(93 days)
HIVOX OTC Electrical Stimulator, EM59-1
TENS: This function is designated to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
SH: This function is designed to be used for temporary relief of minor aches and pains.
HIVOX OTC Electrical Stimulator, EM59-2
TENS: This function is designated to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
EMS: This function is designed to be used for stimulating healthy muscles in order to improve and facilitate muscle performance.
SH: This function is designed to be used for temporary relief of minor aches and pains.
HIVOX OTC Electrical Stimulators, EM59-1 and EM59-2, fall into the electrostimulation device category.
EM59-1 provides two basic functions, TENS and SH; EM59-2 provides three basic functions, TENS, EMS and SH:
(1) Electrical stimulation of nerve tracts (TENS)
(2) Electrical stimulation of muscle tissue (EMS)
(3) Superficial heat (SH)
Both two models feature two independent output channels and four self-adhesive electrode gel pads. They offer a wide range of functions for increasing general wellbeing, pain relief, maintaining physical fitness, relaxation, muscle revitalisation and combating tiredness. For these purpose, the user can either choose from pre-set programs or specify their own to suit the user's individual needs.
The size of the self-adhesive electrode gel pad is 45x45 mm supplied by Shaoxing DL Healthcare Co., Ltd. It is an OTC medical device cleared by FDA under K182111. On the other hand, the electrode made by PET, sponge, PCB and protect cases is designed by HIVOX BIOTEK INC.
The provided text describes the 510(k) summary for the HIVOX OTC Electrical Stimulator (EM59-1, EM59-2). This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. It does not contain information about acceptance criteria and studies demonstrating device performance for an AI/ML powered device, as the device described is an electrical stimulator, not an AI/ML product.
Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types) because it is not present in the provided document.
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March 10, 2021
Hivox Biotek Inc. Ruby Lu Regulatory Affairs Specialist 5F, No. 123, Xingde Road, Sanchong District, New Taipei City, 241 Taiwan
Re: K203574
Trade/Device Name: HIVOX OTC Electrical Stimulator, EM59-1, HIVOX OTC Electrical Stimulator, EM59-2 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX, IRT Dated: November 30, 2020 Received: December 7, 2020
Dear Ruby Lu:
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
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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,
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K203574
Device Name
HIVOX OTC Electrical Stimulator (EM59-1, EM59-2)
Indications for Use (Describe)
HIVOX OTC Electrical Stimulator, EM59-1
TENS: This function is designated to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
SH: This function is designed to be used for temporary relief of minor aches and pains.
HIVOX OTC Electrical Stimulator, EM59-2
TENS: This function is designated to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (leg) due to strain from exercise or normal household work activities.
EMS: This function is designed to be used for stimulating healthy muscles in order to improve and facilitate muscle performance.
SH: This function is designed to be used for temporary relief of minor aches and pains.
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
| 1. Type of Submission | Traditional |
|---|---|
| 510(k) Number | K203574 |
| 2. Date of Summary | Mar. 2, 2021 |
| 3. Submitter | HIVOX BIOTEK INC. |
| Address: | 5F., No. 123, Xingde Rd., Sanchong Dist., New |
| Taipei City 24158, Taiwan, R.O.C. | |
| Phone: | +886-2-8511-2668 |
| Fax: | +886-2-8511-2669 |
| Contact: | Ruby Lu |
| (Ruby.Lu@hivox-biotek.com) |
4. Identification of the Subject Device
| 510(k) number | K203574 |
|---|---|
| Proprietary/Trade name: | HIVOX OTC Electrical Stimulator |
| Models: | EM59-1, EM59-2 |
| Classification product code: | NUH |
| Subsequent product code: | NGX, IRT |
| Regulation number: | 1) 882.5890 |
| 2) 890.5850 | |
| 3) 890.5740 | |
| Regulation description: | 1) Transcutaneous electrical nerve stimulator forpain relief |
| 2) Powered muscle stimulator | |
| 3) Power heating pad | |
| Review panel: | 1) Neurology |
| 2) Physical Medicine | |
| 3) Physical Medicine | |
| Device class: | II |
5. Identification of the Predicate Device #1
| 510(k) number: | K162517 |
|---|---|
| Proprietary/Trade name: | Electrical Pulse Stimulator |
| Models: | PL-029K13 |
| Classification product code: | NUH, NGX, NYN, IRT |
| Regulation number: | 882.5890 |
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| Regulation description: | Transcutaneous electrical nerve stimulator for painrelief |
|---|---|
| Review panel: | Neurology |
| Device class: | II |
6. Identification of the Predicate Device #2
| 510(k) number: | K190347 |
|---|---|
| Proprietary/Trade name: | HIVOX OTC Electrical Stimulator |
| Models: | EM49-1, EM49-2 |
| Classification product code: | NUH |
| Subsequent product code: | NGX |
| Regulation number: | 1) 882.5890 |
| 2) 890.5850 | |
| Regulation description: | 1) Transcutaneous electrical nerve stimulator forpain relief |
| 2) Powered muscle stimulator | |
| Review panel: | 1) Neurology |
| 2) Physical Medicine | |
| Device class: | II |
7. Intended Use / Indications for Use of the Device
HIVOX OTC Electrical Stimulator, EM59-1
TENS: This function is designated to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
SH: This function is designed to be used for temporary relief of minor aches and pains.
HIVOX OTC Electrical Stimulator, EM59-2
TENS: This function is designated to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg)due to strain from exercise or normal household work activities.
EMS: This function is designed to be used for stimulating healthy muscles in order to improve and facilitate muscle performance.
SH: This function is designed to be used for temporary relief of minor aches and pains.
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8. Device Description
HIVOX OTC Electrical Stimulators, EM59-1 and EM59-2, fall into the
electrostimulation device category.
EM59-1 provides two basic functions, TENS and SH; EM59-2 provides three basic functions, TENS, EMS and SH:
(1) Electrical stimulation of nerve tracts (TENS)
(2) Electrical stimulation of muscle tissue (EMS)
(3) Superficial heat (SH)
Both two models feature two independent output channels and four self-adhesive electrode gel pads. They offer a wide range of functions for increasing general wellbeing, pain relief, maintaining physical fitness, relaxation, muscle revitalisation and combating tiredness. For these purpose, the user can either choose from pre-set programs or specify their own to suit the user's individual needs.
The size of the self-adhesive electrode gel pad is 45x45 mm supplied by Shaoxing DL Healthcare Co., Ltd. It is an OTC medical device cleared by FDA under K182111. On the other hand, the electrode made by PET, sponge, PCB and protect cases is designed by HIVOX BIOTEK INC.
9. 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:
- Shelf life (ASTM F1980-16)
- Biocompatibility (ISO 10993-1 Edition 4.0, ISO 10993-5 Edition 3.0 and ISO 10993-10 Edition 3.0)
- Software validation (IEC 62304 Edition 1.1)
- Electromagnetic compatibility and electrical safety (ANSI/AAMI ES60601-1:2015/(R)2012, IEC 60601-1-2 Edition 4.0, IEC 60601-1-11 Edition 2.0 and IEC 60601-2-10 Edition 2.1)
- Function test (Guidance Document for Powered Muscle Stimulator 510(K)s. Document issued on: June 9, 1999)
- Usability test (IEC 60601-1-6 Edition 3.1 and IEC 62366-1 Edition 1.0)
All the test results demonstrate the subject device, HIVOX OTC Electrical Stimulator (EM59-1, EM59-2), meets the requirements of its pre-defined acceptance criteria and intended use, and its substantially equivalent to the predicate device.
10. Clinical Testing
No clinical test data was used to support the decision of substantial equivalence.
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11. Substantial Equivalence Comparison
The subject device, HIVOX OTC Electrical Stimulator (EM59-1, EM59-2), was compared to a predicate device and reference device respectively in the tables below:
| Comparison item | Subject device | Predicate device #1 | |
|---|---|---|---|
| 510(k) Number | K203574 | K162517 | |
| Device Name | HIVOX OTC ElectricalStimulator | Electronic PulseStimulator | |
| Model | EM59-1 | EM59-2 | PL-029K13 |
| Manufacturer | HIVOX BIOTEK INC. | JKH Health Co., Ltd. | |
| Intended Use | EM59-1:TENS: This function isdesigned to be used fortemporary relief of painassociated with sore andaching muscles in theshoulder, waist, back,upper extremities (arm)and lower extremities(leg) due to strain fromexercise or normalhousehold work activities.SH: This function isdesigned to be used fortemporary relief of minoraches and pains.EM59-2:TENS: This function isdesigned to be used fortemporary relief of painassociated with sore andaching muscles in theshoulder, waist, back,upper extremities (arm) | TENS ModeTo be used for temporaryrelief of pain associatedwith sore and achingmuscles in the shoulder,waist, back, arm and legdue to strain from exerciseor normal household andwork activities.It is also intended forsymptomatic relief andmanagement of chronic,intractable pain and reliefof pain associated witharthritis.PMS ModeTo stimulate healthymuscles in order toimprove and facilitatemuscle performance. Tobe used for theimprovement of muscletone and firmness, and forstrengthening muscles inthe arm, abdomen, legs, | |
| Prescription or OTC | OTC | OTC | |
| FDA Product Code | NUH, NGX, IRT | NUH, NGX, NYN, IRT | |
| Power Source(s) | Rechargeable battery | Rechargeable battery | |
| Function and Design | Electrical stimulation and heat | Electrical stimulation and heat | |
| Heating Setting | |||
| Maximum Temperature Setting | 43°C | 43°C | |
| Maximum | @ 500 Ω | 50.0 | 46.0 |
| Output Voltage | @ 2 kΩ | 90.0 | 90.4 |
| (Vp, ±20%) | @ 10 kΩ | 125 | 124 |
| Maximum | @ 500 Ω | 100 | 92.0 |
| Output Current | @ 2 kΩ | 45.0 | 45.2 |
| (mAp, ±20%) | @ 10 kΩ | 12.5 | 12.4 |
| Pulse Period (µs) | 50 to 450 | 5.6 to 806 | |
| Frequency (Hz) | 1 to 150 | 1.24 to 178.5 | |
| Maximum Phase Charge(µC @ 500Ω) | 45 | 16.9 | |
| Maximum Current Density(mA/cm² @ 500Ω) | 0.667 | 3.29 | |
| Maximum Power Density | 0.0046 | 0.00165 | |
| (W/cm² @ 500Ω) | |||
| Output Patterns | ● Electrical stimulationonly● Heat only● Electrical stimulation+ Heat simultaneously | ● Electrical stimulationonly● Heat only● Electrical stimulation+ Heat simultaneously |
Table 1 - Comparison to Predicate Device #1
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Table 2 – Comparison to Predicate Device #2
| Comparison item | Subject device | Predicate device #2 | |
|---|---|---|---|
| 510(k) Number | K203574 | K190347 | |
| Device Name | HIVOX OTC ElectricalStimulator | HIVOX OTC ElectricalStimulator | |
| Model | EM59-1 EM59-2 | EM49-1 EM49-2 | |
| Manufacturer | HIVOX BIOTEK INC. | HIVOX BIOTEK INC. | |
| Intended use | EM59-1:TENS: This function isdesigned to be used fortemporary relief of painassociated with sore andaching muscles in theshoulder, waist, back,upper extremities (arm)and lower extremities(leg) due to strain fromexercise or normalhousehold work activities.SH: This function isdesigned to be used fortemporary relief of minoraches and pains.EM59-2:TENS: This function isdesigned to be used fortemporary relief of painassociated with sore and | EM49-1:TENS: This device isdesigned to be used fortemporary relief of painassociated with sore andaching muscles in theshoulder, waist, back,neck, upper extremities,lower extremities,abdomen and bottom dueto strain from exercise ornormal household workactivities.EM49-2:TENS: This device isdesigned to be used fortemporary relief of painassociated with sore andaching muscles in theshoulder, waist, back,neck, upper extremities,lower extremities, | |
| aching muscles in theshoulder, waist, back,upper extremities (arm)and lower extremities(leg) due to strain fromexercise or normalhousehold work activities.EMS: This function isdesigned to be used forstimulating healthymuscles in order toimprove and facilitatemuscle performance.SH: This function isdesigned to be used fortemporary relief of minoraches and pains. | abdomen and bottom dueto strain from exercise ornormal household workactivities.EMS: This device isdesigned to be used forstimulating healthymuscles in order toimprove and facilitatemuscle performance. | ||
| Prescription or OTC | OTC | OTC | |
| FDA product code | NUH, NGX, IRT | NUH, NGX | |
| Power Source(s) | Battery powered, d.c.3.7 V, 1 × built-inrechargeable lithium-ionbattery | Battery powered, d.c.4.5 V, 3 × AAA batteries | |
| Method of Line CurrentIsolation | N/A(internal power source) | N/A(internal power source) | |
| PatientLeakageCurrent | Normalcondition(μΑ) | 6.0 | 6.0 |
| Single faultcondition(μΑ) | 5.6 | 5.6 | |
| Number of Output Modes | TENS: 15SH: 1 | TENS: 15EMS: 35SH: 1 | |
| Number ofoutputChannels | SynchronousorAlternating? | 2 Synchronous | 2 Synchronous |
| Method ofChannelIsolation | By electrical circuit andsoftware | By electrical circuit andsoftware | |
| Regulated Current orRegulated Voltage? | Regulated current | Regulated current | |
| Software/Firmware/Microprocessor Control? | Yes | Yes | |
| Automatic Overload Trip? | Yes | Yes | |
| Automatic No-Load Trip? | Yes | Yes | |
| Automatic Shut Off? | Yes | Yes | |
| Patient Override Control? | Yes | Yes | |
| On/Off Status? | Yes | Yes | |
| IndicatorDisplay | Low Battery? | Yes | Yes |
| Voltage/CurrentLevel? | Yes | Yes | |
| Timer Range(minute) | 5 to 100 minutesadjustable | 5 to 100 minutesadjustable | |
| Compliant with VoluntaryStandards? | ES60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-10 | ES60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-10 | |
| Compliant with21 CFR 898? | Yes | Yes | |
| Weight (g) | Approx. 125(including belt clip andbattery) | Approx. 117(including belt clip andbatteries) | |
| Dimensions (mm)[W × H × D] | Approx.139 × 66 × 26(including belt clip) | Approx.132 × 63 × 29.5(including belt clip) | |
| Housing Materials andConstruction | Plastic (ABS) enclosure | Plastic (ABS) enclosure | |
| Waveform | Biphasic | Biphasic | |
| Shape | Rectangular | Rectangular | |
| MaximumOutput Voltage(Vp-p, ±10%) | @ 500Ω | 100 | 100 |
| @ 2 kΩ | 180 | 180 | |
| @ 10 kΩ | 250 | 250 | |
| MaximumOutput Current(mAp-p, ±10%) | @ 500Ω | 200 | 200 |
| @ 2 kΩ | 90 | 90 | |
| @ 10 kΩ | 25 | 25 | |
| Pulse Width (µs) | 50 to 450 | 50 to 450 | |
| Frequency (Hz) | 1 to 150 | 1 to 150 | |
| For interferential modesonly: | N/A | N/A | |
| - | Beat Frequency (Hz) | N/A | N/A |
| Formultiphasicwaveformsonly: | Symmetricalphases?PhaseDuration | N/A | N/A |
| Net Charge( $\mu$ C per pulse @ 500Ω) | 0 | 0 | |
| Maximum Phase Charge( $\mu$ C @ 500Ω) | 45 | 45 | |
| Maximum Average Current(mA @ 500Ω) | 13.5 | 13.5 | |
| Electrode ConductiveSurface Area (cm²) | 20.25 | 20.25 | |
| Maximum Current Density(mA/cm² @ 500Ω) | 0.667 | 0.667 | |
| Maximum Power Density(W/cm² @ 500Ω) | 0.0046 | 0.0046 | |
| Output Intensity | TENS: Level 0 to 50EMS: Level 0 to 50SH: Level LOW and HI | TENS: Level 0 to 50EMS: Level 0 to 50 | |
| Heating Level (°C) | Level LOW: up to 41Level HI: up to 43 | N/A | |
| Operating Condition | Temperature:5°C to 40°C | Temperature:5°C to 40°C | |
| Humidity: | Humidity: | ||
| 15% RH to 90% RH | 15% RH to 90% RH | ||
| Storage Condition | Temperature:0°C to 40°C | Temperature:0°C to 40°C | |
| Humidity:0% RH to 90% RH | Humidity:0% RH to 90% RH | ||
| Use Altitude Limit (m) | 3000 | 3000 | |
| Use Atmospheric Pressure(hPa) | 700 to 1060 | 700 to 1060 |
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12. Similarity and Difference
Based on the comparison information in our submission, we can determine that the subject devices almost identical to the predicate devices #2 in all aspect, except it add a SH function. On the other hand, the subject devices have the same intended use and provide the same functions by the same operating principle as the predicate device #1, except the predicate device #1 includes an additional intended use for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. Although there are still several specifications different between the subject devices and predicate devices, the subject devices have undergone and passed a series of safety tests complied with the specific FDA-recognized consensus standards to demonstrate these differences would not adversely impact the safety and effectiveness of the subject device. Therefore, the differences between the subject devices and the predicate devices would not raise any problem in substantial equivalence claims.
13. Conclusion
After analyzing a series of non-clinical test results we have ensure that all of our design outputs meet the specified requirements of inputs, and also the final product meets the user needs. Thus, we can reasonably believe that the subject device, HIVOX OTC Electrical Stimulator (EM59-1, EM59-2), is substantially equivalent to the predicate devices in safety and effectiveness.
§ 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).