(118 days)
No
The description focuses on standard TENS technology with pre-set modes and does not mention any adaptive or learning capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is indicated for temporary relief of pain associated with sore and aching muscles, functioning as a personal stimulator delivering electric stimulation to nerves and muscles. Its intended use for pain relief aligns with the definition of a therapeutic device.
No
The device is described as a personal stimulator that reduces pain by delivering electric stimulation, which aligns with therapeutic rather than diagnostic purposes. Its intended use is for temporary pain relief.
No
The device description explicitly states it is composed of a stimulator, silicon electrode, and gel pads, which are hardware components.
Based on the provided information, the HANAROCare ReJu is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "temporary relief of pain associated with sore and aching muscles...". This describes a therapeutic purpose, not a diagnostic one.
- Device Description: The description explains that it's a "personal stimulator that reduces the pain by delivering a specific rhythmic electric stimulation to the nerves and the muscles...". This is a description of a physical therapy or pain management device, not a device used to test samples from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The HANAROCare ReJu does not fit this definition. It is a therapeutic device that applies electrical stimulation to the body.
N/A
Intended Use / Indications for Use
HANAROCare ReJu is indicated 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.
Product codes
NUH
Device Description
HANAROCare ReJu is a personal stimulator that reduces the pain by delivering a specific rhythmic electric stimulation to the nerves and the muscles through electrode attached to the skin (Transcutaneous Electrical Nerve Stimulation). Electric current delivered to the nerves reduces the pain. The subject device offers four different stimulation modes (Mode 1, Mode 2, Mode 3, and Combination Mode). It is composed of as stimulator, silicon electrode, and gel pads.
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) and lower extremities (leg)
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)
- Shelf Life Test: The following shelf life has been performed to validate 2 year shelf life of the subject device.
- Visual Inspection
- Gel Pad Adhesive Strength Test
- Electrical Conductivity Test
- Biocompatibility Test: The following biocompatibility tests for gel pad have been performed to validate the biocompatibility of the patient contacting part.
- ISO 10993-5: Cytotoxicity Test (Aggar Diffusion Assay)
- ISO 10993-10: Primary skin irritation study in rabbits (4 hour semi-occlusive application)
- ISO 10993-10: Contact Hypersensitivity in Albino Guiana Pigs Maximization Test
- The electrical tests for the subject device were evaluated in accordance with the following method and standards. (See section 11 for list of standards)
- Performance Test: Performance test was conducted to evaluate the characteristic parameters of the stimulus output waveform, and verify that the measurement values meet the criteria.
- Usability Study: Thirty (30) different users of various age, gender, and educational background participated in the study was to evaluate their performance in using various functions of the HANAROCare ReJu. The test result demonstrated the ease to use the HANAROCare ReJu.
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/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are connected and appear to be flowing or merging together. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 27, 2016
M.i.tech Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant Lk Consulting Group USA, Inc. 800 Roosevelt Ste 417 Irvine, California 92620
Re: K160893
Trade/Device Name: Hanarocare Reju Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NUH Dated: June 10, 2016 Received: June 17, 2016
Dear Ms. Chung:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours, William J. Heetderks -A ----------------------------------------------------------------------------------------------------------------------------------------------------------------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) K160893
Device Name
HANAROCare ReJu
Indications for Use (Describe)
HANAROCare ReJu is indicated 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
(K160893)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
1. Date: 07/18/2016
2. Applicant / Submitter
M.I.TECH Co., Ltd. 174. Habuk 2- gil. Jinwi-myeon, Pyeongtaek-si, Gyeonggi-do 17706, Republic of Korea Tel. +82-31-662-5645
3. U.S. Designated Agent
Priscilla Chung LK Consulting Group USA, Inc. 800 Roosevelt Ste 417. Irvine, CA 92620 Fax: 714.409.3357 Tel: 714.202.5789 Email: juhee.c(@LKconsultingGroup.com
4. Trade/Proprietary Name:
HANAROCare ReJu
5. Common Name:
Transcutaneous Electrical Nerve Stimulator
6. Classification:
Stimulator, Nerve, Transcutaneous, Over-the-counter (21 CFR 882.5890, Product code NUH, Neurology)
7. Device Description:
HANAROCare ReJu is a personal stimulator that reduces the pain by delivering a specific rhythmic electric stimulation to the nerves and the muscles through electrode attached to the skin (Transcutaneous Electrical Nerve Stimulation). Electric current delivered to the nerves reduces the pain. The subject device offers four different stimulation modes (Mode 1, Mode 2, Mode 3, and Combination Mode). It is composed of as stimulator, silicon electrode, and gel pads.
4
8. Indication for use:
HANAROCare ReJu is indicated 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.
9. Predicate Device:
-
· Primary Predicate Device: Prospera OTC TENS Electronic Pulse Massager(model: PL029) by Prospera Corporation (K122744)
-
Reference Predicate Device:
- HIVOX Electric Stimulator OTC TENS, Rapid Relief by HIVOX BIOTEK INC (K140650)
-
EasyStim TN28 OTC by EasyMed Instruments Co., Ltd. (K140168)
-
Electronic Pulse Stimulator/PL-029K by Shenzhen Jingkehui Electronic Co., Ltd. (K141260)
5
10. Substantial Equivalence:
| | Subject Device | Primary Predicate
Device | Reference Predicate
Device | Reference Predicate
Device | Reference Predicate
Device | Treatment Timer | | 20 minutes fixed | 5min, 10min | 20 minutes fixed | 20min, 25min,
30min,40min
depending on preset
program | Not specified |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|-------|------------------------------------------------------------------------------------------------------------------------|---------------|----------------------|----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k # | | K122744 | K140650 | K140168 | K141260 | Output Waveform | | Monophasic | Monophasic | Symmetrical Biphasic | Monophasic
rectangular | Not specified |
| Manufacturer | M.I.Tech Co., Ltd. | Prospera Corporation | HIVOX BIOTEK INC | EasyMed Instruments
Co., Ltd. | Shenzhen Jingkehui
Electronic Co., Ltd. | Shape | | Rectangular | Rectangular | Rectangular | Biphasic rectangular | Not specified |
| Trade/Proprietary
Name | HANAROCareReJu | Prospera OTC TENS
Electronic Pulse
Massager(model: PL029) | HIVOX Electric
Stimulator OTC TENS,
Rapid Relief | EasyStim TN28_OTC | Electronic Pulse
Stimulator/PL-029K | Housing Materials and
Construction | | Retardant Polycarbonate | ABS | Silicone | ABS | Not specified |
| Product Code | NUH | NUH, NGX | NUH | NUH | NUH | Weight(grams) | | 11 | 181.4 | Not specified | 146.5 | Not specified |
| Type of Use | Over the Counter | Over the Counter | Over the Counter | Over the Counter | Over the Counter | Dimensions(mm)
[W x H x D] | | 36 x 35 x 13.7 | 59 x 200 x 21 | 113 x 70x 10 | 66×136×30.7 | Not specified |
| Intended Use | HANAROCareReJu is
indicated 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. | 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. | The HIVOX Electric
Stimulator OTC TENS,
Rapid Relief Pennypad
PP-904. is indicated for
temporary relief of pain
associated with sore and
aching muscles in the
upper and
lowerextremities (arm
and/or leg), and lower
back due to strain
fromexercise or normal
household and work
activities. | It is intended for the
relief of pain
associated with sore or
aching muscles of the
lower back, arms, or
legs due to strain from
exercise or normal
household and work
activities. | 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 | Maximum
Output
Voltage
(volts) | @500Ω | (±10%)
• Mode 1 : 64
• Mode 2 : 67
• Mode 3 : 59
• Combination : This
mode cycles the
above modes | 49.6 | 57.6 | 68 | (±20%)
• Mode 1: 46.0
• Mode 2: 59.6
• Mode 3: 49.2
• Mode 4: 64.8
• Mode 5: 37.2
• Mode 6: This mode
cycles the above
modes.
• Mode 7: 71.2
• Mode 8: 64.0 |
| Principle of Operation | to generate small pulses
of electrical current and
deliver the pulses to a
user's skin through
electrode adhesive pads | to generate small pulses
of electrical current and
deliver the pulses to a
user's skin through
electrode adhesive pads | to generate small pulses
of electrical current and
deliver the pulses to a
user's skin through
electrode adhesive pads | to generate small
pulses of electrical
current and deliver the
pulses to a user's skin
through electrode
adhesive pads | to generate small pulses
of electrical current and
deliver the pulses to a
user's skin through
electrode adhesive pads | | @2kΩ | (±10%)
• Mode 1 : 113
• Mode 2 : 119
• Mode 3 : 108
• Combination: This
mode cycles the
above modes. | 99.2 | 89.6 | 102 | (±20%)
• Mode 1: 86.4
• Mode 2: 111
• Mode 3: 80
• Mode 4: 90.4
• Mode 5: 64.8
• Mode 6: This mode
cycles the above
modes.
• Mode 7: 122
• Mode 8: 89.6 |
| Power Source | Lithium-polymer, 3.7V | 3V Battery | CR2032 Lithium 3V | 2 Alkaline AA 1.5V
(LR6) Batteries | 2pcs AAA batteries, 3V | | | | | | | |
| Number of Output
Modes | 4 | 8 | 3 | 8 | 8 | | | | | | | |
| Number of output
channels | 1 | 2(Synchronous/Alternatin
g) | 1 | 2 | 2 | | | | | | | |
| Pulse strength | 015 Stages | 010 Stages | 0~15 Stages | Not specified | Not specified | | | | | | | |
6
7
| | @10kΩ | (±10%)
• Mode 1: 0.154
• Mode 2: 0.377
• Mode 3: 0.437
• Combination: This
mode cycles the above
modes.
• Mode 1: 0.051
• Mode 2: 0.124
• Mode 3: 0.144
• Combination: This
mode cycles the above
modes. | 1.4 | 2.828 | 0.188 | (±20%)
• Mode 1: 5.75
• Mode 2: 7.45
• Mode 3: 6.15
• Mode 4: 8.10
• Mode 5: 4.65
• Mode 6: This mode
cycles the above
modes.
• Mode 7: 8.90
• Mode 8: 8.00 |
8
9
10
| Maximum
Average
Power
Density
(mW/cm2) | @500Ω | (±10%)
• Mode 1 : 0.15
• Mode 2 : 0.893
• Mode 3 : 1.2
• Combination: This
mode cycles the above
modes.
• Mode 1 : 0.049
• Mode 2 : 0.295
• Mode 3 : 0.396
• Combination: This
mode cycles the above
modes. | 230 | 163 | 7.52 | (±20%)
• Mode 1: 3.10
• Mode 2: 0.79
• Mode 3: 0.95
• Mode 4: 0.18
• Mode 5: 0.72
• Mode 6: This mode
cycles the above
modes.
• Mode 7: 2.91
• Mode 8: 0.12 |
| ---------------------------------------------------- | ------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----- | ----- | ------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
The operational principle of the above listed predicate devices is to generate small pulses of electrical current and deliver the pulses to a user's skin through electrode adhesive pads such that the underlying nerves are activated with sore and aching muscles is temporarily relieved. Similarly, the operational principle of the subject device is to generate small pulses of electrical current and deliver the pulses to an ordinary user's skin through electrode adhesive pads such that the underlying nerves are activated and the pain associated with sore and aching muscles is temporarily relieved.
The table above illustrates the subject devices comparison with the predicate that the technical characteristics, features, specifications and intended use of the subject device are substantially equivalent to those of the predicate devices. The stimulation parameters of subject device are all in the range of those of predicate devices. The design differences between the subject device and the predicate devices are insignificant and does neither affect the intended use, nor alter the operational principle of the subject device.
The major difference between the subject devices is that the subject device has the safety feature of reducing and cutting off the output when it detects more than 3kΩ. If the voltage detected is more than 3kΩ resistive load, the device will determine that the electrode is not properly attached to the maximum output voltage to less than 15 V at open load. It will also alarm the user with LED light and the buzzer sound. If the condition lasts more than 3 minutes, it will automatically cut off the output and turn the device off. This feature is for safety and does not affect the performance of the
11
device; therefore, based on the information provided in this submission, we conclude that the subject device is substantially equivalent to the predicate devices.
11. Performance Data:
- Shelf Life Test: The following shelf life has been performed to validate 2 year shelf life of the subject device.
- Visual Inspection
- Gel Pad Adhesive Strength Test
- Electrical Conductivity Test
- · Biocompatibility Test: The following biocompatibility tests for gel pad have been performed to validate the biocompatibility of the patient contacting part.
- ISO 10993-5: Cytotoxicity Test (Aggar Diffusion Assay)
- ISO 10993-10: Primary skin irritation study in rabbits (4 hour semi-occlusive application)
- ISO 10993-10: Contact Hypersensitivity in Albino Guiana Pigs Maximization Test
- The electrical tests for the subject device were evaluated in accordance with the following method and standards.
| No. | Items | Test Method / Standard |
|---|---|---|
| 1 | IEC 60601-1 General requirements for basic safety and | |
| essential performance | IEC 60601-1:2005(Third Edition) | |
| 2 | IEC 60601-2-10 Particular requirements for the basic | |
| safety and essential performance of nerve and muscle | ||
| stimulators | IEC 60601-2-10:2012(Second Edition) for use in | |
| conjunction with IEC 60601-1:2005(Third | ||
| Edition) | ||
| 3 | IEC 60601-1-11 Medical Electrical Equipment: | |
| General requirements for basic safety and essential | ||
| performance-Collateral Standard: Requirements for | ||
| medical electrical equipment and medical electrical | ||
| systems used in the home healthcare environment | IEC 60601-1-11(First Edition): 2010 | |
| 4 | IEC 60601-1-6 General requirements for safety- | |
| Collateral Standard: Usability | IEC 60601-1-6:2010(Third Edition) | |
| 5 | EMC Test | IEC 60601-1-2:2007 |
| 6 | IEC 62366 Medical devices-Application of usability | |
| engineering to medical devices | IEC 62366:2007(First Edition) for use in | |
| conjunction with IEC 60601-1-1-6:2010 |
12
| | IEC 62304Medical device software-Software life-cycle
processes | IEC 62304:2006(First Edition) |
|---|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| 7 | IEC 62304Medical device software-Software life-cycle
processes | IEC 62304:2006(First Edition) |
| 8 | Atmospheric Preconditioning(Ambient)
Atmospheric Conditioning(Hot, Humid)
Compression(Machine Apply and Release)
Vibration(Fixed Displacement)
Shock(Drop)
Vibration(Random) | ISTA 2014 Integrity Test Procedure 2A |
| 9 | RoHS verification | IEC 62321:2008: Procedures for the
Determination of Levels ofSix Regulated
Substances in Electrotechnical Products |
-
Performance Test:
Performance test was conducted to evaluate the characteristic parameters of the stimulus output waveform, and verify that the measurement values meet the criteria. -
Usability Study:
Thirty (30) different users of various age, gender, and educational background participated in the study was to evaluate their performance in using various functions of the HANAROCare ReJu. The test result demonstrated the ease to use the HANAROCare ReJu.
12. Conclusion:
The subject device and the predicate device are substantially equivalent in the areas of technical characteristics, general function, application, and intended use. The new device does not introduce a fundamentally new scientific technology. Therefore, it is our opinion that the HANAROCare ReJu described in this submission is substantially equivalent to the predicate device.