(93 days)
Not Found
No
The document describes a standard electrical stimulator with pre-set and user-defined programs, but there is no mention of AI or ML capabilities for adapting treatment or analyzing data.
Yes
The device is described as an "OTC Electrical Stimulator" and its intended use includes "temporary relief of pain associated with sore and aching muscles" and "temporary relief of minor aches and pains," which are therapeutic claims. It also mentions "stimulating healthy muscles in order to improve and facilitate muscle performance."
No
The device is described as an electrostimulation device for temporary relief of pain and stimulating muscles; it does not mention diagnosing conditions.
No
The device description explicitly mentions hardware components such as two independent output channels, four self-adhesive electrode gel pads, and electrodes made of PET, sponge, PCB, and protect cases. The performance studies also include tests related to hardware safety and performance (e.g., electromagnetic compatibility, electrical safety, function test).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The HIVOX OTC Electrical Stimulator (EM59-1 and EM59-2) is an electrostimulation device that applies electrical currents and heat directly to the body's surface. It is used for pain relief and muscle stimulation.
- Intended Use: The intended use clearly states it's for temporary relief of pain and stimulating muscles. This involves direct interaction with the body, not the analysis of in vitro specimens.
- Device Description: The description details the functions (TENS, EMS, SH) and components (electrodes) which are all related to external application to the body.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, laboratory procedures, or diagnostic purposes related to analyzing specimens.
Therefore, the HIVOX OTC Electrical Stimulator is a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NUH, NGX, IRT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, waist, back, upper extremities (arm), lower extremities (leg)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing: A series of safety and performance tests were conducted on the subject device in accordance with FDA recognized consensus standards and/or guidance. These included: 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), and Usability test (IEC 60601-1-6 Edition 3.1 and IEC 62366-1 Edition 1.0).
Key results: 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.
Clinical Testing: No clinical test data was used to support the decision of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
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
2
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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3
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 for |
| pain 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 |
4
| Regulation description: | Transcutaneous electrical nerve stimulator for pain
relief |
|-------------------------|---------------------------------------------------------------|
| 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 for |
| pain 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.
5
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.
6
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 Electrical | ||
| Stimulator | Electronic Pulse | ||
| Stimulator | |||
| Model | EM59-1 | EM59-2 | PL-029K13 |
| Manufacturer | HIVOX BIOTEK INC. | JKH Health Co., Ltd. | |
| Intended Use | EM59-1: | ||
| TENS: This function is | |||
| designed 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. | |||
| EM59-2: | |||
| TENS: This function is | |||
| designed to be used for | |||
| temporary relief of pain | |||
| associated with sore and | |||
| aching muscles in the | |||
| shoulder, waist, back, | |||
| upper extremities (arm) | TENS Mode | ||
| 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. | |||
| It is also intended for | |||
| symptomatic relief and | |||
| management of chronic, | |||
| intractable pain and relief | |||
| of pain associated with | |||
| arthritis. | |||
| PMS Mode | |||
| To stimulate healthy | |||
| muscles in order to | |||
| improve and facilitate | |||
| muscle performance. To | |||
| be used for the | |||
| improvement of muscle | |||
| tone and firmness, and for | |||
| strengthening muscles in | |||
| the 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 stimulation | ||
| only | |||
| ● Heat only | |||
| ● Electrical stimulation |
- Heat simultaneously | ● Electrical stimulation
only
● Heat only
● Electrical stimulation - Heat simultaneously | |
Table 1 - Comparison to Predicate Device #1
7
8
Table 2 – Comparison to Predicate Device #2
| Comparison item | Subject device | Predicate device #2 | |
|---|---|---|---|
| 510(k) Number | K203574 | K190347 | |
| Device Name | HIVOX OTC Electrical | ||
| Stimulator | HIVOX OTC Electrical | ||
| Stimulator | |||
| Model | EM59-1 EM59-2 | EM49-1 EM49-2 | |
| Manufacturer | HIVOX BIOTEK INC. | HIVOX BIOTEK INC. | |
| Intended use | EM59-1: | ||
| TENS: This function is | |||
| designed 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. | |||
| EM59-2: | |||
| TENS: This function is | |||
| designed to be used for | |||
| temporary relief of pain | |||
| associated with sore and | EM49-1: | ||
| TENS: This device is | |||
| designed to be used for | |||
| temporary relief of pain | |||
| associated with sore and | |||
| aching muscles in the | |||
| shoulder, waist, back, | |||
| neck, upper extremities, | |||
| lower extremities, | |||
| abdomen and bottom due | |||
| to strain from exercise or | |||
| normal household work | |||
| activities. | |||
| EM49-2: | |||
| TENS: This device is | |||
| designed to be used for | |||
| temporary relief of pain | |||
| associated with sore and | |||
| aching muscles in the | |||
| shoulder, waist, back, | |||
| neck, upper extremities, | |||
| lower extremities, | |||
| 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. | abdomen and bottom due
to strain from exercise or
normal household work
activities.
EMS: This device is
designed to be used for
stimulating healthy
muscles in order to
improve and facilitate
muscle 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-in
rechargeable lithium-ion
battery | Battery powered, d.c.
4.5 V, 3 × AAA batteries | |
| Method of Line Current
Isolation | N/A
(internal power source) | N/A
(internal power source) | |
| Patient
Leakage
Current | Normal
condition
(μΑ) | 6.0 | 6.0 |
| | Single fault
condition
(μΑ) | 5.6 | 5.6 |
| Number of Output Modes | | TENS: 15
SH: 1 | TENS: 15
EMS: 35
SH: 1 |
| | | | |
| Number of
output
Channels | Synchronous
or
Alternating? | 2 Synchronous | 2 Synchronous |
| | Method of
Channel
Isolation | By electrical circuit and
software | By electrical circuit and
software |
| Regulated Current or
Regulated Voltage? | | Regulated current | Regulated current |
| Software/Firmware/Micropr
ocessor 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 |
| Indicator
Display | Low Battery? | Yes | Yes |
| | Voltage/Current
Level? | Yes | Yes |
| Timer Range
(minute) | | 5 to 100 minutes
adjustable | 5 to 100 minutes
adjustable |
| Compliant with Voluntary
Standards? | | ES60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-10 | ES60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-10 |
| Compliant with
21 CFR 898? | | Yes | Yes |
| Weight (g) | | Approx. 125
(including belt clip and
battery) | Approx. 117
(including belt clip and
batteries) |
| Dimensions (mm)
[W × H × D] | | Approx.
139 × 66 × 26
(including belt clip) | Approx.
132 × 63 × 29.5
(including belt clip) |
| Housing Materials and
Construction | | Plastic (ABS) enclosure | Plastic (ABS) enclosure |
| Waveform | | Biphasic | Biphasic |
| Shape | | Rectangular | Rectangular |
| | | | |
| Maximum
Output Voltage
(Vp-p, ±10%) | @ 500Ω | 100 | 100 |
| | @ 2 kΩ | 180 | 180 |
| | @ 10 kΩ | 250 | 250 |
| Maximum
Output 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 modes
only: | N/A | N/A |
| - | Beat Frequency (Hz) | N/A | N/A |
| For
multiphasic
waveforms
only: | Symmetrical
phases?
Phase
Duration | 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 Conductive
Surface 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 50
EMS: Level 0 to 50
SH: Level LOW and HI | TENS: Level 0 to 50
EMS: Level 0 to 50 |
| Heating Level (°C) | | Level LOW: up to 41
Level 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 | |
9
10
11
12
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.