, Sonicator | |||
| Plus 920, Model ME | ||||
| 920 (TENS and | ||||
| Microurrent mode)) | ||||
| LGT-235) | ||||
| Classification | 21 CFR 882.5890 | 21 CFR 890.5890 | Same | |
| Product Code | GZJ | GZJ | Same | |
| FDA Class | 2 | 2 | Same | |
| Intended Use | Symptomatic relief of | |||
| chronic intractable pain |
- Post-traumatic pain
- Post-surgical pain | Symptomatic relief of
chronic intractable pain - Post-traumatic pain
- Post-surgical pain | Same | |
| Principle of operation | sends gentle electrical
current to muscle group
via electrodes applied
on the skin | sends gentle electrical
current to muscle group
via electrodes applied
on the skin | Same | |
| target population | adults | adults | Same | |
| anatomical site | Arm and legs | Arm and legs | Same | |
| Material of Patient
contact components | Electrodes:
Knee brace: OK cloth +
SBR + dacron
Conductive fabric:
Silver wire + nylon
Self-adhesive electrode:
conductive hydrogel | Electrode: conductive
hydrogel | Different
Knee brace was
demonstrated
biocompability safety by
passing ISO 10993-5 and
ISO 10993-10 tests. The
difference does not raise
the issue of product's
safety and effectiveness. | |
| where used | home | home | Same | |
| Design | Handheld | Desk type | Different
This difference existed will
not affect the safety and
effectiveness of the
proposed device | |
| Power Source | Rechargeable lithium
battery 3.7V | AC line | Different
The proposed device was
demonstrated electrical
safety by passing ANSI
AAMI ES60601-1. The
difference does not raise
the issue of product's
safety and effectiveness. | |
| Method of line
current isolation | N/A (3.7V rechargeable
lithium battery operated
device) | Double isolation | Different
This difference existed will
not affect the safety and
effectiveness of the
proposed device. | |
| Patient
Leakage | Normal
condition | 50μΑ | demonstrated electrical
safety by meet the
requirement of chapter
8.7.4.7 of ANSI AAMI
ES60601-1. The
difference does not raise
the issue of product's
safety and effectiveness. |
| Number
of Output
Channels | Number | One | two | Different
This will not affect the
safety and effectiveness
of the proposed device |
| | Synchronous
s or
Alternating? | Synchronous | Synchronous | Same |
| Number of Output
Modes | | two (TENS + MCR) | two (TENS + MCR
modes) | Same |
| Regulated Current or
Regulated Voltage? | | Current | Current | Same |
| | Software/Firmware/Micr
oprocessor 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" button | Same |
| | User Override Control? | No, On/Off | No, On/Off, Hold or Stop | Same |
| Indicator
Display | On/Off
Status? | Yes | Yes | Same |
| | Low Battery? | Yes | N/A | Different
This difference existed will
not affect the safety and
effectiveness of the
proposed device |
| | 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) | 160 minutes | 060 minutes | Same |
| ANSI AAMI ES60601-1 | Yes | Yes | Same | |
| IEC 60601-1-2 | Yes | Yes | Same | |
| IEC 60601-2-10 | Yes | Yes | Same | |
| Weight | main unit: 120g
Charging case: 150g | 11(lbs.) | Different
The Weight will not affect
the safety and
effectiveness of the
proposed device | |
| Dimensions
(W x H x D) | 59mm (W) × 59mm (L) ×
22mm (H) (mm) | 4.9 x 13.6 x10.5(in.) | Different
The dimensions will not
affect the safety and
effectiveness of the
proposed device | |
| Operating
condition | Temperature: 5 to 40°C;
Rel. humidity: ≤80%;
Atmosphere Pressure:
86.0 to 106.0kPa. | Temperature of use from
10°C to 40°C
Max. relative humidity
from 30% to 75%
Atmospheric pressure
from 700 hPa to1060 hPa | Similar
The operating condition of
subject device has passed
the safety test, and the
Instructions for Use
provides the operating
condition, so the
difference between the
operating conditions of
subject device and
predicate device will not
affect the safety and
effectiveness of subject
device | |
Basic Device Characteristics - Comparison with Predicate Device
5
6
7
Output Specifications – Comparison with Predicate Device
| Characteristic | Subject device
Present application
(Portable
Electro-Stimulation
Therapy Device, model
LGT-235) | Predicate device
(K111482, Sonicator
Plus 920, Model ME
920 (TENS and
Microurrent mode)) | Discussion of difference | |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Waveform | Symmetrical biphasic | Symmetrical Biphasic | Same | |
| Maximum Output
Voltage (± 20%) | TENS:
50V @ 500 Ω
115 V @ 2 kΩ
125 V @ 10 kΩ
MCR:
0.45 V@ 500 Ω
1.8 V@ 2 kΩ
7.4 V @ 10 kΩ | TENS:
50 V @ 500 Ω
115 V @ 2 kΩ
125 V @ 10 kΩ
MCR:
0.37 V @ 500 Ω
1.5 V @ 2 kΩ
7.4 V @ 10 kΩ | Similar
The error existed in MCR
mode between proposed
device and predicate
device are acceptable.
The difference does not
raise the issue of
product's safety and
effectiveness. | |
| Maximum Output | TENS: | TENS: | | |
| Current (± 20%) | | 100 mA@ 500 Ω
58 mA@ 2 kΩ
13 mA@ 10 kΩ
MCR:
0.92 mA@ 500 Ω
0.90 mA@ 2 kΩ
0.74 mA@ 10 kΩ | 100 mA@ 500 Ω
58 mA@ 2 kΩ
13 mA@ 10 kΩ
MCR:
0.74 mA@ 500 Ω
0.75 mA@ 2 kΩ
0.74 mA@ 10 kΩ | The error existed in MCR
mode between proposed
device and predicate
device are acceptable.
The difference does not
raise the issue of
product's safety and
effectiveness. |
| Pulse Width | | TENS: 50 to 500 μs | TENS: 100 ~ 600us | Similar |
| | | MCR: 4.16 ms ~ 0.5s | MCR: 1.25ms ~ 1.67s | The predicate device is
safe and effective in pulse
width range 100 ~ 600us
for TENS mode and
1.25ms ~ 1.67s for MCR
mode, since the pulse
width range of proposed
device are in the range of
predicate device, the
proposed device is also
safe and effective with its
pulse width, therefore, the
difference does not raise
the issue of product's
safety and effectiveness. |
| Frequency | | TENS: 1 ~ 120 Hz | TENS: 0.5 ~ 250 Hz | Similar |
| | | MCR: 1 ~ 120 Hz | MCR: 0.3 ~ 400 Hz | The frequency range of
predicate device is
overriding the range of
proposed device, since
the predicate device is
safe and effective,
therefore the proposed
device is also safe and
effective, the difference
does not raise the issue of
product's safety and
effectiveness. |
| Maximum intensity | | 100mA | 100 mA | Same |
| For
multiphasic | Symmetrical
phases? | Yes | Yes | Same |
| waveforms
only | Phase
Duration
(include
units)
(state
range, if
applicable
) (both
phases, if
asymmetric
al) | TENS: 50 to 500 µs
MCR: 4.16 ms ~ 0.5s | TENS: 100 ~ 600us
MCR: 1.25ms ~ 1.67s | Similar |
| | | | | The predicate device is
safe and effective in pulse
width range 100 ~ 600us
for TENS mode and
1.25ms ~ 1.67s for MCR
mode, since the pulse
width range of proposed
device are in the range of
predicate device, the
proposed device is also
safe and effective with its
pulse width, therefore,
difference existed does
not raise the issue of
product's safety and
effectiveness. |
| Stimulating surface area
of electrode (minimum) | | 2500mm² (50mm,
square) | 2015.80mm² (50.8mm
diameter, round) | Similar
The smaller of the surface
area the higher risk is, the
difference does not raise
the issue of product's
safety and effectiveness. |
| Net Charge (µC/pulse) | | TENS:0µC @ 500Ω
MCR: 0µC@ 500Ω | 0 µC @ 500Ω | Same. |
| Maximum Phase
Charge (µC) | | TENS: 48 (µC) @ 500Ω
MCR: 34 (µC) @ 500Ω | TENS: 60 (µC) @ 500Ω
MCR: 75 (µC) @ 500Ω | Similar
The Maximum Phase
Charge of predicate
device is overriding the
proposed device, since
the predicate device is
safe and effective,
therefore the proposed
device is also safe and
effective, difference
existed does not raise the
issue of product's safety
and effectiveness. |
| Maximum Current
Density,
(mA / cm², r.m.s.) | | TENS: 0.81mA/cm2 @
500Ω
MCR: 0.036mA/cm2@
500Ω | TENS: 1.97 (mA/cm2)
@ 500Ω
MCR: 0.026mA/cm2 @
500Ω | Similar
For TENS mode, the
maximum current density
of proposed device is
overriding the proposed
device which means the
proposed device is safe
and effective. As for mode
MCR, the maximum
current density of
proposed device is little
bigger than predicate
device, however the
proposed device was
demonstrated safety by |
| | | | IEC 60601-2-10. The
difference does not raise
the issue of product's
safety and effectiveness. | |
| Maximum Power
Density (W/cm²) | TENS: 8.26 mW/cm²
@ 500Ω
MCR: 0.016 W/cm²
@ 500Ω | TENS: 39 mW/cm²
@ 500Ω
MCR: 0.007 mW/cm²
@ 500Ω | Similar
For TENS mode, the
maximum power density
of proposed device is
overriding the proposed
device which means the
proposed device is safe
and effective. As for mode
MCR, the maximum
power density of proposed
device is bigger than
predicate device but far
less than 0.25 W/cm²
required by Guidance
Document for Powered
Muscle Stimulator (June
9, 1999), the difference
does not raise the issue of
product's safety and
effectiveness. | |
8
9
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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-235 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-235 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. 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 cytotoxicityISO 10993-10:2010 Biological evaluation of medical devices. Tests for irritation and skin sensitization
-
- ANSI AAMI ES60601-1:2005/(R) 2012 and A1:2012 Medical electrical equipment. General requirements for basic safety and essential performance
-
- IEC 60601-1-2:2014 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
-
- 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.
11
9. 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-235 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-235 is substantially equivalent to the predicate device Sonicator Plus 920, Model ME 920 (TENS and MCR mode).