Who is the manufacturer of HANAROCare ReJu?

M.I.Tech Co., Ltd. filed the 510(k) submission for HANAROCare ReJu (K160893).

What is the FDA product code for HANAROCare ReJu?

NUH. It is classified under 21 CFR 882.5890 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for HANAROCare ReJu?

510(k) clearance (submission type: Traditional).

What are the predicate devices for HANAROCare ReJu?

Prospera OTC TENS Electronic Pulse Massager(model: PL029) (K122744); HIVOX Electric Stimulator OTC TENS, Rapid Relief (K140650); EasyStim TN28 OTC (K140168); Electronic Pulse Stimulator/PL-029K (K141260).

Who can help prepare an FDA 510(k) submission like HANAROCare ReJu?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

HANAROCare ReJu

K160893 · M.I.Tech Co., Ltd. · NUH · Jul 27, 2016 · Neurology

Device Facts

Record ID	K160893
Device Name	HANAROCare ReJu
Applicant	M.I.Tech Co., Ltd.
Product Code	NUH · Neurology
Decision Date	Jul 27, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.5890
Device Class	Class 2
Attributes	Therapeutic

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.

Device Story

HANAROCare ReJu is a personal transcutaneous electrical nerve stimulator (TENS) for OTC pain relief. Device generates rhythmic electrical pulses delivered to skin via adhesive gel pads; stimulates nerves to reduce pain. User selects from four stimulation modes (Mode 1, 2, 3, and Combination). Device is compact (36x35x13.7mm), battery-powered (3.7V Li-polymer), and operated by the user. Safety feature monitors impedance; if resistance exceeds 3kΩ (indicating poor electrode contact), device alerts user via LED/buzzer and automatically cuts output after 3 minutes. Healthcare providers do not operate the device; it is for patient self-use to manage muscle soreness. Benefits include non-pharmacological, temporary pain relief.

Clinical Evidence

Bench testing only. Includes shelf-life validation (visual, adhesive, conductivity), biocompatibility (ISO 10993-5 cytotoxicity, ISO 10993-10 irritation/hypersensitivity), and electrical safety/EMC testing (IEC 60601 series). A usability study with 30 participants of varying demographics confirmed ease of use.

Technological Characteristics

Retardant polycarbonate housing; 3.7V Lithium-polymer battery. Delivers monophasic electrical pulses via silicon electrodes and gel pads. Dimensions: 36x35x13.7mm. Weight: 11g. Features impedance-based safety cutoff (>3kΩ). Complies with IEC 60601-1, 60601-2-10, 60601-1-11, 60601-1-6, 60601-1-2, IEC 62366, and IEC 62304.

Indications for Use

Indicated for temporary relief of pain in shoulder, waist, back, neck, arms, and legs due to exercise or household work strain. For adult OTC use.

Regulatory Classification

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.

Predicate Devices

Prospera OTC TENS Electronic Pulse Massager(model: PL029) (K122744)
HIVOX Electric Stimulator OTC TENS, Rapid Relief (K140650)
EasyStim TN28 OTC (K140168)
Electronic Pulse Stimulator/PL-029K (K141260)

Submission Summary (Full Text)

{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) #### 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 (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 | 0~15 Stages | 0~10 Stages | 0~15 Stages | Not specified | Not specified | | | | | | | | {6}------------------------------------------------ {7}------------------------------------------------ | | @10kΩ | (±10%) <15 | 114 | 96.0 | 110 | (±20%) • Mode 1: 116 • Mode 2: 146 • Mode 3: 138 • Mode 4: 106 • Mode 5: 111 • Mode 6: This mode cycles the above modes. • Mode 7: 136 • Mode 8: 96.8 | |------------------------------------------------------|-------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|----------------------|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Maximum Output Current (mA) | @500Ω | (±10%) • Mode 1 : 128 • Mode 2 : 134 • Mode 3 : 118 • Combination: This mode cycles the above modes. | 18 | 115.2 | 113 | (±20%) • Mode 1: 92.0 • Mode 2: 119.2 • Mode 3: 98.4 • Mode 4: 129.6 • Mode 5: 74.4 • Mode 6: This mode cycles the above modes. • Mode 7: 142.4 • Mode 8: 128.0 | | | @2kΩ | (±10%) • Mode 1 : 57 • Mode 2 : 60 • Mode 3 : 54 • Combination: This mode cycles the above modes. | 3.2 | 44.8 | 51 | (±20%) • Mode 1: 43.2 • Mode 2: 55.5 • Mode 3: 40 • Mode 4: 45.2 • Mode 5: 32.4 • Mode 6: This mode cycles the above modes. • Mode 7: 61 • Mode 8: 44.8 | | | @10kΩ | (±10%) <15 | 0.6 | 9.6 | 11 | (±20%) • Mode 1: 11.6 • Mode 2: 14.6 • Mode 3: 13.8 • Mode 4: 10.6 • Mode 5: 11.1 • Mode 6: This mode cycles the above modes. • Mode 7: 13.6 • Mode 8: 9.7 | | Max Pulse Freq.(Hz) | | (±10%) • Mode 1 : 2Hz • Mode 2: 16.7Hz • Mode 3 : 33.3Hz • Combination: This mode cycles the above modes. | 0.5~86 | 2, 5, and 40 (Fixed) | 1~150 | (±20%) • Mode 1: 54.3 • Mode 2: 35.7 • Mode 3: 62.5 • Mode 4: 6.7 • Mode 5: 83.3 • Mode 6: This mode cycles the above modes. • Mode 7: 19.8 • Mode 8: 1.2 | | Pulse period, msec | | (±10%) • Mode 1 : 500 • Mode 2 : 60 • Mode 3 : 30 • Combination: This mode cycles the above modes. | Not specified | Not specified | Not specified | 12~832 | | Pulse Width(μsec) | | (±10%) • Mode 1 : 115 • Mode 2 : 75 • Mode 3 : 65 • Combination: This mode cycles the above modes. | 100~200 | 200(fixed) | 50-250, in steps of 50 | 50~100 | | Maximum Phase Charge(µC) | @500Ω | ((±10%) • Mode 1: 14.72 • Mode 2: 10.05 • Mode 3: 7.67 • Combination: This mode cycles the above modes. | 23 | 23.04 | 20.02 | (±20%) • Mode 1: 19.9 • Mode 2: 6.0 • Mode 3: 4.9 • Mode 4: 6.5 • Mode 5: 3.7 • Mode 6: This mode cycles the above modes. • Mode 7: 33.0 • Mode 8: 25.6 | | Maximum Current Density (mA/cm2, r.m.s.) | @500Ω | (±10%) <Standard Electrode: 12.57cm2> • Mode 1: 0.154 • Mode 2: 0.377 • Mode 3: 0.437 • Combination: This mode cycles the above modes. <Monarch Electrode: 38.09 cm2> • 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%) <Standard Electrode: 12.57cm2> • Mode 1 : 0.15 • Mode 2 : 0.893 • Mode 3 : 1.2 • Combination: This mode cycles the above modes. <Monarch Electrode: 38.09 cm2> • 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.

HANAROCare ReJu

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

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Submission Summary (Full Text)

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Indications for Use

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