(220 days)
TENS (TENS 1 and TENS 2)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.
PMS (STIM1 STIM2 STIM3 and STIM4)
To stimulate healthy muscles in order to improve and facilitate muscle performance.
The Electrical Stimulator System delivers electric pulses to the user's body areas in shoulder, waist, back, arm, and leg. The portable and compact device has multiple modes frequencies, including transcutaneous electrical nerve stimulation (TENS) and power muscle stimulation (PMS) that is also called Electical Muscle Stimulation (EMS). It includes the operating elements of an M button, intensity increase button, intensity decrease button, and can be attached and detached to electrodes.
The provided document is an FDA 510(k) Premarket Notification review, not a study report. It states that no clinical test data was used to support the decision of substantial equivalence (Section 12). Therefore, the document does not contain the information requested about acceptance criteria, study details, sample sizes, expert involvement, or MRMC studies for a device performance study.
The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technical characteristics, performance specifications, and compliance with recognized standards through non-clinical bench tests.
Based on the information provided in the document, here's what can be extracted, and what cannot be answered as it pertains to a clinical performance study:
Information NOT available from this document regarding a device performance study:
- A table of acceptance criteria and the reported device performance for a clinical study. (No clinical study performed)
- Sample sizes used for the test set and the data provenance. (No clinical study performed)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts. (No clinical study performed)
- Adjudication method for the test set. (No clinical study performed)
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done. (No clinical study performed)
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done. (Not applicable, this is a hardware stimulator, not an AI/algorithm-based device)
- The type of ground truth used. (No clinical study performed)
- The sample size for the training set. (Not applicable, not an AI/ML device that requires a training set)
- How the ground truth for the training set was established. (Not applicable)
Information available from this document regarding the basis for market clearance:
The acceptance criteria and "study" proving the device meets these criteria are primarily based on non-clinical testing and comparison to predicate devices, rather than a clinical performance study involving human patients.
1. Acceptance Criteria and Reported Device Performance (Non-Clinical / Bench Testing)
The document primarily relies on compliance with a set of international and FDA-recognized standards as its acceptance criteria for device safety and performance. The "reported device performance" refers to the successful testing to these standards and the comparison of technical specifications to predicate devices.
| Acceptance Criteria (Compliance with Standards) | Reported Performance (Compliance Demonstrated) | Specific Tests Mentioned |
|---|---|---|
| Electrical Safety | Device demonstrated electrical safety. | IEC 60601-1:2012+A2:2020 Medical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance. |
| Electromagnetic Compatibility (EMC) | Device demonstrated EMC. | IEC 60601-1-2:2014 /AMD1:2020 Medical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance --Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests. |
| Basic Safety and Essential Performance (General & Home Healthcare) | Device meets basic safety and essential performance requirements. | IEC 60601-1-11:2020: General Requirements For Basic Safety And Essential Performance - Collateral Station of Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment. |
| Specialized Safety (Nerve & Muscle Stimulators) | Device meets specific safety requirements for stimulators. | IEC 60601-2-10:2012 +A1:2016+A2:2023 medical electrical equipments for the basic safety and essential performance of nerve and muscle stimulators. |
| Usability | Device meets usability requirements. | IEC 60601-1-6 :2010+A1:2013+A2:2020 Medical Electrical Equipment For Basic Safety And Essential Performance -Collateral Standard: Usability. |
| Software Verification and Validation | Software verified and validated. | Compliance with FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Software Contained in Medical Devices." (Software deemed "Moderate" level of concern). |
| Biocompatibility | Device materials are biocompatible with human contact. | ISO 10993-1:2009 Biological evaluation of medical devices-Parts 1: Evaluation and testing. ISO 10993-10:2021 Biological evaluation of medical devices-Parts 10: Tests for skin sensitization. ISO 10993-23:2021 Biological evaluation of medical devices-Parts 10: Tests for irritation. |
| Functional Performance (Output Characteristics vs. Predicate Range) | Device's functional parameters are within acceptable ranges of predicates. | Bench tests were conducted to verify parameters such as waveform, stimulation parameters (maximum output voltage, current, etc.), and current distribution on electrodes against the characteristics of legally marketed predicate devices. (Specific quantitative results compared in Table 1 and 2 of the document). |
2. Sample Sizes Used for the Test Set and Data Provenance:
- Sample Size: Not applicable. The "test set" here refers to the physical device prototypes undergoing non-clinical bench testing, not a dataset of patient cases. The number of physical units tested is not specified but is assumed to be standard for device verification.
- Data Provenance: The tests were conducted by the manufacturer (Gymmax Technology Shenzhen Co., Ltd.) or contracted labs in China, as indicated by the company's address and the application correspondent's company (IMD Medical & Drug Technology Services Institutions) also based in China. The data provenance is from non-clinical bench testing, not from human subjects, and therefore is not retrospective or prospective in the clinical sense.
3. Number of Experts and Qualifications:
- Experts: Not applicable for establishing ground truth as no clinical ground truth was established by human experts for device performance. Ground truth would be defined by the measurement standards of the bench tests themselves.
- Qualifications: Not applicable.
4. Adjudication Method:
- Method: Not applicable. No human interpretation or adjudication of test results, beyond standard engineering and quality control procedures, is mentioned for the bench tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was it done? No. The document explicitly states "No clinical test data was used to support the decision of substantial equivalence" (Section 12). This type of study is relevant for AI/ML diagnostic interpretation devices, not for a physical stimulator.
- Effect Size: Not applicable.
6. Standalone Performance (Algorithm Only):
- Was it done? Not applicable. This device is an Electrical Stimulator System, a physical medical device, not an AI algorithm.
7. Type of Ground Truth Used:
- For Non-Clinical Tests: The ground truth is established by engineering specifications, international consensus standards (e.g., IEC, ISO), and the performance characteristics of legally marketed predicate devices. The device needs to demonstrate that its electrical outputs, safety features, and material properties are compliant with these standards and comparable to accepted devices.
8. Sample Size for the Training Set:
- Sample Size: Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established:
- Method: Not applicable.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 21, 2024
Electronic Pulse Stimulator % Salon Chen System Engineer IMD Medical & Drug Technology Services Institutions Room 308, Building 11, No. 23 Jinqu Road Wanjiang District, Dongguan City ShenZhen City, Guangdong Province 518117 China
Re: K232439
Trade/Device Name: Electrical Stimulator System Regulation Number: 21 CFR 882.5890; 21 CFR 890.5850 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: February 20, 2024 Received: February 20, 2024
Dear Salon Chen:
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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
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Sincerely,
Robert Kang -S
for Pamela Scott
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) K232439
Device Name Electrical Stimulator System
Indications for Use (Describe)
TENS (TENS 1 and TENS 2)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.
PMS (STIM1 STIM2 STIM3 and STIM4)
To stimulate healthy muscles in order to improve and facilitate muscle performance.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 34 CFR 301 Subpart D) | Over-The-Counter Use (34 CFR 301 Subpart C) |
|---|---|
| ----------------------------------------------------------------------- | --------------------------------------------------------------------------------- |
__ 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- K232439
1. Submitter's Identification:
- Company Name: Gymmax Technology Shenzhen Co., Ltd. >
- ハ Establishment Registration Number: 3007689716
- ▲ Address:5F 4th Bldg., Heping Complex (4th Bldg. Huimingsheng Technology Park) Fuhai Subdistrict, Baoan District Shenzhen City, Guangdong Province 518103 P.R.C.
- A Phone: +86-755-2912-4050
- ♪ Fax: +86-755-2912-4050
- Contact Person (Title): Benson Wang (General Manager) A
- E-mail: benson_gmx@qq.com ハ
-
Date of Preparation: Feb.19, 2024
2. Name of the Device:
- Electrical Stimulator System A
- Models: GMX-007 and GMX-006 A
-
- Common Name and Classification:
- Stimulator, Nerve, Transcutaneous, Over-The-Counter A
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- ♪ Classification Product Code: NUH, NGX
-
Regulation Number:21 CFR 882.5890
-
Class: Il
4. Predicate Device Information1:
- ハ 510(k) Number: K171803
-
Predicate Device Name: HIVOX OTC Electrical Stimulators Model SEM44 and Model SEM44-1
- Manufacturer: HivoxBiotek Inc. A
- This predicate has not been subject to a design-related recall A
- A No reference devices were used in this submission.
-
- Predicate Device Information2:
- A 510(k) Number: K133929
- Predicate Device Name: Health Expert Electronic Stimulator, Model AST300Cand AST-300D A
- Manufacturer: Shenzhen OSTO Technology Company Limited A
- This predicate has not been subject to a design-related recall A
- A No reference devices were used in this submission.
-
- Predicate Device Information3:
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- 510(k) Number: K130802 A
- Predicate Device Name: OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060) >
-
Manufacturer: SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD
- This predicate has not been subject to a design-related recall A
- No reference devices were used in this submission. A
-
- Application Correspondent
- A Company Name: IMD Medical & Drug technology service institutions
- Phone: +86-18613190779 A
- A Fax: +86-755-62809168
- Contact Person (Title): Salon Chen (System engineer) A
- A E-mail: 33999439@qq.com
- Address: Room 308, Building 11, No. 23 Jinqu Road, Wanjiang District, Dongguan City, Guangdong Province, China A
8. Device Description
The Electrical Stimulator System delivers electric pulses to the user's body areas in shoulder, waist, back, arm, and leg. The portable and compact device has multiple modes frequencies, including transcutaneous electrical nerve stimulation (TENS) and power muscle stimulation (PMS) that is also called Electical Muscle Stimulation (EMS). It includes the operating elements of an M button, intensity increase
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button, intensity decrease button, and can be attached and detached to electrodes.
The electrodes cleared include accessory electrodes, which may be packaged separately and/or together with the subject device.
The associated accessories include:
Belt * 1
Control Unit * 1
USB Charging Cable * 1
Belt Extension Kit * 1
Storage pouch * 1
9. Indications for Use
TENS (TENS 1 and TENS 2)
To be used for temporary relief of pain associated with shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.
PMS (STIM1、STIM2、STIM3 and STIM4)
To stimulate healthy muscles in order to improve and facilitate muscle performance.
10. Comparison to the predicate device
Electrical stimulation is the technological princes and predicate device. In the EMS modes, electronic pulses are sent through electrode passively exercise the affected muscle receives this signal, it contracts and flexes naturally, as it would during physical
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exercise. And like with physical exercise, when the muscle relates and the cycle can start over again. In the TENS modes, the gentle electrical pulses were sent through electrode pass and into stir to block or shut out the brain from the source of the pain.
Table 1: Technological Characteristics
| Elements of Comparison | Proposed Device | Predicate Device1(K171803) | Predicate Device2(K133929) | Predicate Device3(K130802) | Judgment | ||
|---|---|---|---|---|---|---|---|
| Company Name | Gymmax TechnologyShenzhen Co., Ltd. | HIVOX BIOTEK INC. | Shenzhen OSTOTechnology CompanyLimited | SHENZHEN DONGDIXINTECHNOLOGY CO, LTD | / | ||
| Device Name | Electrical StimulatorSystem | HIVOX OTC ElectricalStimulator/SEM44 | Health Expert ElectronicStimulator, Model AST300Cand AST-300D | OTC ELECTRICAL STIMULATOR(MT9001), OTC TENS DEVICE(LT3060) | / | ||
| Classification Product Code | NUH | NUH | NUH | NUH | SE | ||
| Subsequent Product Codes | NGX | NGX | NGX | NGX | SE | ||
| Regulation | 21 CFR 882.5890 | 21 CFR 882.5890 | 21 CFR 882.5890 | 21 CFR 882.5890 | SE | ||
| Classification Name | Transcutaneous electricalnerve stimulator for painrelief | Transcutaneouselectrical nervestimulator for painrelief | Transcutaneous electricalnerve stimulator for painrelief | Transcutaneous electrical nervestimulator for pain relief | SE | ||
| Class | 2 | 2 | 2 | 2 | SE | ||
| Prescription or OTC | OTC | OTC | OTC | OTC | SE | ||
| Functions and design | Electrical stimulation | Electrical stimulation | Electrical stimulation | Electrical stimulation | SE | ||
| Power Source(s) | Rechargeable battery | 4.5V (batteries,3×1.5V AAA) | Adaptor Input: 100- 240Vac,50-60Hz, 0.1A Output: 5Vdc,1A Unit Input: 5Vdc, 1A | 9V batteries | SE | ||
| Method of Line CurrentIsolation | Type BF Applied Part | N/A | Type BF Applied Part | N/A | SE | ||
| PatientLeakageCurrent | Normal condition | N/A | N/A | AC: 54.5μA, DC: 0.5μA | 0.61μA | SE | |
| Single faultcondition | N/A | N/A | AC:120.0μA,DC: 0.6μA | 0.68μA | SE | ||
| Number of Output Modes | TENS: 2EMS: 4 | EMS: 35TENS:15 | EMS: 8TENS:17 | TENS: 1EMS: 1 | SENote 3 | ||
| Number of Output Channels | 1 | 2 | 2 | N/A | SENote 3 | ||
| SynchronousorAlternating | N/A | Synchronous | Synchronous | Alternating | SE | ||
| Method of Channel Isolation | By electrical circuit andsoftware | By electrical circuit andsoftware | Voltage Transform Isolation"BODY▼" and "BODY▼"buttons for body channel,"SOLE▲" and "SOLE▼"buttons for feet channel | By electrical circuit andsoftware | SE | ||
| Regulated Current orRegulated Voltage? | Current control | Regulated voltage | Current control | Current control | SE | ||
| Software/Firmware/Microprocessor Control | Yes | Yes | Yes | Yes | SE | ||
| Automatic Overload Trip? | No | Yes | No | Yes | SE | ||
| Automatic No-Load Trip? | Yes | Yes | No | Yes | SE | ||
| Automatic Shut Off? | Yes | Yes | Yes | Yes | SE | ||
| Patient Override Control? | Yes | Yes | Yes | Yes | SE | ||
| On/Off Status? | Yes | Yes | Yes | Yes | SE | ||
| Indicator Display | Low Battery? | Yes | Yes | Yes | Yes | SE | |
| Voltage/CurrentLevel? | Yes | Yes | Yes | Yes | SE | ||
| Timer Range (minutes) | 30minutes | 5~100minutes | 25 minutes | 1-60 minutes | SENote 3 | ||
| Weight | 40.6G [without pad] | 89g (including beltclip,without batteries)123g (including beltclip,and batteries) | 2Kg (Without accessories) | 128g (including batteries) | SENote 4 | ||
| Dimensions (in.) [W x H x D] | 755513.8 mm | 132 x 63 x29.5mm (includingbeltclip) | 428mm x 428.8mm x185mm | 117 x 60 x 34 mm | SENote 4 | ||
| Housing Materials andConstruction | ABS+PC | ABS | ABS | ABS | SE | ||
| Intended Use | TENS (TENS 1 and TENS2)To be used for temporaryrelief of pain associatedwith sore and achingmuscles in the shoulder,waist, back, arm, and leg,due to strain from exerciseor normal household andwork activities. | SEM44 (EMS): Thedevice is designed tobe used for stimulatehealthy muscles inorder to improve andfacilitate muscleperformance.SEM44 (TENS): Thedevice is designed tobe used for temporaryrelief of painassociated with soreand aching muscles in | PMS (Mode 1~8) It isintended to stimulate healthymuscles in order to improveand facilitate muscleperformance. | MT9001 -TENS: The device is designed tobe used for temporary relief of painassociated with sore and achingmuscles in the shoulder, waist,back, neck, upper extremities(arm), and lower extremities (leg)due to strain from exercise ornormal household work activities.EMS: The device is designed to beused for stimulate healthy musclesin order to improve and facilitatemuscle performance. | SENote 1 | ||
| Intended Use | PMS (STIM1 、STIM2STIM3 and STIM4)To stimulate healthymuscles in order to improveand facilitate muscleperformance. | SEM44-1 -TENS: The device isdesigned to be usedfor temporary relief ofpain associated withsore and achingmuscles in theshoulder, waist, back,neck, upperextremities (arm),lower extremities(leg), abdomen andbottom due to strainfrom exercise ornormal householdwork activities. | TENS (Mode 9~25)To be used for temporaryrelief of pain associated withsore and aching muscles inthe shoulder, waist, back,back of the neck, arm, leg,and foot due to strain fromexercise or normalhousehold work activities byapplying current to stimulatenerve. | LT3060 -TENS: The device is designed tobe used for temporary relief of painassociated with sore and achingmuscles in the shoulder, waist,back, neck, upper extremities(arm), and lower extremities (leg)due to strain from exercise ornormal household work activities. | SENote 1 | ||
| Safety factor & Performance | Proposed Device | Predicate Device1 | Predicate Device2 | Predicate Device3 | Judgment | ||
| Electrical Safety | Compliance with IEC 60601-1 | Compliance with IEC 60601-1 | Compliance with IEC 60601-1 | Compliance with IEC 60601-1 | SE | ||
| EMC | Compliance with IEC 60601-1-2 | Compliance with IEC 60601-1-2 | Compliance with IEC 60601-1-2 | Compliance with IEC 60601-1-2 | SE | ||
| Biocompatibility | Compliance with ISO 10993-1 | Compliance with ISO 10993-1 | Compliance with ISO 10993-1 | Compliance with ISO 10993-1 | SE | ||
| Performance | Compliance with IEC 60601-2-10:2012 medical electrical equipment - part 2-1 | Compliance with IEC 60601-2-10:2012 medical electrical equipment - part 2-1 | Compliance with IEC 60601-2-10:2012 medical electrical equipment - part 2-1 | Compliance with IEC 60601-2-10:2012 medical electrical equipment - part 2-1 | SE | ||
| Waveform | Biphasic, symmetrical | Biphasic, square | Pulsed, symmetric, Biphasic, Rectangular | Biphasic Square | SE | ||
| Burst Mode | Pulses per burst | 2 | 3 | -- | 7 | N/A | SE |
| Bursts per second | 5 / 50Hz | 2/60Hz | -- | 0.5/1/2/3/4/5 Hz | N/A | SE | |
| Burst Mode | Burst duration (seconds) | 20ms | 36ms | -- | 70ms | N/A | SE |
| DutyCycle[Line(b) xLine (c)] | 20ms/100ms | 36ms/390ms | -- | 35ms/350ms | N/A | SE | |
| ON Time (seconds) | 0.25s~6.5s | 2s | 0.6s | N/A | 1-30 | SE | |
| OFF Time (seconds) | 0.25s~4.6s | 2s | 0.6s | N/A | 1-60 | SE | |
| Maximum outputvoltage (volts+/-20%)at 500Ω | TENS 1:112TENS 2: 114STIM1:116STIM2:116STIM3:76STIM4: 70 | 100±10 % (50±10 %(Vp)) | 44±10% | 96±20%(48±20% (Vp)) | (Note 1) | ||
| Maximum outputvoltage (volts+/-20%)at 2KΩ | TENS 1: 250TENS 2: 240STIM1: 250STIM2: 250STIM3: 158STIM4: 146 | 180±10 % (90±10 %(Vp)) | 80±10% | 200±20%(100±20%(Vp)) | 228±20%(114±20%(Vp)) | (Note 2) | |
| Maximum outputvoltage (volts+/-20%)at 10KΩ | TENS 1: 300TENS 2: 286STIM1: 310STIM2: 308STIM3: 278STIM4: 276 | 250±10 %(125±10 %(Vp)) | 112±10% | 210±20%(105±20%(Vp)) | 230±20%(115±20%(Vp)) | (Note 2) | |
| Maximum outputcurrent (mA+/-20%) at500Ω | TENS 1: 224TENS 2: 228STIM1: 232STIM2: 232STIM3: 152STIM4: 140 | $200\pm10 %$$(100\pm10 %(Ip))$ | $88\pm10%$ | $96\pm20%$ | (Note 2) | ||
| Maximum outputcurrent (mA+/-20%) at2KΩ | TENS 1:125TENS 2: 120STIM1: 125STIM2: 125STIM3:79STIM4: 73 | $90\pm10 % (45\pm10 %(Ip))$ | $40\pm10%$ | $50\pm20%$ | $57\pm20%$ | (Note 2) | |
| Maximum outputcurrent (mA+/-20%) at10KΩ | TENS 1: 30TENS 2: 28.6STIM1: 31STIM2:30.8STIM3: 27.8STIM4: 27.6 | $25\pm10 % (12.5\pm10 %(Ip))$ | $11.2\pm10%$ | $10.5\pm20%$ | $11.5\pm20%$ | (Note2) | |
| Pulse period (mSec) | 20~200 | 50-450µs | 120µs | 50-300µs | (Note 2) | ||
| Frequency (Hz) | TENS 1: 33TENS 2: 5STIM1:37STIM2:25STIM3: 5STIM4: 50 | 1-150Hz | 77.3Hz | 1-150Hz | (Note 2) |
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Table 2: Output Specifications
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| Maximum Phasecharge(µC) at 500Ω | TENS 1: 11TENS 2: 11STIM1: 11.4STIM2: 10.6STIM3: 22.8STIM4: 20.4 | 0.045 | 12.78μC @ 500Ω | 0.0288@500Ω(mC) | (Note 2) |
|---|---|---|---|---|---|
| Maximum chargedensity(mA/cm2) at500Ω | TENS 1: 0.024TENS 2: 0.01STIM1:0.027STIM2: 0.021STIM3: 0.021STIM4: 0.059 | 0.667 | 0.235mA/cm² @ 500Ω | 1.15@500Ω | (Note 2) |
| Maximum averagepowerdensity(mw/cm²) at500Ω | TENS 1: 1.33TENS 2: 0.554STIM1: 1.54STIM2: 1.13STIM3: 0.793STIM4: 2.01 | 0.0046 | 1.38mW/cm² @ 500Ω | 4.32@500Ω | (Note 2) |
As shown in the above comparison Table, the subject device, have the technical characteristics (such as maximum output voltage, maximum output current, maximum average power density) in similarity to the predicate device. Acoordingly, we are substantially equivalent to the predicate device HIVOX OTC Electrical Stimulators Model SEM44-1 (K171803) &Health Expert Electronic Stimulator, Model AST300Cand AST-300D (K133929) &OTC ELECTRICAL STIMULATOR (MT9001) &OTC TENS DEVICE (LT3060),
Design and Technology –The basic design and technology of providing electrical stimulation is the same or similar.
Performance and Specifications – The subject device has similar electrical stimulation and specifications to the predicate device.
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Indications - The indications are same.
Review of Differences:
Note 1:
The "Intended Use" of the subject device is the substantially equivalent to the predicate devices selected TENS
(Transutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscle Stimulation) technologies to the treatment of temporary relef of pain associate with sore and aching muscle performance improvement of heathy muscles respectively. Meanvhile, the" Product Code" of the subject device is the same as the predicate devices. This define does not affect the intended use or normal use of the subject device.
Note 2:
The maximum out voltage and maximum output current under 500 Ω. 2Κ.Ω and 10Κ.Ω resistance of candidate device due to different design. The performance test was conducted to verify the maximum out current of candidate device under the acceptance criteria followed IEC 60601-2-10:2012 +A1:2016+A2:2023 。
The candidate device has also demonstrated the electrical safety by passing 60601-1:2012+A2:2020, IEC 60601-1-11:2020 and IEC 60601-2-10:2012 +A1:2016+A2:2023, therefore, the different maximum out voltage will not affect the electrical safety of the candidate device. We have found 510(K) cleared reference deviceK171803 has difference maximum output voltage and maximum out current with the candidate device, which demonstrate that the design of candidate device doesn't impact and effectiveness.
Pulse Width
The difference in pulse width between the predicate device is having different sensation when delivered to human body. Different p ulse with will lead to different output charge.The bigger pulse width. A large mount of charge will give more obviou
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s sensation to human body, but the charge is still within the required safety performance range according to the safety calculation.
Therefore, the difference does not raise new questions of safety and effectiveness as compared to the predicate devices.
Maximum Phase Charge
The reason that the subject device's phase charge is because the allowed voltage is higher than predicate device's at 5000. However, the subject device's phase charge is still in the safety range. In addition, the negative phase charge are always balanced out. Therefore, the difference does not raise new questions of safety and effectiveness as compared to the predicate devices.
Frequency range
Frequency for the subject device is 5-50Hz and it fals into frequency of 1-150 Hz. So the difference doesn't raise new questions of safety and effectiveness. This difference doesn't raise new questioness. As demonstrated, the differences between the subject and predicate devices do not affect the intended use or aller the device. There are no new safety or effectiveness issues concerning the subject device, which offers substant technical specifications, features, intended use, safety, and effectiveness as the predicate device. Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
Note 3:
Although the " Number of Output Modes", "Number of Output Channels" of the subject device are a little different from the predicate devices, they are all complaint with requirement of IEC6060-1:2012+A2:2020、IEC 60601-1-2:2014 /AMD1:2020 and IEC 60601-2-10:2012 +A1:2016+A2:2023 standard. So these differences will not raise any safety or effectiveness issue.
Note 4:
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Although the "Weight" and "Dimensions" of the subject devices, these differences are insignificant in the terms of safety or effectiveness.
- Electrical safety
IEC6060-1:2005+A1:2012+A2:2020 Medical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance.
2) Electromagnetic compatibility (EMC)
IEC 60601-1-2:2014 /AMD1:2020 Medical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance --Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests.
3) Basic Safety and Essential Performance
IEC 60601-1-11:2020: General Requirements For Basic Safety And Essential Performance - Collateral Station of Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment.
IEC 60601-2 10:2012 +A1:2016+A2:2023medical electrical equipments for the basic safety and essential performance of nerve and muscle stimulators.
IEC 60601-1-6 :2010+A1:2013+A2:2020Medical Electrical Equirements For Basic Safety And Essential Performance -Collateral Standard: Usability.
Software Verification and Validating Testing 4)
Software verification and validation testing were conducted as recommended by FDA's Guidance for Industry and FDA
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Staff, "Guidance for the Content of Premarket Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern.
Biocompatibility testing 5)
ISO 10993-1:2009 Biological evaluation of medical devices-Parts 1: Evaluation and testing.
ISO 10993-10:2021 Biological evaluation of medical devices-Parts 10: Tests for skin sensitization
ISO 10993-23:2021 Biological evaluation of medical devices-Parts 10: Tests for irritation
11. Discussion of Non-clinical Tests Performed for Determination of Substantial Equivalence are as follows:
The proposed device is the same as the predicate devices are different. A series of safety and performance tests were conducted on the subject device:
Biocompatibility
Software Validation
Electromagnetic compatibility and electrical safety
Function test (Including output waveform, stimulation parameters and current distribution on
the electrodes)
All the test results demonstrate Election meets the requirements of its pre-defined acceptance criteria and intended uses, and is substantially equivalent to the predicate devices.
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12. Clinical Tests Performed
No clinical test data was used to support the decision of substantial equivalence.
13. Conclusion
The subject devices have all features of the few differences do not affect the safety and effectiveness of the subject devices.
Thus, the subject devices are substantially equivalent to the predicate devices.
§ 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).