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

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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 {2}------------------------------------------------ # 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: 1. Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities; 2. 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary 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<br>Co., Ltd. | |---------|----------|-----------------------------------------| |---------|----------|-----------------------------------------| {4}------------------------------------------------ | Device Name | Compex Wireless USA | TENS and Muscle Stimulator<br>(Model AS8012) | |----------------------|---------------------|----------------------------------------------| | 510(k) Number | K170903 | K200727 | | Product Code | NGX, NUH, NYN | NUH, NGX | | Regulation<br>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; 2) 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 - 2) IEC 60601-1:2005: Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance - 3) 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}------------------------------------------------ - 4) IEC 60601-2-10: 2012: Medical Electrical Equipment - Part 2: Particular requirements for the basic safety and essential performance of neve and muscle stimulators. - 5) 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 - 7) Biological evaluation of medical device Part 10: Tests forirritation and skin sensitization (ISO 10993- 10: 2010) - 8) 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<br>Model | Portable Electro-Stimulation<br>Therapy Device, Model: LGT-<br>232(US) | Compex Wireless USA | TENS and Muscle Stimulator<br>(Model AS8012) | N/A | | | Manufacturer | Guangzhou Longest Science &<br>Technology CO., Ltd. | DJO, LLC | Shenzhen As-Tec Technology<br>Co., Ltd. | N/A | | | Prescription/OTC | OTC | OTC | OTC | Same | | | Indications for use | The Portable Electro-Stimulation<br>Therapy Device, model LGT-<br>232(US) is used to: Stimulate<br>healthy muscles in order to<br>improve or facilitate muscle<br>performance. It is to be used by<br>adults only.<br>Portable Electro-Stimulation<br>Therapy Device, model LGT-<br>232(US) in TENS mode is used<br>for:<br>1. Temporary relief of pain<br>associated with sore and aching<br>muscles due to strain from | The Compex Wireless USA is an<br>Over-The-Counter device intended<br>to stimulate healthy muscles in order<br>to improve or facilitate muscle<br>performance. It is to be used by<br>adults only.<br>The Compex Wireless USA is not<br>intended for adjunctive therapy in the<br>treatment of medical diseases and<br>conditions of any kind. None of the<br>Compex Wireless USA stimulation<br>programs are designed for injured or<br>disease afflicted muscles.<br>Its use on such muscles is<br>contraindicated. The work imposed<br>on the muscles by the Compex | TENS(Transcutaneous Electric<br>Nerve Stimulation):<br>To be used for temporary relief<br>of pain associated with sore<br>and aching muscles in the<br>shoulder, waist, back, upper<br>extremities (arm), and lower<br>extremities (leg) due to strain<br>from exercise or normal<br>household work activities.<br>PMS(Powered Muscle<br>Stimulation):<br>It is intended to be used to<br>stimulate healthy muscles in | Different, but does<br>not raise different<br>questions of safety and<br>effectiveness. | | | Characteristic | New Device | Predicate Device I | Predicate Device II | Comparison | | | | exercise or normal household<br>and work activities;<br><br>2. The symptomatic relief<br>and management of chronic,<br>intractable pain and reliefof pain<br>associated with arthritis. | Wireless USA programs is definitely<br>not suitable for rehabilitation and<br>physiotherapy. The Compex<br>Wireless USA electrical impulses<br>allow the triggering of action<br>potentials on motoneurones of motor<br>nerves (excitations). These<br>excitations of motoneurones are<br>transmitted to the muscle fibers via<br>the motor endplate where they<br>generate mechanical muscle fiber<br>responses that correspond to<br>muscle work. Depending on the<br>parameters of the electrical<br>impulses (pulse frequency, duration<br>of contraction, duration of rest, total<br>session duration), different types of<br>muscle work can be imposed on the<br>stimulated muscles. The Compex<br>Wireless USA may therefore be<br>considered a technique of muscle<br>training.<br><br>The Compex Wireless USA TENS is<br>used for:<br><br>• temporary relief of pain associated<br>with sore and aching muscles due to | order to improve and facilitate<br>muscle performance. | | | | Characteristic | New Device | Predicate Device I | Predicate Device II | Comparison | | | | | strain from exercise or normal<br>household and work activities.<br>• the symptomatic relief and<br>management of chronic, intractable<br>pain and relief of pain associated<br>with arthritis. | | | | | Product Code | NGX, NUH, NYN | NGX, NUH, NYN | NUH, NGX | Same | | | Regulation Number | 890.5850 | 890.5850 | 890.5850 | Same | | | Power Sources | Adapter model: HYI11-005<br>Adapter supply voltage: AC100-<br>240V, 50/60Hz<br>Adapter output: DC 5V, 2A.<br>Battery: 3.7V, 500mAh, lithium<br>battery. | Remote: Lithium Polymer (LiPo)<br>rechargeable 3.7[V] / ≥1500[mAh<br>Stimulation Modules:<br>Lithium Polymer (LiPo)<br>rechargeable 3.7[V] / ≥ 450[mAh] | DC 3.7V lithium battery | Different, but does<br>not raise different<br>questions of safety and<br>effectiveness.<br>See Note 1 | | | Method of Line<br>Current Isolation | N/A (battery operated<br>device) | N/A (battery operated<br>device) | Type BF | Different, but does<br>not raise different questions<br>of safety and effectiveness.<br>See Note 1 | | | Characteristic | New Device | Predicate Device I | Predicate Device II | Comparison | | | Number of Modes<br>for Micro current<br>stimulation | Two (NMES/TENS) | Two (NMES/TENS) | Two (TENS/PMS) | Only mode designation<br>difference between PMS and<br>NMES, but the function and<br>design for PMS is same with<br>the mode of NMES. It does<br>not raise different questions<br>of safety and effectiveness. | | | Number of<br>Channels for Micro<br>current stimulation | 1 | 4 | 2 | Different, but does not<br>raise different questions of<br>safety and effectiveness.<br>See Note 1 | | | Synchronous or<br>Alternating | Synchronous | Synchronous, but never 2 channels<br>activated at the same<br>time | Alternating | Different, but does<br>not raise different<br>questions of safety and<br>effectiveness.<br>See Note 1 | | | Regulated Current<br>or Regulated<br>Voltage | Regulated Current | Regulated Current | Voltage control | Different, but does<br>not raise different questions<br>of safety and effectiveness.<br>See Note 1 | | | Software/Firmware<br>/Microproc es sor<br>control | Yes | Yes | Yes | Same | | | Automatic<br>Overload Trip | Yes | Yes | No | Different, but does<br>not raise different questions<br>of safety and effectiveness.<br>See Note 2 | | | Automatic No-load<br>Trip | Yes. | Yes | Yes | Same | | | Characteristic | New Device | Predicate Device I | Predicate Device II | Comparison | | | Automatic Shut Off | Yes. | "On/Off" switch | Yes | Different, but does<br>not raise different<br>questions ofsafety and<br>effectiveness.<br>See Note 2. | | | Patient Override<br>Control | Yes | Yes, push on On/Off button<br>directly pause the program | Yes | Different, but does<br>not raise different<br>questions ofsafety and<br>effectiveness.<br>See Note 2. | | | Indicator<br>Display | On/Off<br>Status | Yes | Yes | Same | | | | Low Battery | Yes | Yes | Yes | Same | | | Voltage/Current Level | Yes | Yes | Yes | Same | | | Timer Range…