(245 days)
No
The device description and performance studies focus on standard electrical stimulation technology and regulatory compliance, with no mention of AI or ML capabilities.
Yes
The device is described as relieving temporary pain and conditioning muscles, which are therapeutic functions.
No
The intended use and device description clearly state that this device is used for the temporary relief of pain and muscle conditioning through electrical stimulation (TENS and EMS), not for diagnosing any medical condition.
No
The device description explicitly details hardware components such as a battery-operated wireless pulse generator, wireless receivers, electrodes, a wireless remote control unit, and a charging unit. It also mentions electrical safety and EMC testing, which are relevant to hardware.
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 (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Hi-Dow Wireless TENS/EMS System is a therapeutic device that applies electrical stimulation to the body's surface for pain relief and muscle conditioning. It does not analyze any biological samples.
- Intended Use: The intended use clearly describes the application of electrical impulses to the body for therapeutic purposes, not for diagnostic testing of samples.
- Device Description: The description details the components and function of an electrical stimulator, not a device for analyzing biological specimens.
Therefore, the Hi-Dow Wireless TENS/EMS System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NUH, NGX
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.
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
Not Found
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)
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 the patient or operator.
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 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
1
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
2
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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3
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: TENS |
- Powered Muscle Stimulator |
| Classification: | 1. Stimulator, Nerve, Transcutaneous, Over-The-Counter - Stimulator, Muscle, Powered, Over-the-Counter |
| Classification Regulation: | 1. 21 CFR 882.5890 - 21 CFR 890.5850 |
| Product Code: | 1. NUH - NGX |
| Classification Panel: | 1. Neurology - Physical Medicine |
| Device Classification: | Class 2 |
| Contraindications: | Do not use this device if you have a cardiac pacemaker, implanted
defibrillator, or other implanted metallic or electronic device. Such
use could cause electric shock, burns, electrical interference, or
death. |
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)
4
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
5
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
6
14. Substantial Equivalence Discussion
| Secondary Predicate | |||
|---|---|---|---|
| Elements of Comparison | Subject device | Predicate Device | Device |
| 510(k) Number | K163393 | K102598 | K130723 |
| Device Name and | |||
| Model | Powered Muscle Stimulator and | ||
| Transcutaneous electrical nerve stimulator | |||
| for pain relief HD-5N | JQ-5C | FDES106(ED406) Mini | |
| TENS&EMS Device | |||
| Manufacturer | Hi-Dow Electron Technology(Hefei) | ||
| Inc., Ltd. | Hefei Jianqiao Sci-tech Development | ||
| Co., Ltd. | Famidoc Technology Co., Ltd | ||
| Intended Use & Indications for Use | 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: | |||
| Intended to be used to stimulate healthy | |||
| muscles in order to improve and | |||
| facilitate muscle performance. | To be used for the 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. | |||
| It is intended to be used to stimulate healthy | |||
| muscles in order to improve and facilitate | |||
| muscle performance. | For program N, B and H of TENS | ||
| mode | |||
| To be used for temporary relief of pain | |||
| associated with sore and aching | |||
| muscles due to strain from exercise or | |||
| normal household work activities. | |||
| For program El and E2 of EMS mode | |||
| Used to stimulate healthy muscles in | |||
| order to improve and facilitate | |||
| muscle 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 AAA |
| batteries | |||
| -Method of Line | |||
| Current Isolation | Type BF Applied Part | Type BF Applied Part | Type BF Applied Part |
7
| Patient Leakage Current | | NC | DC: