(162 days)
No
The summary describes a standard TENS device with a heat function and adjustable intensity levels. There is no mention of AI, ML, image processing, or any data-driven decision-making or learning capabilities. The performance studies focus on standard safety and electrical performance, not algorithmic validation.
Yes
The device is a Transcutaneous Electrical Nerve Stimulation (TENS) device combined with a heat function, intended for symptomatic relief and management of chronic pain, temporary relief of pain associated with sore and aching muscles, and dysmenorrhea. These indications directly relate to treating and alleviating medical conditions or symptoms, which defines its role as a therapeutic device.
No
The device is described as a TENS device for symptomatic relief and management of pain. It does not mention any function for diagnosing conditions.
No
The device description explicitly states it is a "self-adhesive TENS device" and mentions "electrical stimulation of nerves through the skin" via "gel pads," indicating it is a hardware device that delivers electrical current. The software validation mentioned in the performance studies refers to the software controlling this hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for symptomatic relief and management of pain, and temporary relief of pain associated with various conditions. This involves applying electrical stimulation and heat to the body.
- Device Description: The description details a TENS device that delivers electrical currents through the skin and provides heat. This is a physical therapy modality, not a diagnostic test performed on samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions based on such analysis, or providing information for diagnosis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The FT610-B is designed for symptomatic relief and management of chronic pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities and lower extremities due to strain from exercise or normal household work activities. It is also indicated for temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication, it also provides a heat function intended to temporarily relieve minor aches and pains.
Product codes (comma separated list FDA assigned to the subject device)
NUH
Device Description
The subject device is a self-adhesive TENS device with 15 adjustable intensity levels for pain relief. Moreover, it also provides a heat function which can be used alone, or in conjunction with the TENS function simultaneously. TENS, Transcutaneous Electrical Nerve Stimulation, refers to the electrical stimulation of nerves through the skin which is an effective method of pain relief. It can be used for self-treatment. Any symptoms that could be relieved using TENS must be checked by your general practitioner who will also give you instruction on how to carry out a TENS selftreatment regime.
TENS device works by passing electrical currents over the skin via a set of gel pads. As a transfer medium, the gel pads are subject to natural wear and tear, and must be replaced when they stop providing sufficient contact or the main unit no longer sticks to the skin completely. Failure to replace the gel pad may lead to skin irritation as a result of heightened current density in particular areas.
This device is only compatible with the 50 mm x 56 mm gel pads which are the OTC medical device cleared by FDA under K132588, and come with the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, waist, back, neck, upper extremities and lower extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
self-treatment / normal household work activities
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)
A series of safety and performance tests 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 (FT610-B), meets the requirements of its pre-defined acceptance criteria and intended use, and its substantially equivalent to the predicate device.
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.
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 15, 2021
Hivox Biotek Inc. Ruby Lu Regulatory Affairs Specialist SF., No. 123, Xingde Road, Sanchong District New Taipei City, 241 Taiwan
Re: K211403
Trade/Device Name: HIVOX OTC Electrical Stimulator, FT610-B Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: July 16, 2021 Received: July 19, 2021
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 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
1
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 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
2
Indications for Use
510(k) Number (if known) K211403
Device Name HIVOX OTC Electrical Stimulator (FT610-B)
Indications for Use (Describe)
The FT610-B is designed for symptomatic relief and management of chronic pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities and lower extremities due to strain from exercise or normal household work activities. It is also indicated for temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication, it also provides a heat function intended to temporarily relieve 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY
1. Type of Submission Traditional
| 2. Date of Summary | October 15, 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
| Proprietary Name: | HIVOX OTC Electrical Stimulator |
|---|---|
| Model: | FT610-B |
| Regulation Description: | Transcutaneous electrical nerve stimulator for pain relief |
| Product Code: | NUH |
| Regulation Number: | 21 CFR 882.5890 |
| Device Class: | II |
5. Identification of the Predicate Device #1
| 510(k) Number: | K162517 |
|---|---|
| Manufacturer: | JKH Health Co., Ltd. |
| Proprietary Name: | Electronic Pulse Stimulator |
| Model: | PL-029K13 |
| Regulatory Description: | Transcutaneous electrical nerve stimulator for pain relief |
| Product Code: | NUH, NGX, NYN, IRT |
| Regulatory Number: | 21 CFR 882.5890 |
| Device Class: | II |
6. Identification of the Reference Device
| 510(k) Number: | K183110 |
|---|---|
| Manufacturer: | LifeCare Ltd. |
| Proprietary Name: | LIVIA |
| Regulatory Description: | Transcutaneous electrical nerve stimulator for pain relief |
| Product Code: | NUH |
| Regulatory Number: | 21 CFR 882.5890 |
4
Device Class: II
7. Device Description
The subject device is a self-adhesive TENS device with 15 adjustable intensity levels for pain relief. Moreover, it also provides a heat function which can be used alone, or in conjunction with the TENS function simultaneously. TENS, Transcutaneous Electrical Nerve Stimulation, refers to the electrical stimulation of nerves through the skin which is an effective method of pain relief. It can be used for self-treatment. Any symptoms that could be relieved using TENS must be checked by your general practitioner who will also give you instruction on how to carry out a TENS selftreatment regime.
TENS device works by passing electrical currents over the skin via a set of gel pads. As a transfer medium, the gel pads are subject to natural wear and tear, and must be replaced when they stop providing sufficient contact or the main unit no longer sticks to the skin completely. Failure to replace the gel pad may lead to skin irritation as a result of heightened current density in particular areas.
This device is only compatible with the 50 mm x 56 mm gel pads which are the OTC medical device cleared by FDA under K132588, and come with the device.
8. Intended Use / Indications for Use of the Device
The subject device is designed for symptomatic relief and management of chronic pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities and lower extremities due to strain from exercise or normal household work activities. It is also indicated for temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-thecounter pain medication. In addition, it also provides a heat function intended to temporarily relieve minor aches and pains.
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)
5
- 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 (FT610-B), 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.
11. Substantial Equivalence Comparison
The subject device, HIVOX OTC Electrical Stimulator (FT610-B), was compared to the predicate and reference devices in the tables below:
| Comparison item | Subject device | Primary Predicate | Reference Device | Substantial
Equivalence
Determination | |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| 510(k) Number | To be assigned | K162517 | K183110 | | |
| Device Name | HIVOX OTC
Electrical Stimulator | Electronic Pulse
Stimulator | LIVIA | N/A | |
| Model | FT610-B | PL-029K13 | | | |
| Manufacturer | HIVOX BIOTEK
INC. | JKH Health Co., Ltd | LifeCare Ltd. | | |
| Intended use | The FT610-B is
designed for
symptomatic relief and
management of chronic
pain, and for temporary
relief of pain associated
with sore and aching
muscles in the shoulder,
waist, back, neck, upper
extremities and lower
extremities due to strain
from exercise or normal
household work | 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 | The Livia is designed
for symptomatic relief
and management of
chronic pain, and 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. The Livia is | Subject device has
the same
technological
features as the
primary predicate
(TENS + heating)
excluding PMS.
Subject device
combines the heat
output parameter
on primary
predicate device
and the
stimulation output | |
| | indicated for temporary
relief of pain associated
with dysmenorrhea
(menstrual cramps)
when used with over-
the-counter pain
medication. In addition,
it also provides a heat
function intended for
temporary relief of
minor aches and pains. | 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, and buttocks. Not
intended for use in any
therapy or for the
treatment of any
medical condition or
disease.
It is also intended to
temporarily increase
local blood circulation
in the healthy muscles
of lower extremities.
Heating Mode
Temporary relief of
minor aches and pains. | also indicated for
temporary relief of pain
associated with
dysmenorrhea
(menstrual cramps)
when used with over-
the-counter pain
medication. | parameter on
reference device,
which contain the
indication for use
on dysmenorrhea. | |
| FDA Product Code | NUH | NUH, NGX, NYN,
IRT | NUH | Identical to
reference device | |
| Prescription or OTC | OTC | OTC | OTC | Identical to
primary predicate
and reference | |
| | | | | | device |
| Power Source(s) | | Rechargeable battery | Rechargeable battery | Rechargeable battery | Identical to
primary predicate
device and
reference device |
| Function and Design | | Electrical stimulation
and heat | Electrical stimulation
and heat | Electrical stimulation | Identical to
primary predicate
device |
| Heating setting | | Nonadjustable | Low and high | N/A | No different in
safety or
effectiveness from
primary predicate
device |
| Maximum Temperature
Setting (°C) | | 43 | 43 | N/A | Identical to
primary predicate
device |
| Output Pattern of the
Heating | | Delivers electrical
stimulation and heat
simultaneously | Delivers electrical
stimulation and heat
simultaneously | N/A | Identical to
primary predicate
device |
| Maximum
Output
Voltage
(Vp-p) | @ 500 Ω | 72 ±10% | Mode 1: This mode
cycles the following
modes
Mode 2: 31.2 ±20%
Mode 3: 46.0 ±20%
Mode 4: 42.0 ±20%
Mode 5: 27.6 ±20%
Mode 6: 27.6 ±20%
Mode 7: 40.8 ±20%
Mode 8: 23.2 ±20% | 65.6 ±10% | No different in
safety or
effectiveness from
reference device |
| | @ 2 kΩ | 112 ±10% | Mode 1: This mode
cycles the following
modes
Mode 2: 68.0 ±20%
Mode 3: 90.4 ±20%
Mode 4: 68.8 ±20%
Mode 5: 60.0 ±20% | 115 ±10% | |
| | | | Mode 6: 60.0 ±20% | | |
| | | | Mode 7: 84.0 ±20% | | |
| | | | Mode 8: 50.4 ±20% | | |
| | | | Mode 1: This mode
cycles the following | 121 ±10% | |
| | | 120 ±10% | modes | | |
| | | | Mode 2: 118 ±20% | | |
| | | | Mode 3: 124 ±20% | | |
| | @ 10 kΩ | | Mode 4: 78.4 ±20% | | |
| | | | Mode 5: 115 ±20% | | |
| | | | Mode 6: 115 ±20% | | |
| | | | Mode 7: 124 ±20% | | |
| | | | Mode 8: 99.2 ±20% | | |
| | | | Mode 1: This mode
cycles the following | | |
| | | 144 ±10% | modes | 130.4 ±10% | |
| | | | Mode 2: 62.4 ±20% | | |
| | @ 500 Ω | | Mode 3: 92.0 ±20% | | |
| | | | Mode 4: 84.0 ±20% | | |
| | | | Mode 5: 55.2 ±20% | | |
| | | | Mode 6: 55.2 ±20% | | |
| | | | Mode 7: 81.6 ±20% | | |
| | | | Mode 8: 46.4 ±20% | | |
| Maximum
Output
Current
(mAp-p) | | | Mode 1: This mode
cycles the following | | |
| | | 56 ±10% | modes | 57.5 ±10% | |
| | @ 2 kΩ | | Mode 2: 34.0 ±20% | | |
| | | | Mode 3: 45.2 ±20% | | |
| | | | Mode 4: 34.4 ±20% | | |
| | | | Mode 5: 30.0 ±20% | | |
| | | | Mode 6: 30.0 ±20% | | |
| | | | Mode 7: 42.0 ±20% | | |
| | | | Mode 8: 25.2 ±20% | | |
| | | 12 ±10% | Mode 1: This mode
cycles the following | 12.1 ±10% | |
| | @ 10 kΩ | | modes | | |
| | | | Mode 2: 11.8 ±20% | | |
| | | | | | |
| | | Mode 3: 12.4 ±20%
Mode 4: 7.84 ±20%
Mode 5: 11.5 ±20%
Mode 6: 11.5 ±20%
Mode 7: 12.4 ±20%
Mode 8: 9.92 ±20% | | | |
| Pulse Width (μs) | 100 | 5.6806 | 100 | Identical to reference device | |59.5
| Frequency (Hz) | 100 | Mode 1: This mode cycles the following modes
Mode 2: 73.5
Mode 3: 13.7
Mode 4: 1.24
Mode 5: 104.1
Mode 6: 104.1
Mode 7: 20.8
Mode 8: 178.5 | 100 | Identical to reference device | |
| Maximum Phase Charge (μC @ 500Ω) | 7.2 | Mode 1: This mode cycles the following modes
Mode 2: 11.5
Mode 3: 16.9
Mode 4: 15.5
Mode 5: 10.2
Mode 6: 10.2
Mode 7: 15.0
Mode 8: 8.54 | 6.56 | No different in safety or effectiveness from reference device | |
| Maximum Current Density (mA/cm² @ 500Ω) | 0.364 | Mode 1: This mode cycles the following modes
Mode 2: 2.23
Mode 3: 3.29
Mode 4: 3.00
Mode 5: 1.97
Mode 6: 1.97 | 0.492 | | |
6
7
8
9
10
| Mode 7: 2.91 | |||
|---|---|---|---|
| Mode 8: 1.66 | |||
| Maximum Power | |||
| Density (W/cm² @ | |||
| 500Ω) | 0.00185 | Mode 1: This mode | |
| cycles the following | |||
| modes | 0.00228 | ||
| Mode 2: 0.94 | |||
| Mode 3: 0.38~1.65 | |||
| Mode 4: 0.03 | |||
| Mode 5: 1.04 | |||
| Mode 6: 1.04 | |||
| Mode 7: 0.46 | |||
| Mode 8: 1.26 |
12. Similarity and Difference
Based on the comparison information in our submission, both subject device and primary predicate device have the same indication for use on TENS mode and heat mode, which relieve the pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities, and lower extremities due to strain from exercise or normal household work activities, and temporarily relieve the minor aches and pain. Primary predicate device has more indication for use on PMS mode, but subject device does not have a PMS mode.
Besides, the subject device added an indication for use on temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication as all of the TENS stimulation output parameters were based on reference device.
There is no difference in safety or effectiveness of the heat output parameters between subject device and primary predicate device. There is no difference in safety or effectiveness of TENS output parameters between subject device and reference device.
13. Conclusion
After a series of non-clinical tests to ensure our design outputs met the specified design inputs and needs of the user, we believe that the subject device, HIVOX OTC Electrical Stimulator (FT610-B), is substantially equivalent to the predicate device in safety and effectiveness.