(163 days)
No
The summary describes a standard electrical stimulator with pre-set and user-defined programs, but there is no mention of AI or ML technology being used for signal generation, program selection, or any other function.
Yes
The device is described as an OTC Electrical Stimulator intended for temporary relief of pain (TENS) and stimulation of healthy muscles (EMS), which are therapeutic applications.
No
The device is an electrical stimulator used for temporary pain relief and muscle stimulation, not for diagnosing conditions.
No
The device description explicitly states it is an "electro stimulation device" and describes hardware components like "two independent stimulation channels and four adhesive electrodes." It also mentions electrical impulses being sent into tissue via electrodes, which is a hardware function.
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 (SEM44 and SEM44-1) is an electrostimulation device that applies electrical impulses to the body's surface through electrodes. It is used for pain relief (TENS) and muscle stimulation (EMS).
- Lack of Specimen Analysis: The device does not analyze any biological specimens taken from the body. It directly interacts with the body's tissues and nerves.
Therefore, the intended use and mechanism of action of this device clearly place it outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
HIVOX OTC Electrical Stimulator, SEM44 -
TENS: The 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 (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.
EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
HIVOX OTC Electrical Stimulator, SEM44-1 -
TENS: The 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 (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.
Product codes (comma separated list FDA assigned to the subject device)
NUH, NGX
Device Description
HIVOX OTC Electrical Stimulator - SEM44 and SEM44-1, falls into the electro stimulation device category.
SEM44 provides two basic functions, TENS/EMS; SEM44-1 provides one basic function, TENS:
-
Electrical stimulation of nerve tracts (TENS)
-
Electrical stimulation of muscle tissue (EMS)
The two models also feature two independent stimulation channels and four adhesive electrodes which FDA cleared k number is K132588. For TENS, SEM44 and SEM44-1 are designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities .; For EMS, SEM44 is designed to be used for stimulating healthy muscles in order to improve and facilitate muscle performance. For these purposes, the user can either choose from pre-set programs or specify their own to suit the user's individual needs.
The principle of electro stimulation units is based on the imitation of impulses in our bodies that are transferred to nerve and muscle fibers with electrodes via our skin. The electrodes can be applied to many parts of the body. In certain applications the user will merely notice a slight tingling or vibrating sensation. For SEM44, the electrical impulses that are sent into the tissue influence the transmission of stimulation into nerves, nerve centers and muscle groups in the application area; for SEM44-1, the electrical impulses that are sent into the tissue influence the transmission of stimulation into nerves and nerve centers in the application area.
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 (arm), lower extremities (leg), abdomen and bottom
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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, HIVOX OTC Electrical Stimulator (SEM44, SEM44-1).
- Shelf Life
- Biocompatibility
- Software Validation
- Electromagnetic compatibility and electrical safety
- Function test
All the test results demonstrate HIVOX OTC Electrical Stimulator (SEM44, SEM44-1) meets the requirements of its pre-defined acceptance criteria and intended uses, and is substantially equivalent to the predicate devices.
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 for 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size, also in blue. The logo is simple and professional, and it is easily recognizable.
November 29, 2017
Hivox Biotek Inc. Linda Lin Territory Sales 5F., No. 123, Xingde Rd. Sanchong Dist. New Taipei City, 24158 Tw
Re: K171803
Trade/Device Name: HIVOX OTC Electrical Stimulators Model SEM44 and Model SEM44-1 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: August 21, 2017 Received: August 31, 2017
Dear Linda Lin:
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. 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); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
William J. Heetderks -S 2017.11.29 20:14:45 -05'00'
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
HIVOX OTC Electrical Stimulator (SEM44, SEM44-1)
Indications for Use (Describe)
HIVOX OTC Electrical Stimulator, SEM44 -
TENS: The 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 (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.
EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
HIVOX OTC Electrical Stimulator, SEM44-1 -
TENS: The 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 (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.
| 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
Traditional 510(k), K171803/AIR Section 5 - 510(k) Summary
510(k) SUMMARY
| 5.1 | Type of Submission: | Traditional |
|---|---|---|
| 5.2 | Date of Summary: | November 29, 2017 |
| 5.3 | 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: | Mr. Linda Lin | |
| (linda.lin@hivox-biotek.com) |
5.4 Identification of the Device:
| Proprietary/Trade name: | HIVOX OTC Electrical Stimulator |
|---|---|
| Model Number: | SEM44, SEM44-1 |
| Classification Product Code: | NUH |
| Subsequent Product Code: | NGX |
| Regulation Number: | 1) 882.5890 |
- 890.5850 |
| Regulation Description: | 1) Transcutaneous electrical nerve
stimulator for pain relief - Powered muscle stimulator |
| Review Panel: | 1) Neurology - Physical Medicine |
| Device Class: | II |
5.5 Identification of the Predicate Device:
| Predicate Device Name: | OTC Electrical stimulator |
|---|---|
| Model Number: | MT9001, LT3060 |
| Manufacturer: | Shenzhen Dongdixin Technology Co., Ltd. |
4
| Classification Product Code: | NUH |
|---|---|
| Subsequent Product Code: | NGX |
| Regulation number: | 882.5890 |
| Device Class: | II |
| 510(k) Number: | K130802 |
| Predicate Device Name: | Tyece OTC TENS Device |
| Model Number: | SEM44 |
| Manufacturer: | SAVIA Ltd. |
| Classification Product Code: | NUH |
| Regulation number: | 882.5890 |
| Device Class: | II |
| 510(k) Number: | K150386 |
5.6 Intended Use/ Indications for Use of the Device
HIVOX OTC Electrical Stimulator, SEM44 -
TENS: The 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 (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.
EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
HIVOX OTC Electrical Stimulator, SEM44-1 -
TENS: The 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 (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.
5
5.7 Device Description
HIVOX OTC Electrical Stimulator - SEM44 and SEM44-1, falls into the electro stimulation device category.
SEM44 provides two basic functions, TENS/EMS; SEM44-1 provides one basic function, TENS:
-
Electrical stimulation of nerve tracts (TENS)
-
Electrical stimulation of muscle tissue (EMS)
The two models also feature two independent stimulation channels and four adhesive electrodes which FDA cleared k number is K132588. For TENS, SEM44 and SEM44-1 are designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities .; For EMS, SEM44 is designed to be used for stimulating healthy muscles in order to improve and facilitate muscle performance. For these purposes, the user can either choose from pre-set programs or specify their own to suit the user's individual needs.
The principle of electro stimulation units is based on the imitation of impulses in our bodies that are transferred to nerve and muscle fibers with electrodes via our skin. The electrodes can be applied to many parts of the body. In certain applications the user will merely notice a slight tingling or vibrating sensation. For SEM44, the electrical impulses that are sent into the tissue influence the transmission of stimulation into nerves, nerve centers and muscle groups in the application area; for SEM44-1, the electrical impulses that are sent into the tissue influence the transmission of stimulation into nerves and nerve centers in the application area.
6
5.8 Non-clinical Testing
A series of safety and performance tests were conducted on the subject device, HIVOX OTC Electrical Stimulator (SEM44, SEM44-1).
- Shelf Life
- . Biocompatibility
- Software Validation
- Electromagnetic compatibility and electrical safety
- Function test
All the test results demonstrate HIVOX OTC Electrical Stimulator (SEM44, SEM44-1) meets the requirements of its pre-defined acceptance criteria and intended uses, and is substantially equivalent to the predicate devices.
5.9 Clinical Testing
No clinical test data was used to support the decision of substantial equivalence.
5.10 Substantial Equivalence Determination
The HIVOX OTC Electrical Stimulator (SEM44, SEM44-1) submitted in this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared OTC Electrical stimulator Models MT9001, LT3060 (K130802) and Tyece OTC TENS Device, Model SEM44 (K150386). Differences between the devices cited in this section do not raise any new issue of substantial equivalence.
7
| Item | Subject device | Predicate device I | Substantial equivalence determination |
|---|---|---|---|
| Proprietary Name | HIVOX OTC Electrical Stimulator | OTC Electrical stimulator | N/A |
| Model | SEM44 | ||
| SEM44-1 | MT9001 | ||
| LT3060 | |||
| 510(k) No. | (to be assigned) | K130802 | |
| Intended Use | SEM44 – | ||
| TENS: The 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 (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities. | |||
| EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance. | MT9001 - | ||
| TENS: The 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 (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. | |||
| EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance. | |||
| LT3060 - | |||
| TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder waist back neck | Similar. | ||
| Both devices utilize TENS to release pain associated with sore and aching muscles, and EMS to improve and facilitate muscle performance. |
8
| shoulder, waist, back, neck, upper extremities (arm), upper extremities (arm), lower extremities (leg) abdomen and bottom due to strain from exercise or normal household work activities. | and lower extremities (leg) due to strain from exercise or activities. normal household work activities. | ||||
|---|---|---|---|---|---|
| Type of use | OTC | OTC | Same | ||
| Basic Unit Characteristics | |||||
| Power Source | 4.5V (batteries, 3x1.5V AAA) | 9V batteries | Different but does not adversely impact safety and effectiveness of subject device | ||
| Method of Line Current Isolation | N/A | N/A | Same | ||
| Patient Leakage Current | Normal condition | N/A | 0.61μA | This parameter is not applicable to subject device. | |
| Single fault condition | N/A | 0.68μA | |||
| Number of Output Modes | TENS: 15 | ||||
| EMS: 35 | TENS: 1 | ||||
| EMS: 1 | Different but does not adversely impact safety and effectiveness of subject device | ||||
| Number of Output Channels | Synchronous or Alternating | 2 Synchronous | Alternating | Different but does not adversely impact safety and effectiveness of | |
| Method of | |||||
| Channel | |||||
| Isolation | subject device | ||||
| By electrical circuit and | |||||
| software | By electrical circuit and | ||||
| software | Same | ||||
| Regulated Current or | |||||
| Regulated Voltage? | Regulated voltage | Current control | Different but | ||
| does not | |||||
| adversely impact | |||||
| safety and | |||||
| effectiveness of | |||||
| subject device | |||||
| Software/Firmware/ | |||||
| Microprocessor Control? | Yes | Yes | Same | ||
| Automatic Overload Trip? | Yes | Yes | Same | ||
| Automatic No-Load Trip? | Yes | Yes | Same | ||
| Automatic Shut Off? | Yes | Yes | Same | ||
| User Override Control? | Yes | Yes | Same | ||
| Indicator | |||||
| Display | On/Off | ||||
| Status | Yes | Yes | Same | ||
| Low Battery | Yes | Yes | Same | ||
| Voltage/ | |||||
| Current | |||||
| Level | Yes | Yes | Same | ||
| Timer Range (minutes) | 5-100 minutes | 1-60 minutes | Different but | ||
| does not | |||||
| adversely impact | |||||
| safety and | |||||
| effectiveness of | |||||
| subject device | |||||
| Compliance with Voluntary | |||||
| Standards | IEC 60601-1, | ||||
| IEC 60601-1-2. | IEC 60601-1, | ||||
| IEC 60601-1-2. | Same |
9
10
| | IEC 60601-2-10,
ISO10993-5/10 | IEC 60601-2-10,
ISO10993-5/10 | | | |
|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|----------------------------------|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Compliance with 21 CFR
898-7 | Yes | Yes | Same | | |
| Weight | 89 g (including belt clip,
without batteries),
123 g (including belt clip
and batteries) | 128g (including batteries) | Slightly different
but does not
impact safety and
effectiveness of
subject device | | |
| Dimensions [L x W x T] | 132 x 63 x 29.5 mm
(including belt clip) | 117 x 60 x 34 mm | Slightly different
but does not
impact safety and
effectiveness of
subject device | | |
| Housing Materials and
Construction | ABS | ABS | Same | | |
| Output Specifications | | | | | |
| Waveform (e.g., pulsed
monophasic, biphasic) | Biphasic | Biphasic | Same | | |
| Shape (e.g., rectangular,
spike, rectified sinusoidal) | Square | Square | Same | | |
| Maximum
Output Voltage
(Volts, Vpp) | @500Ω | 100±10% | 96±20%
(48±20% (Vp)) | Different but | |
| | @2KΩ | 180±10% | 200±20%
(100±20%
(Vp))
228±20%
(114±20%
(Vp)) | does not
adversely impact
safety and | |
| | @10KΩ | 250±10% | 210±20%
(105±20%
(Vp))
230±20%
(115±20%
(Vp)) | effectiveness of
subject device | |
| Maximum | @500Ω | 200±10% | 96±20% | Different but | |
| | | | | | |
| Output
Current (mA) | @2KΩ | 90±10% | 50±20% | 57±20% | does not
adversely impact
safety and
effectiveness of
subject device |
| | @10KΩ | 25±10% | 10.5±20% | 11.5±20% | |
| Duration of primary phase | | 50-450μS | | 50-300μS | Different but
does not
adversely impact
safety and
effectiveness of
subject device |
| Pulse Duration | | 50-450μS | | 50-300μS | Different but
does not
adversely impact
safety and
effectiveness of
subject device |
| Frequency | | 1-150Hz | 1-150Hz | | Same |
| For interferential modes
only – Beat Frequency | | N/A | N/A | | Same |
| For
multi-program
waveforms
only – | Symmetrical
Phases? | N/A | Yes | | This parameter is
not applicable to
subject device. |
| | Phase
Duration | N/A | 50-300μS | | |
| Net charge (micro coulombs
µC) (per pulse) | | 0.001μC@500Ω | 0μC@500Ω | | Same |
| method of achieving zero
net charge | | N/A | biphasic and leading
polarity alternates for each
successive, Pulse + and
pulse – pulse channel | | This parameter is
not applicable to
subject device. |
| Max. phase charge (mC) | | 0.045@500Ω | 0.0288@500Ω | | Different but
does not |
| | | | | | adversely impact
safety and
effectiveness of
subject device |
| | | | | | Different but
does not
adversely impact
safety and
effectiveness of
subject device |
| Max. current Density
(mA/cm², r.m.s) | | 0.667@500Ω | | 1.15@500Ω | Different but
does not
adversely impact
safety and
effectiveness of
subject device |
| Max. Average current
(average absolute value),
mA | | 13.5@500Ω | | 4.32@500Ω | Different but
does not
adversely impact
safety and
effectiveness of
subject device |
| Max. Average Power
Density, W/cm² (using
smallest electrode
conductive surface area) | | 0.0046@500Ω | | 0.373@500Ω | Different but
does not
adversely impact
safety and
effectiveness of
subject device |
| Burst
Mode
(i.e.
pulse
trains) | (a) Pulses per burst | 3 | 7 | N/A | Different but
does not
adversely impact
safety and
effectiveness of
subject device |
| | (b) Bursts per
second | 2/60Hz | 0.5/1/2/3/4/5
Hz | N/A | Different but
does not
adversely impact
safety and
effectiveness of
subject device |
| | (c) Burst duration | 36ms | 70ms | N/A | Different but
does not
adversely impact
safety and
effectiveness of
subject device |
| | (d) Duty cycle | 36ms/390ms | 35ms/350ms | N/A | Different but
does not
adversely impact
safety and
effectiveness of
subject device |
| ON Time (seconds) | | 2 | N/A | 1-30 | Similar and does
not impact safety
and effectiveness
of subject device |
| OFF Time (seconds) | 2 | N/A | 1-60 | Similar and does
not impact safety
and effectiveness
of subject device | |
| Electrode area | 20.25sqcm x4 (81sqcm) | 25sqcm x2 (100sqcm) | Different but
does not
adversely impact
safety and
effectiveness of
subject device | | |
| Average DC current through
electrodes when device is on
but no pulses are being
applied (µA) | 0 | 0 | Same | | |
11
12
13
| Item | Subject device | Predicate device II | Substantial
equivalence
determination |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Proprietary Name | HIVOX OTC Electrical
Stimulator | Tyece OTC TENS Device | N/A |
| Model | SEM44-1 | SEM44 | N/A |
| 510(k) No. | (to be assigned) | K150386 | N/A |
| Intended Use | TENS: The 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 (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or | The Tyece OTC TENS Device, Model SEM44 is to be used for temporary relief of pain associated with sore and aching muscles in the lower back, arms, or legs due to strain from exercise or normal household activities. | Similar.
Both devices utilize TENS to release pain associated with sore and aching muscles. |
14
| | | household
normal
work | | | | | |
|-----------------------------------------------|-------------------------------------|---------------------------------------|-----------------------------------|---------------------------------------------------------------------------------------------------|--|--|--|
| | | activities. | | | | | |
| Type of use | | OTC | OTC | Same | | | |
| | Basic Unit Characteristics | | | | | | |
| Power Source | | 4.5V (batteries, 3x1.5V | 4.5V (batteries, 3x1.5V | Same | | | |
| | | AAA) | AAA) | | | | |
| | Method of Line Current
Isolation | N/A | N/A | Same | | | |
| Patient | Normal condition | N/A | N/A | Same | | | |
| Leakage
Current | Single fault
condition | N/A | N/A | | | | |
| Number of Output Modes | | TENS: 15 | 15 Modes (01-15) | Different but
does not
adversely impact
safety and
effectiveness of
subject device | | | |
| | Synchronous
Or
Alternating | 2 Synchronous | 2 Synchronous | Same | | | |
| Number of
Output
Channels | Method of
Channel
Isolation | By electrical circuit and
software | PCB Insulation
Boost Isolation | Different but
does not
adversely impact
safety and
effectiveness of
subject device | | | |
| Regulated Current or
Regulated Voltage? | | Regulated voltage | Regulated voltage | Same | | | |
| Software/Firmware/
Microprocessor Control? | | Yes | Yes | Same | | | |
| Automatic Overload Trip? | | Yes | No | Different but | | | |
15
| | | | | does not
adversely impact
safety and
effectiveness of
subject device |
|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Automatic No-Load Trip? | | Yes | Yes | Same |
| Automatic Shut Off? | | Yes | Yes | Same |
| User Override Control? | | Yes | Yes | Same |
| | On/Off
Status | Yes | Yes | Same |
| | Low Battery | Yes | Yes | Same |
| Indicator
Display | Voltage/
Current
Level | Yes | Yes for voltage | Similar and does
not impact safety
and effectiveness
of subject device |
| Timer Range (minutes) | | 5-100 minutes | 5-100 minutes | Same |
| Compliance with Voluntary
Standards | | IEC 60601-1,
IEC 60601-1-2,
IEC 60601-2-10,
ISO10993-5/10 | IEC 60601-1,
IEC 60601-1-2,
IEC 60601-2-10,
ISO10993-5/10 | Same |
| Compliance with 21 CFR
898-7 | | Yes | Yes | Same |
| Weight | | 89 g (including belt clip,
without batteries),
123 g (including belt clip
and batteries) | 101 g (including belt chip) | Slightly different
but does not
impact safety and
effectiveness of
subject device |
| Dimensions [W x H x D] | | 132 x 63 x 29.5 mm
(including belt clip) | 132 x 63 x 29.5 mm
(including belt clip) | Same |
| Housing Materials and
Construction | | ABS | ABS | Same |
| Output Specifications | | | | |
| Waveform (e.g., pulsed
monophasic, biphasic) | | Biphasic | Biphasic | Same |
| Shape (e.g., rectangular,
spike, rectified sinusoidal) | | Square | Square | Same |
| Maximum
Output Voltage
(Volts, Vpp) | @500Ω | 100±10% | 70±15% | Different but
does not
adversely impact
safety and
effectiveness of
subject device |
| | @2KΩ | 180±10% | 110±15% | |
| | @10KΩ | 250±10% | 190±15% | |
| Maximum
Output Current
(mA) | @500Ω | 200±10% | 86±15% | Different but
does not
adversely impact
safety and
effectiveness of
subject device |
| | @2KΩ | 90±10% | 23.3±15% | |
| | @10KΩ | 25±10% | 3.75±15% | |
| Duration of primary phase | | 50-450μS | 0 | Different but
does not
adversely impact
safety and
effectiveness of
subject device |
| Pulse Duration | | 50-450μS | 50-360μS | Different but
does not
adversely impact
safety and
effectiveness of
subject device |
| Frequency | | 1-150Hz | 1-150Hz | Same |
| For
multi-program | Symmetrical
Phases? | N/A | N/A | Same |
| waveforms
only | Phase
Duration | | | |
| Net charge (micro coulombs
μC) (per pulse) | $0.001μC@500Ω$ | $0.001μC @500Ω$ | Same | |
| Max. phase charge (mC) | $0.045@500Ω$ | $0.0454@500Ω$ | Different but
does not
adversely impact
safety and
effectiveness of
subject device | |
| Max. current Density
(mA/cm², r.m.s) | $0.667@500Ω$ | $0.790@500Ω$ | Different but
does not
adversely impact
safety and
effectiveness of
subject device | |
| Max. Average current
(average absolute value),
mA | $13.5@500Ω$ | $16.0@500Ω$ | Different but
does not
adversely impact
safety and
effectiveness of
subject device | |
| Max. Average Power
Density, W/cm² (using
smallest electrode
conductive surface area) | $0.0046@500Ω$ | $0.00632@500Ω$ | Different but
does not
adversely impact
safety and
effectiveness of
subject device | |
| Burst
Mode
(i.e.
pulse | (a) Pulses per burst | 3 | 4 | Different but
does not
adversely impact
safety and |
| | (b) Bursts per
second | 2/60Hz | 4/83Hz | adversely impact
safety and |
| | (c) Burst duration | 36ms | 0.18ms | safety and |
| trains) | (d) Duty cycle | 36ms/390ms | 35ms/60ms | effectiveness of
subject device |
| | ON Time (seconds) | 2 | 2 | Same |
| | OFF Time (seconds) | 2 | 2 | Same |
| | Electrode area | 20.25sqcm x4 (81sqcm) | 20.25sqcm x4 (81sqcm) | Same |
| | Average DC current through
electrodes when device is on
but no pulses are being
applied (µA) | 0 | 0 | Same |
16
17
18
Traditional 510(k), K171803/AIR Section 5 - 510(k) Summary
5.11 Similarity and Difference
The HIVOX OTC Electrical Stimulator (SEM44, SEM44-1) has been compared with "OTC Electrical stimulator Models MT9001, LT3060" and "Tyece OTC TENS Device, Model SEM44" respectively. The subject device has similar intended use, technological characteristics and same principle of operation as these predicate devices. Although there are several specifications that are different between two devices, the comparison analysis has been completed to demonstrate that the differences between these parameters would not adversely impact the safety and effectiveness of the subject device. The subject device has undergone safety and performance tests, and the results complied with the test requests. Therefore, the difference between the subject device and the predicate devices did not raise any problem of substantial equivalence. The subject device is substantially equivalent to the predicate devices in intended use, safety and performance claims.
5.12 Conclusion
After analyzing non-clinical laboratory studies and safety testing data, it can be concluded that the HIVOX OTC Electrical Stimulator (SEM44, SEM44-1) is substantially equivalent to the predicate devices.