(245 days)
TENS:
To be used for the temporary relief of pain associated with sore or aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
EMS:
It is intended for muscle conditioning, used for stimulating abdomen muscles in order to improve or facilitate muscle performance.
The Hi-Dow Wireless TENS/EMS System is a battery operated wireless pulse generator that uses radiofrequency signals sent from a wireless remote control unit to wireless receivers attached to the electrodes(s), which are attached to the skin at the area to be treated. The wireless remote controls the intensity and mode functions of the receiver. When used in TENS Modes, the electrical impulses generated by the receivers stimulate the nerves that are causing pain resulting in gentle electrical sensations instead of pain. When used in EMS modes, the electrical impulses generated by the receivers produce muscle contractions, these contractions help to condition and improve the muscles.
The Hi-Dow Wireless TENS/EMS System is a double-channel and 4 modes muscle stimulation system that helps to relieve minor muscular aches and pains.
The output of both channels can be adjusted individually for intensity in 20 levels and the treatment time is 45 minutes.
The device is powered by rechargeable Lithium Batteries which are permanently built into the main unit and can be recharged with the charging unit supplied with the device.
The Device consists of an electronic stimulatory module which generates the required stimulation signals, 3 sets of electrode pads and a plug-in charging unit.
The electrodes are designed for single-patient/multiple application use. Because of the adhesive nature of the biocompatible conductive hydro gel, no securing materials are required to secure the device to the patient's skin. The electrodes snap onto the receiver.
The provided text is a 510(k) summary for the Hi-Dow Wireless TENS/EMS System, Model HD-5N. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than providing detailed acceptance criteria and studies in the traditional sense of a clinical trial for novel device approval.
Therefore, the acceptance criteria and study information will be presented as they relate to the substantial equivalence determination for this type of device.
Here's the breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission, the "acceptance criteria" are typically demonstrating compliance with recognized standards and similarity to predicate devices, and "reported device performance" refers to the results of testing done to show this compliance and similarity.
| Acceptance Criteria (Demonstrated Compliance/Similarity) | Reported Device Performance (Summary of Findings) |
|---|---|
| Biocompatibility Standards: | |
| - ISO10993-1:2009 (risk management) | Biocompatibility evaluation for electrodes and gel conducted per FDA G95-1 and ISO 10993-1. |
| - ISO10993-5:2009 (in vitro cytotoxicity) | - Tests performed included ISO 10993-5. |
| - ISO10993-10:2010 (irritation/skin sensitization) | - Tests performed included ISO 10993-10. |
| Electrical Safety Standards: | |
| - IEC60601-1:2005 + A1:2012, C1:2009, A2:2010 (General requirements for basic safety and essential performance) | Tests performed on Model HD-5N in accordance with IEC 60601-1. |
| - IEC60601-2-10:2012 (Particular requirements for nerve and muscle stimulators) | Tests performed on Model HD-5N in accordance with IEC 60601-2-10. |
| - IEC 60601-1-11:2010 (Home healthcare environment) | Tests performed on Model HD-5N in accordance with IEC 60601-1-11. |
| Electromagnetic Compatibility (EMC) Standards: | |
| - IEC60601-1-2:2007 (EMC - Requirements and tests) | Tests performed on Model HD-5N in accordance with IEC 60601-1-2. |
| - FCC Part 15 (Conducted Emissions) | Tests performed on Model HD-5N in accordance with FCC Part 15. |
| - FCC Part 15 (Radiated Emissions) | Tests performed on Model HD-5N in accordance with FCC Part 15. |
| Software Verification and Validation: | |
| - FDA Guidance for Software in Medical Devices (Moderate Level of Concern) | Software verification and validation testing conducted, and documents provided as recommended by FDA guidance. |
| Technological Characteristics Comparison to Predicates: (Hi-Dow Model JQ-5C (K102598) and FDES106(ED406) Mini TENS&EMS Device (K130723)) | The Hi-Dow Wireless TENS/EMS System, Model HD-5N, shares very similar technological specifications and is in the same regulatory category as the reference device (K120398). The subject device delivers essentially the same electrical energy transdermally using electrodes and gel, similar to its predicates. Differences are primarily in how the control unit interacts with the electrodes (wireless vs. wired, battery type). Conclusion: "Based on the electrical characteristics tested under IEC 60601, the Hi-Dow Wireless Device performs the same as the cleared devices, the Hi-Dow Model JQ-5C and FDES106(ED406) Mini TENS&EMS Device. This supports the conclusion that it is as safe and as effective as the cleared devices for the stated indications." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of this 510(k) summary. The "test set" here refers to the actual device undergoing engineering and performance testing against standards, not a clinical data set. The document does not specify the number of units tested.
- Data Provenance: The tests for biocompatibility, electrical safety, EMC, and software verification/validation are typically conducted in a laboratory setting. The country of origin of the data is not specified, but the manufacturing entity is "Hi-Dow Electron Technology(Hefei) Inc., Ltd." which suggests China. These are prospective tests conducted on the device itself. No patient data provenance is relevant for this type of submission focused on engineering performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This 510(k) submission is for an electrical stimulation device (TENS/EMS) and relies on objective measurements against engineering standards and comparison to predicate devices, not on expert consensus for "ground truth" derived from clinical data (e.g., image interpretation). Experts involved would be those certifying compliance with the listed standards (e.g., electrical engineers, biocompatibility specialists), but their number and specific qualifications are not detailed in this summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to clinical endpoint adjudication by multiple experts, which is not part of this device's substantial equivalence pathway. The "adjudication" here is the assessment of compliance with predefined engineering standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices often involving AI, which is not the case for this TENS/EMS device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an electrical stimulator, not an algorithm, and its use inherently involves human interaction (application of electrodes, control of intensity and mode). "Standalone" performance as typically understood for AI algorithms is not relevant here. The device's "standalone" performance refers to its ability to meet the specified electrical and safety parameters independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this submission are the recognized international and national standards (e.g., IEC 60601 series, ISO 10993 series, FCC Part 15) for electrical safety, EMC, biocompatibility, and software validation, as well as the technical specifications and performance characteristics of the legally marketed predicate devices. The device's performance is compared against these objective engineering and regulatory benchmarks, not clinical "ground truth" like pathology or outcomes data.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data.
9. How the ground truth for the training set was established
- Not applicable, as no training set was used.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing design underneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 4, 2017
Hi-Dow International, Inc. % Schevon Salmon Associate Attorney Benjamin L. England & Associates, LLC 810 Landmark Drive, Suite 126 Glen Burnie, Maryland 21061
Re: K163393
Trade/Device Name: Hi-Dow Wireless TENS/EMS (Model HD-5N) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: July 11, 2017 Received: July 13, 2017
Dear Schevon Salmon:
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 device
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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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,
Michael J. Hoffmann -S
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
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Indications for Use
510(k) Number (if known) K163393
Device Name
Hi-Dow Wireless TENS/EMS System (Model HD-5N)
Indications for Use (Describe) TENS:
To be used for the temporary relief of pain associated with sore or aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
EMS:
It is intended for muscle conditioning, used for stimulating abdomen muscles in order to improve or facilitate muscle performance.
| 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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Date of Summary Preparation: 8/4/2017
1. Submitter
Hi-Dow International, Inc. 2555 Metro Blvd Maryland Heights, MO 63043 Tel: 314 569 2888 Fax: 314 997 0888 E-mail: echen@hidow.com Contact: Mr. Eric Chen
2. Name of the Device
| Proprietary Name: | Hi-Dow Wireless TENS/EMS System, Model HD-5N |
|---|---|
| Common Name: | 1. Transcutaneous Electrical Nerve Stimulator for pain relief: TENS2. Powered Muscle Stimulator |
| Classification: | 1. Stimulator, Nerve, Transcutaneous, Over-The-Counter2. Stimulator, Muscle, Powered, Over-the-Counter |
| Classification Regulation: | 1. 21 CFR 882.58902. 21 CFR 890.5850 |
| Product Code: | 1. NUH2. NGX |
| Classification Panel: | 1. Neurology2. Physical Medicine |
| Device Classification: | Class 2 |
| Contraindications: | Do not use this device if you have a cardiac pacemaker, implanteddefibrillator, or other implanted metallic or electronic device. Suchuse could cause electric shock, burns, electrical interference, ordeath. |
3. The Predicate Device
K102598, Hi-Dow Model JQ-5C Powered Muscle Stimulator (21 CFR 890.5850)
Transcutaneous Electrical Nerve Stimulator for pain relief (21 CFR 882.5890) This predicate has not been subject to a design-related recall.
4. Secondary Predicate
K130723, FDES106(ED406) Mini TENS&EMS Device Powered Muscle Stimulator (21 CFR 890.5850) Transcutaneous Electrical Nerve stimulator for pain relief (21 CFR 82.5890)
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5. Reference Device
K120398, WiTouch™ Pro, (Transcutaneous electrical nerve stimulator for pain relief) 21CFR 882.5890. This device is included to provide an example of a cleared radiofrequency controlled device in the TENS/PMS regulatory classification; it is not included for its specific intended use or product code. The Subject Device has very similar technological specifications and is in the same regulatory category.
6. Device Description
The Hi-Dow Wireless TENS/EMS System is a battery operated wireless pulse generator that uses radiofrequency signals sent from a wireless remote control unit to wireless receivers attached to the electrodes(s), which are attached to the skin at the area to be treated. The wireless remote controls the intensity and mode functions of the receiver. When used in TENS Modes, the electrical impulses generated by the receivers stimulate the nerves that are causing pain resulting in gentle electrical sensations instead of pain. When used in EMS modes, the electrical impulses generated by the receivers produce muscle contractions, these contractions help to condition and improve the muscles.
The Hi-Dow Wireless TENS/EMS System is a double-channel and 4 modes muscle stimulation system that helps to relieve minor muscular aches and pains.
The output of both channels can be adjusted individually for intensity in 20 levels and the treatment time is 45 minutes.
The device is powered by rechargeable Lithium Batteries which are permanently built into the main unit and can be recharged with the charging unit supplied with the device.
The Device consists of an electronic stimulatory module which generates the required stimulation signals, 3 sets of electrode pads and a plug-in charging unit.
The electrodes are designed for single-patient/multiple application use. Because of the adhesive nature of the biocompatible conductive hydro gel, no securing materials are required to secure the device to the patient's skin. The electrodes snap onto the receiver.
7. Intended Use of Device
TENS
The Hi-Dow Wireless TENS/EMS System. Model HD-5N is intended to be used for temporary relief of pain associated with sore or 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
Intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
8. Summary of Substantial Equivalence
The Hi-Dow Wireless TENS/EMS System, Model HD-5N and HI-Dow, Model JQ-5C (K102598) devices are very similar. They deliver essentially the same electrical energy transdermally using electrodes and gel. They differ in how the control unit interacts with the
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7. 510(k) Summ
electrodes. In Model JQ-5C, the control and the power delivery functions are housed in the same unit. Electrodes, attached to the patient, are connected directly to the control/power unit. The wireless device (Model HD-5N) separates the control aspect from the electrical power delivery unit. The Hi-Dow Wireless TENS/EMS system separates the control aspects from the electrical power delvery unit. The control unit sends radiofrequency signals to the receiving power delivery unit which generates impulses according to the corresponding mode of operation and level of treatment.
The technological characteristics of the Hi-Dow Wireless TENS/EMS System and secondary predicate, FDES106(ED406) Mini TENS&EMS Device, are very similar. They both deliver electrical energy transdermally using electrodes. They differ in how the control unit interacts with the electrodes and the performance data. In FDES106(ED406), the control and power delivery are housed in the same unit and electrodes are connected directed to the control/power unit. The devices also use AA batteries.
Table: The table below provides analysis of the similarities and difference between HD-5N, the predicate ((K102598 JQ-5C) and the secondary predicate device (K130723).
9. Comparison of Technological Characteristics with the Predicate Devices
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14. Substantial Equivalence Discussion
| Secondary Predicate | |||
|---|---|---|---|
| Elements of Comparison | Subject device | Predicate Device | Device |
| 510(k) Number | K163393 | K102598 | K130723 |
| Device Name andModel | Powered Muscle Stimulator andTranscutaneous electrical nerve stimulatorfor pain relief HD-5N | JQ-5C | FDES106(ED406) MiniTENS&EMS Device |
| Manufacturer | Hi-Dow Electron Technology(Hefei)Inc., Ltd. | Hefei Jianqiao Sci-tech DevelopmentCo., Ltd. | Famidoc Technology Co., Ltd |
| Intended Use & Indications for Use | TENSTo be used for the temporary relief ofpain associated with sore or achingmuscles in the shoulder, waist, back,upper extremities (arm), and lowerextremities (leg) due to strain fromexercise or normal household workactivities.EMS:Intended to be used to stimulate healthymuscles in order to improve andfacilitate muscle performance. | To be used for the temporary relief of painassociated with sore and aching muscles in theshoulder, waist, back, neck, upper extremities(arm), and lower extremities (leg) due to strainfrom exercise or normal household workactivities.It is intended to be used to stimulate healthymuscles in order to improve and facilitatemuscle performance. | For program N, B and H of TENSmodeTo be used for temporary relief of painassociated with sore and achingmuscles due to strain from exercise ornormal household work activities.For program El and E2 of EMS modeUsed to stimulate healthy muscles inorder to improve and facilitatemuscle performance. |
| Basic Unit Characteristics | |||
| Device Power Source(s) | DC 3.7V Lithium Battery | DC 3.7 V Lithium Battery | Battery powered, d.c. 3.0V, 2 X AAAbatteries |
| -Method of LineCurrent Isolation | Type BF Applied Part | Type BF Applied Part | Type BF Applied Part |
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| Patient Leakage Current | NC | DC:<10μA AC:<100 μA | DC:<10μA AC: < 100 μA | 0.9μΑ | |
|---|---|---|---|---|---|
| SFC | DC:<50μA AC:<500 μA | DC:<50μA AC: < 500 μA | 0.8μA | ||
| Number of Output Channels | 2 | 2 | 1 | ||
| Number of Output Modes | 4 | 6 | 5 | ||
| Synchronous or Alternating? | 2 Channel Asynchronous | 2 Channel Synchronous | Alternating | ||
| Method of Channel Isolation | Two separate devices, and useindependent power supply system. | Parallel | By Electrical Circuit and Software | ||
| Regulated Current or RegulatedVoltage? | Regulated Voltage | Regulated Voltage | Regulated Voltage | ||
| Software/Firmware/MicroprocessorControl? | Yes | Yes | Yes | ||
| Automatic Overload Trip? | No | No | Yes | ||
| Automatic No-Load Trip? | No | No | Yes | ||
| Automatic Shut Off | Yes | Yes | Yes | ||
| User Override Control ? | Yes | Yes | Yes | ||
| On/Off Status? | Yes | Yes | Yes | ||
| Indicator | Low Battery? | Yes | Yes | Yes | |
| Display | Voltage/CurrentLevel? | No | No | No | |
| Timer Range | 45mins | 10 ~ 60mins | 30 mins | ||
| Compliance with 21 CFR 898? | Yes | Yes | Yes | ||
| Weight (lbs., oz.) | Remote: 2.2 oz. | 1.5 oz. | .093 oz. | ||
| Receiver: 0.85oz. | |||||
| Dimensions (in.) [W x H x D] | Remote: 4.25"(W) x 2.1" (H) x 0.6" (D) | 3.15"(W) x 1.65" (H) x 0.55"(D) | 2.5"x1.77"x0.36" | ||
| Receiver:Φ2.25" (Diameter) x 0.47"(D) |
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| Electrode shape(square, round,rectangular, oval) andsize(L*W(cm)or area cm²) | Oval electrode pad(gel),4.53cm, 12cm²;Rectangular electrode pad(gel),94cm, 36cm²;Rectangular electrode pad(gel),9*6cm, 54cm²; | Oval electrode pad(gel), 9cm²; | N/A | |
|---|---|---|---|---|
| Housing Material and Construction | ABS | ABS and metal | Plastic (ABS)Enclosure | |
| Output Specifications | ||||
| Waveform (e.g., pulsed monophasic,biphasic) | Pulsed Biphasic | Pulsed Biphasic | Pulsed Biphasic | |
| Shape (e.g., rectangular, spike,rectified sinusoidal) | Rectangular | Rectangular | Square | |
| Formultiphasic | Symmetricalphases? | YES | YES | Yes |
| waveformsonly: | Step-i and Step-3Phase Duration(include units),(state range, ifapplicable),(both phases, ifasymmetrical) | TENS & EMS : 100µS | 100µS | - |
| Step-2 PhaseDuration (includeunits), (state range,if applicable), (bothphases, ifasymmetrical) | TENS & EMS : 100µS | 100µS | - | |
| Frequency (Hz) | (TENS) MODE 3: 1.28(TENS) MODE 4: 1~59.8(EMS) MODE 1: 52.3(EMS) MODE 2: 5.8 | 1~68 | TENS: 2 ~ 80EMS: 2 ~ 50 | |
| phase Duration(include units) (S) | (TENS) MODE 3: Continuous(TENS) MODE 4: 92.5(EMS) MODE 1: 4.6(EMS) MODE 2: 4.8 | Continuous / 4.5~93 | TENS: 200 ~ 350µSEMS: 250µS | |
| Maximum outputVoltage ,(Vpeak, specify units v) | (TENS) MODE 3: 48.5V@500Ω(TENS) MODE 4: 41.1V@500Ω(EMS) MODE 1: 37.9V@500Ω(EMS) MODE 2: 46.8V @500Ω | 62.4V@500Ω | TENS: 30.4V@500ΩEMS: 28V@500Ω | |
| Maximum output Current, (Ipeak,specify units mA) | (TENS) MODE 3: 97mA@500Ω(TENS) MODE 4: 82.2mA@500Ω(EMS) MODE 1: 75.8mA@500Ω(EMS) MODE 2: 93.6mA@500Ω | 124.8mA@500Ω | TENS: 60.8mA@500ΩEMS: 56mA@500Ω | |
| Net Charge, (µC per pulse) | (TENS) MODE 3: 9.7µC@500Ω(TENS) MODE 4: 8.22µC@500Ω(EMS) MODE 1: 7.5µC@500Ω(EMS) MODE 2: 9.36µC@500Ω | 0µC@500Ω | TENS: 15.2µC@500ΩEMS: 14µC@500Ω | |
| Maximum phase Charge, (µC) | (TENS) MODE 3: 38.8µC@500Ω(TENS) MODE 4: 32.88µC@500Ω(EMS) MODE 1: 15µC@500Ω(EMS) MODE 2: 37.44µC@500Ω | 49.92µC@500Ω | TENS:15.2µC@500ΩEMS: 14µC@500Ω | |
| MaximumCurrentDensity,(mA/cm²) | (TENS) MODE 3: 8.08mA/cm²@500Ω(TENS) MODE 4: 6.85mA/cm²@500Ω(EMS) MODE 1: 6.31mA/cm²@500Ω(EMS) MODE 2: 7.8mA/cm²@500Ω | 13.86mA@500Ω | TENS: 4.1mA/cm²@500ΩEMS: 3.77mA/cm²@500Ω | |
| Maximum Average Current( mA). | (TENS) MODE 3: 0.0124mA@500Ω(TENS) MODE 4: 0.492mA@500Ω(EMS) MODE 1: 0.393mA@500Ω(EMS) MODE 2: 0.054mA@500Ω | 0.761mA@500Ω | TENS: 0.51mA@500ΩEMS: 0.41mA@500Ω | |
| (mW/CM²), | Maximum Average Power Density(usingsmallestelectrode conductive surface area) | (TENS) MODE 3: 0.05W/cm²@ 500Ω(TENS) MODE 4: 1.68W/cm²@ 500Ω(EMS) MODE 1: 1.25W/cm²@ 500Ω(EMS) MODE 2: 0.21W/cm²@ 500Ω | 5.27 mW/cm2@ 500Ω | TENS: 2mW/cm²@500ΩEMS: 1.2mW/CM²@500Ω |
| Burst | Pulses per burst | Continuous / complex; 41~181 | Continuous / 38.5~510 | TENS: 7 |
| Bursts per second | Complex / 0.208~0.217 | 0.086~0.78 | TENS: 2 | |
| Mode(i.e.,pulse trains) | Burstduration(seconds) | Continuous / 4.6~92.5 | Continuous / 4.5~93 | TENS: .02 |
| ON Time(seconds) | 0.1 | 0.1 | - | |
| OFF Time(seconds) | 0.1 | 0.1 | - | |
| Remote communication mode? | RF: 2.4GHz transceiver | N/A | N/A | |
| Wireless | FCC Part 15 Conducted Emissions | N/A | N/A | |
| FCC Part 15 Radiated Emissions | ||||
| Remote Control:FCC ID:2ACD4HD-5N-TXDevice: FCC ID:2ACD4HD-5N-RX | ||||
| Additional Features | ||||
| Environment for operating | Temperature : 5°C to 40°C(41°F~104°F)Humidity(non-condensing) : 30%-75%,Atmospheric pressure : 700 to 1060Hpa | Temperature: 10°C | Temperature : 5°C to 40°C(41°F~104°F)Humidity(non-condensing) : 30%-85%, | |
| Environment for storage | Temperature: -10°Cto55°C (14°F~131°F)Humidity(non-condensing) : 10%-90%Atmospheric pressure : 700 to 1060Hpa | Temperature: -20°C | Temperature: -10°Cto50°C (14°F~122°F)Humidity(non-condensing) : 10%-90% (non-condensing) | |
| Standards | ||||
| Biocompatibility | All user directly contacting materials arecompliance with | EN ISO 10993-1:2009 | Compliant with requirements of ISO 10993-5and ISO 10993-10 standards | |
| ISO10993-1:2009/C1: 2010,ISO10993-5:2009,ISO10993-10:2010. | ||||
| Electrical Safety | IEC 60601-1:2005 (Third Edition) + Corr.1:2006 + Corr. 2:2007 + A1:2012 (or IEC60601-1:2012 reprint); IEC 60601-2-10:2012; also complies withANSI/AAMI ES60601-1:2005 + A1:2012,C1: 2009 and A2: 2010 EN 60601-1: 2006EN 60601-2-10: 2000 + A1: 2001 | EN 60601-1: 2006EN 60601-2-10: 2000 + A1: 2001 | Compliant with requirementsIEC 60601-1,IEC 60601-2-10, IEC 60601-1-1-2 | |
| EMC | IEC 60601-1-2:2007, IEC 60601-1-11:2010 Clause 12, IEC 60601-2-10:2012 Clause 201.17&202; | EN60601-1, EN60601-1-2, EN ISO14971:2009, EN 60601-2-10:2000 +A1:2001 | Compliant with requirements IEC 60601-1-2,IEC 60601-2-10. |
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10. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the electrodes and the gel used with these devices was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the flowing tests:
ISO10993-1: 2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process
ISO10993-5:2009, Biological Evaluation of Medical Devices- Part 5: Tests for In Vitro Cytotoxicity
ISO10993-10:2010, Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization
Electrical safety and electromagnetic compatibility (EMC) and Other Standards
The following tests were performed on the Hi-Dow Wireless TENS/EMS System, Model HD-5N device in accordance with the requirements of the design control regulations and established quality assurance procedures.
IEC60601-1:2005, Medical electrical equipment-Part 1: General requirements for basic safety, and essential performance. Also complies with ANSI/AAMI ES60601-1:2005 + A1:2012, C1: 2009 and A2: 2010, Medical electrical equipment-Part 1: General requirements for basic safety, and essential performance.
IEC60601-1-2:2007,EN60601-1-2:2007,Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility-Requirements and tests.
IEC60601-2-10:2012/EN60601-2-10:2015 Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of nerve and muscle stimulator IEC 60601-1-11: 2010/EN 60601-1-11: 2010; Medical electrical equipment - Part 1-11: 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
FCC Part 15 "Conducted Emissions"
FCC Part 15 "Radiated Emissions"
Software Verification and validation Testing
Software verification and validation testing were conducted and documents were provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software could result in injury to
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the patient or operator.
11. Conclusion
Based on the electrical characteristics tested under IEC 60601, the Hi-Dow Wireless Device performs the same as the cleared devices, the Hi-Dow Model JQ-5C and FDES106(ED406) Mini TENS&EMS Device. This supports the conclusion that it is as safe and as effective as the cleared devices for the stated indications.
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§ 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).