(150 days)
TENS:
[RS-18, RS-28, RS-38 models]: For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
[RS-18, RS-38 models]: For temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medications.
[RS-18, RS-28 models]: It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
EMS:
[RS-18. RS-28]: To stimulate healthy muscles in order to improve and facilitate muscle performance.
Environments of Use: Clinics, hospital and home environments (over-the-counter) Patient Population: Adult
"Wireless Electrical Stimulator" is a battery-powered wireless electrical stimulator designed and intended to provide Transcutaneous Electrical Nerve Stimulation (TENS) and Electrical Muscular Stimulation (EMS) for the use of non-pharmacological pain relief and improve muscle performance and recovery.
The "Wireless Electrical Stimulator" includes a remote control, stimulator pod(s) and several accessories. Both the remote control and the stimulator pod are powered by a 3.7V lithium-ion polymer battery. The remote control has a 1.77" TFT LCD screen and 4 buttons to control multiple stimulator pod(s) at the same time. Each stimulator pod has two output channels, and will perform electrical stimulation according to the parameter settings sent by the remote control. The stimulator pods can also be used independently via its own 3 buttons based on preset parameter.
The accessories include self-adhesive electrodes, kneelelbow brace, and the USB Type-C charging cable. The adhesive electrodes for "Wireless Electrical Stimulator" are connected with the Stimulator Pod(s) via magnetic snap and lead wire. There are replaceable hydrogel pads on the self-adhesive electrode pads. Users can replace the hydrogel when it exceeds its useful life, but does not need to discard the entire electrode. To apply electrical stimulation to body joints (e.g. knees and elbows), users can easily place electrodes on specific body parts using the Knee/elbow brace. The remote control and stimulator pods are the same for all models. The 3 models have different accessories to match their specific usage instructions.
The provided text is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) / Electrical Muscle Stimulator (EMS) device. It details the device's characteristics, comparison to predicates, and performance testing for FDA clearance.
However, the provided text DOES NOT contain the type of AI/ML-specific acceptance criteria and study information requested in the prompt. The device is a medical stimulator, not an AI/ML-driven diagnostic or prognostic tool. Therefore, information like "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the-loop performance)," "ground truth established by experts/pathology," or sample sizes for training/test sets for AI models are not applicable to this document.
The document focuses on demonstrating substantial equivalence to legally marketed predicate devices through comparisons of indications for use, technological characteristics, and various non-clinical performance data (biocompatibility, electrical safety, EMC, software verification, human factors, bench testing).
Therefore, I cannot populate the requested table or answer the specific questions related to AI/ML acceptance criteria and studies based on the provided text.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.
September 1, 2022
ZMI Electronics Ltd. Yuta Lee President 6F-1, 286-4, Shin Ya Road Kaohsiung, R.O.C. 806 Taiwan
Re: K220997
Trade/Device Name: Wireless TENS/EMS, Bruno, Aela Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH, NGX, NYN Dated: July 29, 2022 Received: August 2, 2022
Dear Yuta Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal 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
{1}------------------------------------------------
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 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).
Sincerely.
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) K220997
Device Name
Wireless Electrical Stimulator (Models RS-18, RS-28, RS-38)
Indications for Use (Describe)
TENS:
[RS-18, RS-28, RS-38 models]: For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
[RS-18, RS-38 models]: For temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medications.
[RS-18, RS-28 models]: It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
EMS:
[RS-18, RS-28 models]: To stimulate healthy muscles in order to improve and facilitate muscle performance.
Environments of Use: Clinics, hospital and home environments (over-the-counter) Patient Population: Adult
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
1. Submitter Information
Applicant Name: ZMI Electronics Ltd. Address: 6F-1, 286-4, Shin-Ya Road, Kaohsiung, Taiwan 806 Phone: +886-7-8150053 Fax: +886-7-8150057 E-mail: mail@zmi-electronics.com
Contact Person
Name: Lawrence Liu Title: Regulatory Affairs Manager Phone: +886-7-8150053 Ext 351 Fax: +886-7-8150057 E-mail: lawrence@zmi-electronics.com
Date Summary Prepared: February 10, 2022
2. Device Information
Device Name: Wireless Electrical Stimulator Model: RS-18, RS-28, RS-38 Regulation Number: 21 CFR 882.5890 Classification Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH Subsequent Product Code: NGX, NYN
3. Predicate device
Primary Predicate
510K Number: K161453 Device Name: Well Life Wireless TENS/EMS Stimulator, Models WR-2605A/2605 Regulation Number: 21 CFR 882.5890 Classification Name: Transcutaneous electrical nerve stimulator for pain relief Requlatory Class: Class II Product Code: NUH Subsequent Product Code: NGX, NYN
Secondary Predicate
510K Number: K183215 Device Name: Focus TENS Therapy, Model PM710-M/-L Requlation Number: 21 CFR 882.5890
Classification Name: Transcutaneous electrical nerve stimulator for pain relief
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Requlatory Class: Class II Product Code: NUH Subsequent Product Code: NYN
Third Predicate
510K Number: K183110 Trade/Device Name: Livia Regulation Number: 21 CFR 882.5890 Classification Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH Subsequent Product Code: NGX
4. Device Description
"Wireless Electrical Stimulator" is a battery-powered wireless electrical stimulator designed and intended to provide Transcutaneous Electrical Nerve Stimulation (TENS) and Electrical Muscular Stimulation (EMS) for the use of non-pharmacological pain relief and improve muscle performance and recovery.
The "Wireless Electrical Stimulator" includes a remote control, stimulator pod(s) and several accessories. Both the remote control and the stimulator pod are powered by a 3.7V lithium-ion polymer battery. The remote control has a 1.77" TFT LCD screen and 4 buttons to control multiple stimulator pod(s) at the same time. Each stimulator pod has two output channels, and will perform electrical stimulation according to the parameter settings sent by the remote control. The stimulator pods can also be used independently via its own 3 buttons based on preset parameter.
The accessories include self-adhesive electrodes, kneelelbow brace, and the USB Type-C charging cable. The adhesive electrodes for "Wireless Electrical Stimulator" are connected with the Stimulator Pod(s) via magnetic snap and lead wire. There are replaceable hydrogel pads on the self-adhesive electrode pads. Users can replace the hydrogel when it exceeds its useful life, but does not need to discard the entire electrode. To apply electrical stimulation to body joints (e.g. knees and elbows), users can easily place electrodes on specific body parts using the Knee/elbow brace. The remote control and stimulator pods are the same for all models. The 3 models have different accessories to match their specific usage instructions. Below are the accessory variants for each model.
| Product Name | Wireless TENS/EMS | Brace TENS/EMS | Menstrual Pain ReliefTENS |
|---|---|---|---|
| Model | RS-18 | RS-28 | RS-38 |
| Indication of Use | General TENS/EMS | TENS/EMS for joint(knee & elbow) | TENS for period pain(dysmenorrhea) |
| Adhesive Electrodes | ● | ● | ● |
| Electrode Lead Wire | ● | ● | ● |
| Knee/Elbow Brace | n/a | ● | n/a |
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| USB Type C Charge Cable | • | • | • |
|---|---|---|---|
| ------------------------- | --- | --- | --- |
Besides the accessory variants, the programs of all models also have some variants depend on the indication. RS-18 model has a "General TENS/EMS" indication, it includes all therapy programs. RS-28 model is indicated for "TENS/EMS for joint (knee & elbow)" and the RS-38 model is indicated for "TENS for period pain (dysmenorrhea)." Following are the program variants for each models.
| Therapy Type | Program | RS-18 | RS-28 | RS-38 |
|---|---|---|---|---|
| Pain Relief | Acute Pain | ● | ● | ● |
| Chronic Pain | ● | ● | ● | |
| Soreness | ● | ● | ● | |
| Pain Relief | Back Pain | ● | n/a | ● |
| MenstrualCramping | ● | n/a | ● | |
| Pain Relief | Arthritis | ● | ● | n/a |
| Training | Warm-up | ● | ● | n/a |
| Recovery | ● | ● | n/a | |
| Atrophy | ● | ● | n/a | |
| Strength | ● | ● | n/a | |
| Endurance | ● | ● | n/a | |
| Massage | Resistance | ● | ● | n/a |
| Comfort | ● | ● | ● | |
| Kneading | ● | ● | ● | |
| Tapping | ● | ● | ● | |
| Relaxation | ● | ● | ● | |
| Tingling | ● | ● | ● | |
| Alternating | ● | ● | ● |
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5. Indications for Use
TENS:
[RS-18, RS-28, RS-38 models]: For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
[RS-18, RS-38 models]: For temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medications.
[RS-18, RS-28 models]: It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
EMS:
[RS-18. RS-28]: To stimulate healthy muscles in order to improve and facilitate muscle performance.
Environments of Use: Clinics, hospital and home environments (over-the-counter) Patient Population: Adult
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Comparison of Technological Characteristics with The Predicate Device
The "Wireless Electrical Stimulator" has been carefully compared to legally marketed devices with respect to intended use, indications for use (Table 1), technological characteristics (Table 2), and Output Specification (Table 3).
Table 1. Substantial Equivalence Table – Regulatory Information
| Subject Device | Primary Predicate | Secondary Predicate | Third Predicate | |
|---|---|---|---|---|
| Trade/Device Name | Wireless ElectricalStimulator | Well Life WirelessTENS/EMS Stimulator,Models WR-2605A/2605 | Focus TENS Therapy,Model PM710-M/-L | Livia |
| 510(k) Number | K220997 | K161453 | K183215 | K183110 |
| Manufacturer | ZMI Electronics Ltd. | Well-life HealthcareLimited | Omron Healthcare, Inc. | LifeCare Ltd. |
| ClassificationProduct Code | NUH | NUH | NUH | NUH |
| SubsequentProduct Codes | NGX, NYN | NGX, NYN | NYN | NGX |
| RegulationNumber | 21 CFR 882.5890 | 21 CFR 882.5890 | 21 CFR 882.5890 | 21 CFR 882.5890 |
| Regulation Name | Transcutaneouselectrical nervestimulator for pain relief | Transcutaneouselectrical nervestimulator for pain relief | Transcutaneouselectrical nervestimulator for pain relief | Transcutaneouselectrical nervestimulator for pain relief |
| Regulatory Class | Class II | Class II | Class II | Class II |
| Indications for | For temporary relief of | For temporary relief of | The device is intended | For temporary relief of |
| Use | ||||
| pain associated withsore and achingmuscles in the shoulder,waist, back, neck, upperextremities (arm) andlower extremities (leg)due to strain fromexercise or normalhousehold workactivities. | pain associated withsore and achingmuscles in the lowerback due to strain fromexercise or normalhousehold and workactivities.For temporary relief ofpain associated withsore and achingmuscles in the upperand lower extremities(arm and/or leg) due tostrain from exercise ornormal household andwork activities. | for the relief of painassociated with sore oraching muscles of thelower extremities (leg)due to strain fromexercise or normalhousehold workactivities.It is also intended forthe use of symptomaticrelief and managementof chronic, intractablepain associated witharthritis. | pain associated withsore and achingmuscles in the shoulder,waist, back, neck, upperextremities (arm) andlower (extremities) legdue to strain fromexercise or normalhousehold workactivities. | |
| For temporary relief ofpain associated withdysmenorrhea(menstrual cramps)when used with over-the-counter painmedications. | For symptomatic reliefand management ofchronic, intractable painand relief of painassociated with arthritis. | For temporary relief ofpain associated withdysmenorrhea(menstrual cramps)when used with over-the-counter painmedications. | ||
| For symptomatic reliefand management ofchronic, intractable painand relief of painassociated with arthritis. | For the stimulation ofhealthy muscles inorder to improve or | |||
| To stimulate healthymuscles in order to |
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| improve and facilitatemuscle performance. | facilitate muscleperformance. | |||
|---|---|---|---|---|
| Environments of Use | Clinics, hospital andhome environments(over-the-counter) | for home use, indoor,not intended forprofessional use (over-the-counter) | Clinics, hospital andhome environments(over-the-counter) | home healthcareenvironment (over-the-counter) |
| PatientPopulation | Adult | At least 15 years oldand 8 years intensivereading experience(school), no maximum. | Adult | Be used only by womenaged 16 and above. |
| Over-the-Counter(OTC) | Yes | Yes | Yes | Yes |
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| Subject Device | Primary Predicate | SecondaryPredicate | Third Predicate | ||
|---|---|---|---|---|---|
| Trade/Device Name | Wireless ElectricalStimulator | Well Life WirelessTENS/EMSStimulator, ModelsWR-2605A/2605 | Focus TENSTherapy, ModelPM710-M/-L | Livia | |
| 510(k) Number | K220997 | K161453 | K183215 | K183110 | |
| Power Source(s) | 3.7V Lithiumpolymer (LiPo)battery | 3.7V Lithiumpolymer (LiPo)battery | RechargeableLithium-ion battery | 3.7V Lithium ionbattery(rechargeable) | |
| Method of Line Current | Output is electricallydisabled whenconnect to charger,by means ofmicroprocessorcharging circuit | Output is electricallydisabled whenconnect to charger,by means ofmicroprocessorcharging circuit | N/A (internal powersource) | Output is electricallydisabled whenconnect to charger,by means ofmicroprocessorcharging circuit | |
| Patient Leakage Current | - Normal Condition (µA) | <10uA | <10uA | <10uA | <10uA |
| Patient Leakage Current | - Single Fault Condition (μΑ) | <50uA | <50uA | <50uA | <50uA |
| Average DC current through | electrodes when device is onbut no pulse are beingapplied (uA) | 0 | 0 | 0 | 0 |
| Number of output Modes | 1 | 1 | 1 | 1 | |
| Number of | Synchronous or | 2 channel each | 1 channel each | 1 channel each | 1 channel each |
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| OutputChannels: | Alternating | Stimulator PodAlternating in oneStimulator Pod | Stimulator Pod | Stimulator device | Stimulator device |
|---|---|---|---|---|---|
| Method ofChannelIsolation | Microprocessorstagger output timeof 2 channels | N/A | N/A | N/A | |
| Regulated Current orRegulated Voltage | Regulated Voltage | Regulated Current | Regulated Current | Regulated Current | |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Yes | Yes | |
| Automatic Overload Trip | No | No | No | Yes | |
| Automatic No-Load Trip | Yes | No | Yes | Yes | |
| Automatic Shut Off | Yes | Yes | Yes | Yes | |
| User Override Control | Yes | Yes | Yes | Yes | |
| IndicatorDisplay: | On/Off Status | Yes | Yes | Yes | Yes |
| Low Battery | Yes | Yes | Yes | Yes | |
| Voltage/CurrentLevel | Yes | Yes | Yes | Yes | |
| Timer Range (minutes) | 5~60 | 5 ~ 60 | 30 | The Livia has nointernal timer asthere is notreatment timelimitation for using |
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| the Livia. | ||||
|---|---|---|---|---|
| Compliance with 21 CFR 898? | Yes | N/A (no patient cable) | N/A (no patient cable) | Yes |
| Weight (g) | Remote Control:44.1g (1.6oz)Stimulator Pod:34.2g (12.1oz)Brace: | Remote Control:60g (2.1oz)Stimulator Pod: 30g (1.1oz) | Device: 55g (1.9oz)Knee pad: 20g (0.7oz)Knee band M: 27g (1.0oz)Knee band L: 29g (1.0oz)Charger: 100g (3.5oz) | 36g (1.3oz) |
| Dimensions (mm) | Remote Control:120 (4.73") x40 (1.58") x12.5 (0.49")Stimulator Pod:$φ$ 61 (2.36") x14.77 (0.58")Brace:461 (18.15") x207 (8.15") | Remote Control:156.98 (6.18") x47 (1.85") x15.50 (0.61")Stimulator Pod:$φ$ 60 (2.36") x15.65 (0.62") | Device:60 (2.36") ×72 (2.83") ×16 (0.63")Charger:90 (3.54") x80 (3.15") ×23.5 (0.93")Knee pad:130 (5.12") ×60 (2.36") ×16 (0.63") | 55 (2.17") x55 (2.17") x18 (0.71") |
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| Knee Band M:385 (15.16") ×64 (2.52")Knee Band L:450 (17.72") ×64 (2.52") | ||||
|---|---|---|---|---|
| Housing Materials andConstruction | PC/ABS plastic | PC/ABS plastic | Not publiclyavailable | PC/ABS plastic |
| Operating conditions | 0 to 40°C (32 to104°F)10 to 90% RH700 to 1060 hPa | 10 to 40°C (50 to104°F)40-90% RH700 to 1013 hPa | 10 to 40°C (50 to104°F)30 to 80 %RH700 to 1060 hPa(noncondensing) | 5 to 40°C (41 to104°F)15 to 93% RH700 to 1060 hPa |
| Storage conditions | -5 to 40°C (23 to104°F)0 to 90% RH | -10 to 60°C (14 to140°F)30-95% RH. | 0 to 40 °C (32 to104°F)30 to 80 % RH(noncondensing) | -25 to 70°C (-13 to158°F)15 to 93% RH |
| Transporting conditions | -5 to 40 °C (23 to104°F)0 to 90% RH | -10 to 60°C (14 to140°F),30-95% RH. | -20 to 60 °C (-4 to140°F)10 to 90 % RH(noncondensing) | -25 to +70°C (-13 to158°F)15 to 93% RH |
| Electrode style | Self-adhesiveReusable | Self-adhesiveReusable | HV-KNPAD-ZReusable | Self-adhesiveReusable |
| Patient Contact Accessory | Yes | Yes | Yes | Yes |
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Table 3. Substantial Equivalence Table – D Comparison
| Subject Device | Primary Predicate | Secondary Predicate | Third Predicate | |
|---|---|---|---|---|
| Trade/Device Name | Wireless ElectricalStimulator (RS-18,RS-28, RS-38) | Well Life WirelessTENS/EMSStimulator, ModelsWR-2605A/2605 | Focus TENSTherapy, ModelPM710-M/-L | Livia |
| 510(k) Number | K220997 | K161453 | K183215 | K183110 |
| Waveform | Biphasic,Symmetrical | Biphasic,Symmetrical | Biphasic,Symmetrical | Biphasic,Symmetrical |
| Shape | Rectangular | Rectangular | Rectangular | Rectangular |
| MaximumOutput Voltage(volts) | @500Ω40@2KΩ40@10kΩ40 | @500Ω40@2KΩ75@10kΩ133.5 | @500Ω45@2KΩ68.6@10kΩ78.5 | @500Ω50@2KΩ64@10kΩ64 |
| MaximumOutput Current(mA) | @500Ω80@2kΩ20@10kΩ4 | @500Ω80@2kΩ37.5@10kΩ1.34 | @500Ω90@2kΩ34.3@10kΩ7.9 | @500Ω50@2kΩ31@10kΩ6.4 |
| Pulse Width (usec) | 40-400 | 100-520 | 60 | 100 |
| Frequency (Hz) | 1-150 | 2-60 | 1-250 | 100 |
| Formultiphasicwaveformsonly: | SymmetricalphasesPhaseDuration(µsec) | Yes | N/A | Yes |
| Net Charge(µC per pulse)(@500Ω) (uC) | 0 | 0 | 0 | 0 |
| Maximum Phase Charge | 16 | 20.8 | 5.4 | 6.4 |
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| (@500Ω) (μC) | Maximum Current Density(@500Ω) (mA/cm²) r.m.s. | Maximum Average Current(average absolute value),(mA) | Maximum Average PowerDensity (@500Ω) (W/cm²) | Burst Mode | Electrical Safety & EMC | Biocompatibility |
|---|---|---|---|---|---|---|
| 0.96 | 4.8 | 9.4E-03 | (a) Pulses perburst | IEC 60601-1, IEC60601-1-2, IEC60601-2-10, IEC60601-1-11 | ISO 10993-1ISO 10993-5ISO 10993-10 | |
| 0.25 | 2.496 | 1.76E-03 | (b) Bursts persecond | ES 60601-1,IEC60601-1-2,IEC60601-2-10, IEC60601-1-11 | Not publiclyavailable | |
| 0.97 | 2.7 | 7.59E-03 | (c) Burstduration | ES 60601-1,IEC60601-1-2,IEC60601-2-10, IEC60601-1-11 | Not publiclyavailable | |
| 0.38 | 1.19 | 2.05E-03 | (d) Duty cycle:Line(b) x Line(c) | IEC 60601-1, IEC60601-1-2, IEC60601-2-10 | ISO 10993-5ISO 10993-10 | |
| ON Time (seconds) N/A | N/A | |||||
| OFF Time (seconds) N/A | N/A | |||||
| Additional Features N/A | N/A |
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| Subject Device | Predicate /Reference Device | ||||||
|---|---|---|---|---|---|---|---|
| Program | PulseWidth(us) | Frequency(Hz) | Trade/DeviceName | 510(k)Number | Program | PulseWidth(us) | Frequency(Hz) |
| Acute Pain | 175 | 2, 4 | DJOPrimera | K153224 | P03 | 175 | 2 |
| ChronicPain | 210 | 2/10/20/40/80 | Well-Life | K161453 | TENS-P8 | 210 | 2.45~245 |
| Soreness | 200 | 150 | DJOPrimera | K153224 | P04 | 200 | 150 |
| Back Pain | 250/150 | 2/70 | DJOPrimera | K153224 | HAN | 250/150 | 2/70 |
| MenstrualCramping | 100 | 100 | Livia | K183110 | N/A | 100 | 100 |
| Arthritis | 210 | 2.45~245 | Well-Life | K161453 | TENS-P8 | 210 | 2.45~245 |
| Warm-up | 200 | 12 | DJOPrimera | K153224 | P10 | 200 | 12 |
| Recovery | 220 | 10/8/6/4/2/1 | PowerDot | K172876 | ActiveRecovery | 200 | 10/8/6/4/2/1 |
| Atrophy | 250 | 50/1 | Cefar | K020803 | P10 | 250 | 50/1 |
| Strength | 400 | 85/100 | PowerDot | K172876 | Strength | 400 | 75~100 |
| Endurance | 300 | 5/10/15/20 | PowerDot | K172876 | Endurance | 300 | 10~25 |
| Resistance | 300 | 35/50 | PowerDot | K172876 | ResistanceI & II | 300 | 35/50 |
| Comfort | 220 | 7/5/3/1 | PowerDot | K172876 | General | 200 | 7/5/3/1 |
| Kneading | 300 | 40-99 | Well-Life | K161453 | EMS-P1 | 300 | 40-99 |
| Tingling | 200/100 | 65/100 | DJOPrimera | K153224 | P06 | 200/100 | 65/100 |
| Tapping | 300 | 5 | Well-Life | K161453 | EMS-P3 | 300 | 5 |
Table 4. Comparison of Programs
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| Relaxation | 200 | 12 | DJO Primera | K153224 | P08 | 200 | 12 |
|---|---|---|---|---|---|---|---|
| Alternating | 70/180 | 80 | Cefar | K020803 | P7 | 70/180 | 80 |
Based on the comparison of indications for use (Table 1), all subject device and primary predicate devices (Well Life Wireless TENS/EMS K161453) have the same intended use on TENS and EMS. Subject device and third predicate (Livia K183110) both have the indications for use for temporary relief of pain associated with dysmenorrhea. And subject device also has the same environments of use and patient population as secondary predicate (Focus TENS K183215).
From the technical characteristics (Table 2) and technical characteristics comparison (Table 3), the following conclusions can be drawn. Although there are some differences in mechanical, environmental conditions, and output specifications among the subject device and the predicate devices, the subject device complies with a range of FDA- Recognized consensus standards and guidelines. This demonstrates that these differences do not raise any new questions about safety or efficacy.
Performance Data
The following performance data are provided to substantial equivalence determination.
Non-clinical Testing
A series of safety and performance tests, as follows, were conducted on the subject device in accordance with FDA recognized consensus standards and/or guidance:
Biocompatibility testing
The biocompatibility evaluation for the "Wireless Electrical Stimulator" was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,", and International Standard ISO 10993-1 as recognized by FDA. The self-adhesive reusable electrode for "Wireless Electrical Stimulator" is identical to the reference device (ZMI Self-Adhesive Electrodes K180865). The brace was tested for the following:
- ISO 10993-5 Cytotoxicity ●
- . ISO 10993-10 Sensitization & Irritation
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the "Wireless Electrical Stimulator". The system complies with the IEC 60601-1, IEC 60601-1-11 and IEC 60601-2-10 standards for safety and the IEC 60601-1-2 standard for EMC. The stimulation function test has also been conducted to verify the output specifications of the device according to "Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use and Guidance for Powered Muscle Stimulator for Muscle Conditioning".
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Software Verification and Validation Testing
Software verification and validation testing were conducted and documented which provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" The software for this device was considered as a "Moderate" level of concern, since a failure in the software could result in minor injury to the patient or operator.
Human Factor and Usability Testing
Usability test were conducted and documented according to the recognized consensus standards of IEC 62366-1. The result of the usability demonstrated all the users in testing did not show any critical errors and represented the performance of using can be smoother by extra practices without specific usability problems. The "Wireless Electrical Stimulator" has been found to be reasonably safe and effective for the intended users, uses and use environments.
Performance Bench Testing (Devices)
To make sure the device has met the intended functions and specifications, the function performance tests had proven the Remote Control and Stimulator (or Receiver) Pod of "Wireless Electrical Stimulator" is safe and effective for the intended users, uses and use environments.
Performance Bench Testing (Electrode)
AC Impedance, Current Dispersion, Retention Force Test, and Reusability Test proof the Self-Adhesive Electrode for "Wireless Electrical Stimulator" is identical to and even better than the Referencing Device. The results also indicating that the electrodes are safe and effective for the intended users, uses and use environments.
Mechanical and Stability Testing
- Button reliability testing ●
- . Lead wire connector and bending life testing
- Drop/Vibration Testing .
- . Temperature and humidity cycle test
- Device life test .
By conducting those mechanical and stability test, the result shown that the device can work well during the whole service life and being safe and effective for the intended users, uses and use environments.
Clinical Studies
Not applicable. Clinical testing was not performed to support this 510(k) submission.
Conclusions
The information submitted to the "Wireless Electrical Stimulator" does not raise new questions about safety or effectiveness and demonstrates with reasonable assurance based on established controls that the device is as safe and effective as a legally marketed device.
§ 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).