(94 days)
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.
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.
The provided text is a 510(k) summary for a medical device (Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)). It outlines the device's characteristics and compares them to predicate devices to establish substantial equivalence. However, this document does not describe a study involving human subjects or artificial intelligence (AI) performance validation.
The "Test Summary" section [5] refers to lab bench testing according to various safety and performance standards (e.g., IEC 60601-1, IEC 60601-2-10, ISO 10993-10, ISO 10993-5). This type of testing evaluates the device's electrical safety, electromagnetic compatibility, and biocompatibility, as well as its physical output parameters (voltage, current, frequency, pulse width). It does not involve "acceptance criteria" related to diagnostic accuracy, a human-in-the-loop study, or AI performance, as typically seen in submissions for AI/ML-driven medical devices.
Therefore, because the provided text is a 510(k) summary for an electro-stimulation therapy device that relies on established safety and performance standards for comparison to predicates, and not a study validating AI or diagnostic performance, I cannot extract the information required to populate the fields related to acceptance criteria, study design, expert involvement, or AI performance.
The document focuses on demonstrating that the new device is functionally and safely comparable to existing, legally marketed predicate devices, primarily through engineering specifications and adherence to relevant international standards.
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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.
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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 TechnologyCo., Ltd. |
|---|---|---|
| --------- | ---------- | ----------------------------------------- |
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| Device Name | Compex Wireless USA | TENS and Muscle Stimulator(Model AS8012) |
|---|---|---|
| 510(k) Number | K170903 | K200727 |
| Product Code | NGX, NUH, NYN | NUH, NGX |
| RegulationNumber | 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
-
- 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
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-
- 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 -6) 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)
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.
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| Characteristic | New Device | Predicate Device I | Predicate Device II | Comparison | |
|---|---|---|---|---|---|
| 510 (K) Number | (To Be Assigned) | K170903 | K200727 | N/A | |
| Device Name andModel | Portable Electro-StimulationTherapy 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 TechnologyCo., Ltd. | N/A | |
| Prescription/OTC | OTC | OTC | OTC | Same | |
| Indications for use | The Portable Electro-StimulationTherapy Device, model LGT-232(US) is used to: Stimulatehealthy muscles in order toimprove or facilitate muscleperformance. It is to be used byadults only.Portable Electro-StimulationTherapy Device, model LGT-232(US) in TENS mode is usedfor:1. Temporary relief of painassociated with sore and achingmuscles due to strain from | The Compex Wireless USA is anOver-The-Counter device intendedto stimulate healthy muscles in orderto improve or facilitate muscleperformance. It is to be used byadults only.The Compex Wireless USA is notintended for adjunctive therapy in thetreatment of medical diseases andconditions of any kind. None of theCompex Wireless USA stimulationprograms are designed for injured ordisease afflicted muscles.Its use on such muscles iscontraindicated. The work imposedon the muscles by the Compex | TENS(Transcutaneous ElectricNerve Stimulation):To be used for temporary reliefof pain associated with soreand aching muscles in theshoulder, waist, back, upperextremities (arm), and lowerextremities (leg) due to strainfrom exercise or normalhousehold work activities.PMS(Powered MuscleStimulation):It is intended to be used tostimulate healthy muscles in | Different, but doesnot raise differentquestions of safety andeffectiveness. | |
| Characteristic | New Device | Predicate Device I | Predicate Device II | Comparison | |
| exercise or normal householdand work activities;2. The symptomatic reliefand management of chronic,intractable pain and reliefof painassociated with arthritis. | Wireless USA programs is definitelynot suitable for rehabilitation andphysiotherapy. The CompexWireless USA electrical impulsesallow the triggering of actionpotentials on motoneurones of motornerves (excitations). Theseexcitations of motoneurones aretransmitted to the muscle fibers viathe motor endplate where theygenerate mechanical muscle fiberresponses that correspond tomuscle work. Depending on theparameters of the electricalimpulses (pulse frequency, durationof contraction, duration of rest, totalsession duration), different types ofmuscle work can be imposed on thestimulated muscles. The CompexWireless USA may therefore beconsidered a technique of muscletraining.The Compex Wireless USA TENS isused for:• temporary relief of pain associatedwith sore and aching muscles due to | order to improve and facilitatemuscle performance. | |||
| Characteristic | New Device | Predicate Device I | Predicate Device II | Comparison | |
| strain from exercise or normalhousehold and work activities.• the symptomatic relief andmanagement of chronic, intractablepain and relief of pain associatedwith 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: HYI11-005Adapter supply voltage: AC100-240V, 50/60HzAdapter output: DC 5V, 2A.Battery: 3.7V, 500mAh, lithiumbattery. | Remote: Lithium Polymer (LiPo)rechargeable 3.7[V] / ≥1500[mAhStimulation Modules:Lithium Polymer (LiPo)rechargeable 3.7[V] / ≥ 450[mAh] | DC 3.7V lithium battery | Different, but doesnot raise differentquestions of safety andeffectiveness.See Note 1 | |
| Method of LineCurrent Isolation | N/A (battery operateddevice) | N/A (battery operateddevice) | Type BF | Different, but doesnot raise different questionsof safety and effectiveness.See Note 1 | |
| Characteristic | New Device | Predicate Device I | Predicate Device II | Comparison | |
| Number of Modesfor Micro currentstimulation | Two (NMES/TENS) | Two (NMES/TENS) | Two (TENS/PMS) | Only mode designationdifference between PMS andNMES, but the function anddesign for PMS is same withthe mode of NMES. It doesnot raise different questionsof safety and effectiveness. | |
| Number ofChannels for Microcurrent stimulation | 1 | 4 | 2 | Different, but does notraise different questions ofsafety and effectiveness.See Note 1 | |
| Synchronous orAlternating | Synchronous | Synchronous, but never 2 channelsactivated at the sametime | Alternating | Different, but doesnot raise differentquestions of safety andeffectiveness.See Note 1 | |
| Regulated Currentor RegulatedVoltage | Regulated Current | Regulated Current | Voltage control | Different, but doesnot raise different questionsof safety and effectiveness.See Note 1 | |
| Software/Firmware/Microproc es sorcontrol | Yes | Yes | Yes | Same | |
| AutomaticOverload Trip | Yes | Yes | No | Different, but doesnot raise different questionsof safety and effectiveness.See Note 2 | |
| Automatic No-loadTrip | Yes. | Yes | Yes | Same | |
| Characteristic | New Device | Predicate Device I | Predicate Device II | Comparison | |
| Automatic Shut Off | Yes. | "On/Off" switch | Yes | Different, but doesnot raise differentquestions ofsafety andeffectiveness.See Note 2. | |
| Patient OverrideControl | Yes | Yes, push on On/Off buttondirectly pause the program | Yes | Different, but doesnot raise differentquestions ofsafety andeffectiveness.See Note 2. | |
| IndicatorDisplay | On/OffStatus | Yes | Yes | Same | |
| Low Battery | Yes | Yes | Yes | Same | |
| Voltage/Current Level | Yes | Yes | Yes | Same | |
| Timer Range | a) Treatment time: 9min-49min,b) Timer tolerance: ±2%;c) When finish, the device canstop output and prompt | Not publicly available | 10 ~ 60 minutes, 10min/step | Different, but doesnot raise differentquestions of safety andeffectiveness.See Note 3. | |
| Characteristic | New Device | Predicate Device I | Predicate Device II | Comparison | |
| Console weight | Main unit 60g;Charging case:150g | - Remote: 110[g]- StimulationModule:2x60 [g]- Docking Station 800[g] | 72g | Different, but doesnot raise differentquestions of safety andeffectiveness.See Note 8. | |
| Housing Materialsand Construction | ABS | not publicly available | ABS+Stainless iron | Different, but doesnot raise differentquestions of safetyand 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 doesnot raise differentquestions of safety andeffectiveness.See Note 4. | |
| Characteristic | New Device | Predicate Device I | Predicate Device II | Comparison | |
| as Active Recovery):Symmetrical Biphasic-Competition Recovery (same asRecovery Plus):Symmetrical Biphasic-Pre-Warmup Program:Symmetrical Biphasic-Muscle Relaxation (sameas Massage):Symmetrical Biphasic-Pain relief TENS (sameas 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 onRecovery:Rectangul ar | |||||
| -Pre-W arm up:Rectangular | |||||
| -Muscle Relaxation:Rectangular | |||||
| -Pain relief TENS (sameas FM): | |||||
| Characteristic | New Device | Predicate Device I | Predicate Device II | Comparison | |
| Maximum OutputVoltage | For P1:46.23V ±10% @ 500Ω ;102.9V ±10% @2ΚΩ;108.75V±10% @ 10ΚΩ | Endurance:60 V ±10% @ 500Ω165 V±10% @ 2 ΚΩ165 V±10% @ 10 ΚΩ | For TENS mode and PMSmode:49.6V±20% @500Ω;90V±20% @2kΩ;120V±20% @10kΩ | Different, but doesnot raise differentquestions of safety andeffectiveness.See Note 5. Remarks:Compared withpredicate device I:P1 is compared toEndurance; | |
| For P2:45.98V±10% @ 500Ω104.45V ±10% @ 2ΚΩ;108.75V±10% @ 10ΚΩ | Resistance:60 V ±10% @ 500Ω165 V ±10% @ 2 ΚΩ165 V ±10% @ 10 ΚΩ | P2 is compared toResistance mode; | |||
| For P3:45.76 V ±10% @ 500Ω;103V ±10% @ 2ΚΩ;108.7V±10% @ 10ΚΩ | Strength:60 V±10% @ 500Ω165 V±10% @ 2 ΚΩ165 V ±10% @ 10 ΚΩ | P3 is compared to Strengthmode; | |||
| For P4:45.76 V ±10% @ 500Ω; | Explosive Strength:60 V±10% @ 500Ω | P4 is compared toExplosive Strength mode;P5 is compared toPotentiation mode;P6 is compared toTraining Recovery;P7 is compared to PainRelief TENS mode | |||
| Characteristic | New Device | Predicate Device I | Predicate Device II | Comparison | |
| 103V ±10% @ 2KΩ; | 165 V ±10% @ 2 kΩ | Compared with predicatedevice II:P1 to P6 is comparedto PMS mode;P7 is compared toTENS 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% @ 500Ω165 V±10% @ 2 kΩ165 V±10% @ 10 kΩPre 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 kΩ165 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 OutputCurrent | For P1: | Endurance: | For TENS mode and PMSmode:99.2mA±20% @500Ω;45mA±20% @2kΩ;12mA±20% @10kΩ | Different, but doesnot raise differentquestions ofsafety andeffectiveness.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 withpredicate device I:P1 is compared toEndurance;P2 is compared toResistance mode;P3 is compared to Strengthmode;P4 is compared toExplosive Strength mode;P5 is compared toPotentiation mode;P6 is compared toTraining Recovery;P7 is compared to PainRelief TENS mode | |||||
| For P2:92mA±10% @ 500Ω;52mA ±10% @ 2KΩ;11mA±10% @ 10KΩ | Resistance:116 mA±10% @ 500Ω80 mA ±10% @ 2 kΩ17 mA ±10% @ 10 kΩ | ||||
| For P3:92mA±10% @ 500Ω;52mA ±10% @ 2KΩ;11mA±10% @ 10KΩ | Strength:113 mA ±10% @ 500Ω80 mA ±10% @ 2 kΩ15 mA ±10% @ 10 kΩ | ||||
| For P4:92mA±10% @ 500Ω;52mA ±10% @ 2KΩ;11mA±10% @ 10KΩ | Explosive Strength:81 mA±10% @ 500Ω81 mA±10% @ 2 kΩ15 mA ±10% @ 10 kΩ | ||||
| Characteristic | New Device | Predicate Device I | Predicate Device II | Comparison | |
| For P5:92mA±10% @ 500Ω;52mA ±10% @ 2KΩ;11mA±10% @ 10KΩFor P6:92mA±10% @ 500Ω;52mA±10% @ 2KΩ;11mA±10% @ 10KΩ | Potentiation:117 mA ±10% @ 500Ω80 mA±10% @ 2 kΩ16 mA±10% @ 10 kΩTraining Recovery:116 mA±10% @ 500Ω81mA±10% @ 2 kΩ16 mA±10% @ 10 kΩCompetition Recovery:116 mA ±10% @ 500Ω81 mA±10% @ 2 kΩ16 mA ±10% @ 10 kΩ | Compared withpredicate device II:P1 to P6 is compared toPMS mode;P7 is compared toTENS mode; | |||
| Characteristic | New Device | Predicate Device I | Predicate Device II | Comparison | |
| Pre Warmup | |||||
| 116 mA±10% @ 500Ω | |||||
| 81 mA ±10% @ 2 kΩ | |||||
| 15 mA ±10% @ 10 kΩ | |||||
| Muscle Relaxation:116 mA ±10% @ 500Ω81 mA±10% @ 2 kΩ16 mA ±10% @ 10 kΩ | |||||
| For P7:95mA±10% @ 500Ω;52mA ±10% @ 2kΩ;11mA±10% @ 10kΩ | Pain Relief TENS:18[mA] peak±10% @10[kΩ]86[mA] peak±10% @2[kΩ]116[mA] peak±10% @500[Ω] | ||||
| Frequency range | 1~120Hz | Endurance:10 [Hz] | For TENS mode and PMSmode:1 to 100 ±10% [Hz] | Different, but doesnot raise differentquestions of safety andeffectiveness. | |
| Characteristic | New Device | Predicate Device I | Predicate Device II | Comparison | |
| Resistance:50 [Hz] | See Note 6 | ||||
| Strength:75 [Hz] | |||||
| Explosive Strength:100 [Hz] | |||||
| Potentiation:From 1 to 75 [Hz] | |||||
| Training Recovery:10 [Hz] | |||||
| Competition Recovery:0.5 [Hz] | |||||
| Pre-Warmup4 [Hz] | |||||
| Muscle Relaxation:1 [Hz] | |||||
| Pain Relief TENS: | |||||
| Characteristic | New Device | Predicate Device I | Predicate Device II | Comparison | |
| 5 to 122[Hz] | |||||
| Pulse width range | P1-P6: Treatment 200~400μs;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 6Remarks: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] (measuredat 50% of positive pulse) | P6 is compared toTraining Recovery;P7 is compared to PainRelief TENS modeCompared withpredicate device II:P1 to P6 is compared toPMS mode;P7 is compared toTENS mode | ||||
| Pulse duration | 0.5s-2s | Not publicly available | 10 ms-1000ms | Different, but does notraise different questionsof safety andeffectiveness.See Note 6 | |
| Net Charge | 0uC @ 500Ω | Endurance:0 [μC] @ 500ΩExcitation pulse fullycompensated | 0uC @ 500Ω | Different, but doesnot raise differentquestions of safety andeffectiveness.See Note 7 | |
| Characteristic | New Device | Predicate Device I | Predicate Device II | Comparison | |
| Resistance:0 [μC] @ 500ΩExcitation pulse fullycompensatedStrength:0 [μC] @ 500ΩExcitation pulse fullycompensatedExplosive Strength:0 [μC] @ 500ΩExcitation pulse fullycompensatedPotentiation:0 [μC] @ 500ΩExcitation pulse fullycompensatedTraining Recovery: | |||||
| Characteristic | New Device | Predicate Device I | Predicate Device II | Comparison | |
| 0 [ $ \u03bc $ C] @ 500Ω | |||||
| Excitation pulse fully | |||||
| compensated | |||||
| Competition Recovery: | |||||
| 0 [ $ \u03bc $ C] @ 500Ω | |||||
| Excitation pulsefully | |||||
| compensated | |||||
| Pre Warm up | |||||
| 0 [ $ \u03bc $ C] @ 500Ω | |||||
| Excitation pulse fully | |||||
| compensated | |||||
| Muscle Relaxation: | |||||
| 0 [ $ \u03bc $ C] @ 500Ω | |||||
| Excitation pulse fully | |||||
| Compensated | |||||
| Pain Relief TENS: | |||||
| 0 [ $ \u03bc $ C] @ 500Ω | |||||
| Characteristic | New Device | Predicate Device I | Predicate Device II | Comparison | |
| Excitation pulse fullycompensated | |||||
| Maximum CurrentDensity | P1: 0.082mA/c m² @ 500Ω,P2: 0.011mA /cm²@ 500Ω,P3: 0.079mA/c m² @500Ω,P4: 0.110mA/cm²@500Ω,P5: 0.055mA/cm²@500Ω,P6: 0.007mA/cm²@500Ω,P7: 0.031mA/cm²@500Ω | 4.8 [mA/cm2] @ 500Ω | 0.06mA@500 Ω | Different, but does notraise different questions ofsafety and effectiveness.See Note 7 | |
| Maximum PowerDensity | P1: 85.202mW/cm² @500Ω,P2: 1.480mW/cm² @500Ω,P3: 78.96mW/cm²@500Ω,P4: 150.262mW/cm²@500Ω,P5: 37.647mW/cm²@500Ω,P6: 0.551mW/cm² @500Ω,P7: 12.32mW/cm²@500Ω | 27.6 [mW/cm2] @ 500Ω | 1.57 mW/cm² @500Ω, | Different, but does notraise different questions ofsafety and effectiveness.See Note 7 | |
| Characteristic | New Device | Predicate Device I | Predicate Device II | Comparison | |
| Electrical Safety,EMC | Compliant with requirements ofIEC 60601-1, IEC60601-2-10,IEC 60601-1-2, 1. IEC60601-1-11, IEC 62133-2safety standards | IEC 60601-1, IEC 60601-1-2, IEC60601-2-10, FCC part 15 subpart Cand B1 | AAMI/ANSI ES 60601-1, IEC60601-1-2, IEC 60601-2-10,IEC 62133, IEC 60601-1-11 | Same |
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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.
§ 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).