(179 days)
Not Found
No
The summary does not mention AI or ML, and the device description focuses on standard TENS functionality and wireless control via a mobile app with pre-defined modes. There is no indication of adaptive or learning algorithms.
Yes
Explanation: The device is intended for the relief of pain associated with sore or aching muscles, which is a therapeutic purpose. It is also described as a T.E.N.S. device, a type of therapeutic modality.
No
Explanation: The "Intended Use" section states the device is for "relief of pain associated with sore or aching muscles," which indicates a therapeutic purpose, not a diagnostic one. There is no mention of diagnosing conditions, identifying diseases, or evaluating physiological function.
No
The device description explicitly states it is a "portable battery powered T.E.N.S. device" with physical control buttons, indicating it is a hardware device with software control capabilities.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the relief of pain associated with sore or aching muscles. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is a T.E.N.S. (Transcutaneous Electrical Nerve Stimulation) device. T.E.N.S. devices deliver electrical impulses to the skin to alleviate pain. This is a physical therapy modality, not a method for diagnosing conditions by examining samples from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a disease or condition
- Using reagents or assays
In summary, the SmartTENS device is a therapeutic device for pain relief, not a diagnostic device that analyzes samples to provide information about a patient's health status.
N/A
Intended Use / Indications for Use
This device 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.
Product codes (comma separated list FDA assigned to the subject device)
NUH
Device Description
SmartTENS is a portable battery powered T.E.N.S. device with a wireless remote control feature for over-the-counter use, mainly operating in home, clinic, or hospital environments.
There are three control buttons on the unit itself: ON/OFF, intensity UP and intensity DOWM. The device is also designed to be controlled wirelessly through Bluetooth 4.0 connection (Frequency: 2402.0 - 2480.0 MHz) by a matched smart phone, which is featuring a mobile application (App) developed by EasyMed Instruments Co., Ltd.
A user entered 6-digit security code ensures the access to the device can only be the user's matched smart phone, thus avoiding unauthorized controls to the device.
There are totally seven (7) modes that are intended for pain relieving treatments to the following areas: Shoulder/ Arm, Lower Back and Leg/Foot. The specifications of each mode will be described in greater details in the User Manual.
Accessories:
M-CBX-C-008 Button-affixed Electrode
P-AE-002-A Replaceable Hydrogel Pads (gel-pads) 73mm x 62mm for external use. Pack of 2*
CBX-057-B Charger Cradle
M-PA-004-B Charging Adaptor
The accessories include an electrode and two hydrogel pads (gel-pads). The electrode is connected to the device by snapping the two buttons onto the device. One side of the adhesive gel-pads adheres to the electrode, and the other side adhere the device to the healthy intact skin of the user's body. Generally, the device produces either a fixed or modulated electrical signal through electrodes normally placed over the area of pain.
A built in Li-Ion battery is the power source of the device, which can be recharged for a limited large number of times. To charge the device, remove the electrode assembly by unsnapping it off the device, place the device on the charger cradle, insert the small pin of the charging adaptor into the charge cradle, and connect the charging adaptor to the electrical power supply.
Smart Phone Hardware Requirement:
-
- iPhone 4s or later models, or iPad 3 or later models, with iOS 6.0 or better system. Or,
-
- Smart phone or Tablet supporting BT 4.0 BLE feature with Android 4.3 or better system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower back, arms, or legs (for pain relief)
Indicated Patient Age Range
Adult
Intended User / Care Setting
Over-The-Counter Use; home, clinic, or hospital environments
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)
USABILITY STUDY: A usability study was conducted and showed that users were able to use the device correctly and safety.
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.
Not Found
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).
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines suggesting hair or movement. The profiles are arranged in a way that they appear to be connected. Encircling the image is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 29, 2015
Easymed Instruments Co., Ltd Mr. Jeffery Wu (Wu Tingjie) General Manager 5/F - 6/F, Block A, Gupo Gongmao Building, Fengxin Road, Fengxiang Industrial District, Daliang, 528300 Shunde, Foshan, Guangdong, CHINA
Re: K143430
Trade/Device Name: SmartTENS Regulation Number: 21 CFR 882.5890 Regulation Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter Regulatory Class: Class II Product Code: NUH Dated: April 30, 2015 Received: May 4, 2015
Dear Mr. Tingjie Wu:
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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" (21CFR 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.
Felipe Aquel -S
Carlos L. Peña, PhD, MS for 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) K143430
Device Name SmartTENS
Indications for Use (Describe)
This device 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.
Type of Use (Select one or both, as applicable)
| Registration under Part 21 CFR 601 Subpart E |
|---|
| Request for Exception under 21 CFR 601 Subpart G |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the Easymed logo. The logo is in blue and has a red line underneath it. Below the red line is the text "Easy for the relief of your suffering".
510(k) Summary
Date of submission prepared: October 6, 2014
| Submitter: | EasyMed Instruments Co., Ltd. |
|---|---|
| Address: | 5/F – 6/F, Block A, Gupo Gongmao Building, Fengxin Road, |
| Fengxiang Industrial District, Daliang, 528300 Shunde, Foshan, | |
| Guangdong, CHINA | |
| Tel: | +86 757 2809 1300 |
| Fax: | +86 757 2772 7868 |
| E-Mail: | jeffery@easymed.com.cn |
- Official Contact: Jeffery Wu (Wu Tingjie)
Address of the manufacturing facility: The same as above
SUBMITTED DEVICE:
| Generic Name: | Transcutaneous Electrical Nerve Stimulator (T.E.N.S.) |
|---|---|
| Proprietary or Trade Name: | SmartTENS |
| Common/Usual Name: | Stimulator, nerve, transcutaneous, over-the-counter |
| Classification Name: | Stimulator, nerve, transcutaneous, over-the-counter |
| 21 CFR 882.5890 | |
| Product Code: | NUH |
| Device Panel: | Neurology |
| Device Classification: | Class II |
PREDICATE DEVICES:
| Device Name: | EasyStim TN28_OTC |
|---|---|
| Manufacturer: | EasyMed Instruments Co., Ltd. |
| 510(k) Number: | K140168 |
| Product Code: | NUH |
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Image /page/4/Picture/0 description: The image shows the Easymed logo. The word "Easymed" is written in a large, bold, blue font. There is a red line underneath the word "Easymed". Below the red line, the words "Easy for the relief of your suffering" are written in a smaller, black font. There is a registered trademark symbol to the right of the word "Easymed".
WiTouch™ Pro Device Name: Manufacturer: Hollywog, LLC 510(k) Number: K120398 Product Code: GZJ. NYN
INDICATIONS FOR USE:
This device 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.
DEVICE DESCRIPTION:
SmartTENS is a portable battery powered T.E.N.S. device with a wireless remote control feature for over-the-counter use, mainly operating in home, clinic, or hospital environments.
There are three control buttons on the unit itself: ON/OFF, intensity UP and intensity DOWM. The device is also designed to be controlled wirelessly through Bluetooth 4.0 connection (Frequency: 2402.0 - 2480.0 MHz) by a matched smart phone, which is featuring a mobile application (App) developed by EasyMed Instruments Co., Ltd.
A user entered 6-digit security code ensures the access to the device can only be the user's matched smart phone, thus avoiding unauthorized controls to the device.
There are totally seven (7) modes that are intended for pain relieving treatments to the following areas: Shoulder/ Arm, Lower Back and Leg/Foot. The specifications of each mode will be described in greater details in the User Manual.
Accessories:
| M-CBX-C-008 | Button-affixed Electrode |
|---|---|
| P-AE-002-A | Replaceable Hydrogel Pads (gel-pads) 73mm x 62mm |
| for external use. Pack of 2* | |
| CBX-057-B | Charger Cradle |
| M-PA-004-B | Charging Adaptor |
The accessories include an electrode and two hydrogel pads (gel-pads). The electrode is connected to the device by snapping the two buttons onto the device. One side of the adhesive gel-pads adheres to the electrode, and the other side adhere the device to the healthy intact skin of the user's body. Generally, the device produces either a fixed or modulated electrical signal through electrodes normally placed over the area of pain.
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Image /page/5/Picture/0 description: The image shows the logo for Easymed. The logo is in blue and has a red line underneath it. Below the red line is the text "Easy for the relief of your suffering".
EasyMed Instruments Co., Ltd.
A built in Li-Ion battery is the power source of the device, which can be recharged for a limited large number of times. To charge the device, remove the electrode assembly by unsnapping it off the device, place the device on the charger cradle, insert the small pin of the charging adaptor into the charge cradle, and connect the charging adaptor to the electrical power supply.
Smart Phone Hardware Requirement:
-
- iPhone 4s or later models, or iPad 3 or later models, with iOS 6.0 or better system. Or,
-
- Smart phone or Tablet supporting BT 4.0 BLE feature with Android 4.3 or better system.
As above, the device is battery powered; there is no connection to AC mains supply.
ENVIRONMENT OF USE: Clinics, hospital and home environments
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Image /page/6/Picture/0 description: The image shows the brand name "Easymed" in a large, bold, blue font. Below the brand name, there is a thin red line. Underneath the line, the text "Easy for the relief of your suffering" is written in a smaller, blue font.
SUMMARY OF SUBSTANTIAL EQUIVALENCE
| Attribute | New Device | Predicate Device (1) | Predicate Device (2) |
|---|---|---|---|
| Product Name | SmartTENS | EasyStim TN28_OTC | WiTouch™ Pro |
| 510(K) number | K143430 | K140168 | K120398 |
| Product Code | NUH | NUH | GZJ, NYN |
| Regulation No. | 21 CFR 882.5890 | 21 CFR 882.5890 | CFR Title 21, 882.5890 |
| Indications for Use | This device 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. | This device 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. | This device is used for the symptomatic relief and management of chronic intractable back pain and relief of pain of the upper and lower back associated with arthritis. It is also used for adjunctive treament fro post-surgical and post-trauma acute back pain. |
| Patient Population | Adult | Adult | Not specified |
| Prescriptive or OTC | OTC | OTC | Prescription |
| Wireless Control | Yes | No | Yes |
| Number of output modes | 7 | 8 | 4 |
| Number of output channels | 1 | 2 | 1 |
| Waveform | Biphasic rectangular | ||
| Monophasic rectangular | Biphasic rectangular | ||
| Monophasic rectangular | Plused biphasic rectangular | ||
| Maximum Output Voltage(max) | |||
| 500 ohm | 68V @500Ω | 68V @500Ω | 35.2 V @500Ω |
| 2k ohm | 102V @ 2 kΩ | 102V @ 2 kΩ | 52V @ 2 kΩ |
| 10k ohm | 110V @10 kΩ | 110V @10 kΩ | 60.8V @10 kΩ |
| Maximum Output Current(max) | |||
| 500 ohm | 133mA | 133mA | 70mA @500Ω |
| 2k ohm | 51mA | 51mA | 26mA @ 2 kΩ |
| 10k ohm | 11mA | 11mA | 6mA @10 kΩ |
| Maximum Phase | 20.02µC | 20.02µC | 11.6µC |
| charge (500 ohm) | |||
| Maximum Average | |||
| Current (500 ohm) | 3.0375mA | 3.0375mA | 0.63mA |
| Maximum Current | |||
| Density (500 ohm) | 0.066mA/cm² | 0.188mA/cm² | 0.00149 mA/cm² |
| Maximum Average | |||
| Power Density | |||
| (500 ohm) | 2.66mW/ cm² | 7.52mW/ cm² | 0.0313mW/cm² |
| Frequency (Hz) | From 1Hz to 150Hz | From 1Hz to 150Hz | From 5Hz to 120Hz |
| Pulse Duration (us) | 50-250μs | 50-250μs | 120-250μs, |
| Burst Mode | Yes | Yes | No |
| Timer range(min) | 20min, 25min, 30min, 40min depending on preset program | 20min, 25min, 30min, 40min depending on preset program | 30min |
| Power Source | 3.7V rechargeable lithium battery | 2 Alkaline AA 1.5V (LR6) Batteries | 2 Alkaline AAA 1.5V DC Batteries |
| 1 CR2032 Lithium battery (Internal Power) | |||
| Dimensions (mm) | 155.4 x 64.6 x 19.1 | 66×136×30.7 | 18 x 191 x 90 |
| Weight | 64g | 146.5 grams | 4.8 oz |
| Housing material | TPE & ABS | ABS | Silicone & ABS |
| Microprocessor | |||
| control | Yes | Yes | Yes |
| Automatic | |||
| Overload trip | Yes | Yes | No |
| Automatic no-load | |||
| trip | Yes | Yes | No |
| Automatic shut-off | Yes | Yes | Yes |
| User override | |||
| control | Yes | Yes | Yes |
| Indicator Display: |
- On/Off Status?
- Low Battery?
- Voltage/Current Level?
-Output mode
-Time to cut-off | Yes
Yes
Yes
Yes
Yes | Yes
Yes
Yes
Yes
Yes | Yes
Yes
No
No
No |
| Electrode
compliance with 21
CFR 898 | Yes | Yes | Yes |
| Electrode cable | No | Yes | No |
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Image /page/7/Picture/0 description: The image shows the Easymed logo. The logo is in blue and has a registered trademark symbol next to it. Underneath the logo is a red line.
Easy for the relief of your suffering
EasyMed Instruments Co., Ltd.
Add: 5/F-6/F, Gupo Gongmao Building, Fengxin Road, Fengxiang Industrial District, Da Liang, 528300 ShunDe, GuangDong, China Fax: 86-757-27727868 Tel: 86-757-28091300
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Image /page/8/Picture/0 description: The image contains the logo for Easymed. The logo is in blue and has a registered trademark symbol next to it. Below the logo is a red line, and below that is the text "Easy for the relief of your suffering".
DIFFERENCES BETWEEN NEW DEVICE AND PREDICATE DEVICES
The technical characteristics of SmartTENS are similar to those of the predicate devices in design, intended use and function. Like the predicate device EasyStim TN28 OTC (K140168) and WiTouch™ Pro (K120398), the SmartTENS is a device used to apply an electrical current to electrodes on a patient's skin to relieve pain. The stimulation parameters of new device EasyStim TN28 OTC are same as those of predicate device EasyStim TN28 OTC (K140168) and similar to those of WiTouch™ Pro (K120398).
The predicate device EasyStim TN28_OTC (K140168) utilizes flexible wires between the electrodes and the electical stimulus generator. However, the new device SmartTENS utilize wireless remote controls for the considerations of a more user friendly design, which is similar to WiTouch™ Pro (K120398).
The intended design of SmartTENS limits the application for use to sites of lower back, arms and legs. The design includes Thermal Plastic Elastomer (TPE) electrodes that are intended for reuse and are button-affixed to the electrical stimulus generator. The unique connection makes the electrodes integral to the generator. The connection and shape of the electrodes limit application of the device. These unique characteristics of the integral electrodes are similar to those of WiTouch™ Pro (K120398) and insignificant as it relates to safety and effectiveness, which is not critical to the intended use between the referenced predicate devices.
The predicate device EasyStim TN28 OTC (K140168) utilizes affixed buttons as the sole method to control the electrical stimulus generator. The new device SmartTENS utilizes an additional method of a wireless remote control which similar to the predicate device WiTouch™ Pro (K120398). The difference is WiTouch™ Pro (K120398) utilizes radio frequency transveiver to control the electrical stimulus generator, while the SmartTENS ultilzes Bluetooth 4.0 as the wireless connecting technology to control the electrical stimulus generator. Furthermore, the remote controller is the Mobile Medical Application that need to be installed in the smart phone. This uniqueness of controlling the electrical stimulus generator by utilizing a Bluetooth wireless connecting technology is insignificant as it relates to safety and effectiveness, and is not critical to the intended use between the device and the referenced predicate devices.
Technological characteristics, features, specifications and intended uses of the new device SmartTENS are substantially equivalent to the referenced predicate devices. The differences that exist between SmartTENS and predicate devices are insignificant in the terms of safety or effectiveness.
9
PERFORMANCE TESTS
| FDA recognition No. | Standard Title |
|---|---|
| 19-5 | AAMI/ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 |
| And A2:2010/(R)2012 (Consolidated Text) Medical Electrical | |
| Equipment - Part 1: General Requirements For Basic Safety And | |
| Essential Performance (IEC 60601-1:2005, Mod). (General I (QS/RM)) | |
| 19-2 | AAMI / ANSI / IEC 60601-1-2:2007/(R)2012, Medical Electrical |
| Equipment - Part 1-2: General Requirements For Basic Safety And | |
| Essential Performance - Collateral Standard: Electromagnetic | |
| Compatibility - Requirements And Tests (Edition 3). (General II (ES/EMC)) | |
| 19-6 | IEC 60601-1-11 Edition 1.0 2010-04, 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 [Including: Technical Corrigendum 1 | |
| (2011)]. (General II (ES/EMC)) | |
| 17-11 | IEC 60601-2-10 Edition 2.0 2012-06, Medical Electrical Equipment -- |
| Part 2-10: Particular Requirements For The Basic Safety And Essential | |
| Performance Of Nerve And Muscle Stimulators. (Neurology) | |
| 5-40 | ISO 14971: Second Edition 2007-03-01 Medical devices- Application of |
| Risk Management To Medical Devices. (General I (QS/RM)) | |
| 5-85 | IEC 60601-1-6 Edition 3.0 2010-01, Medical Electrical Equipment-Part |
| 1-6: General Requirements For Basic Safety and Essential | |
| Performance- Collateral Standard: Usability(General I (QS/RM)) | |
| 13-8 | IEC 62304 First Edition 2006-05, Medical devices software- Software |
| life cycle processes (Software/ Informatics) |
USABILITY STUDY:
A usability study was conducted and showed that users were able to use the device correctly and safety.
Add: 5/F-6/F, Gupo Gongmao Building, Fengxin Road, Fengxiang Industrial District, Da Liang, 528300 ShunDe, GuangDong, China Tel:
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Image /page/10/Picture/0 description: The image shows the logo for Easymed. The logo is in blue and has a red line underneath it. Below the red line is the text "Easy for the relief of your suffering".
CONCLUSION:
The new device SmartTENS has the same indications for use and similar technological characteristics to the predicate device EasyStim TN28 OTC (K140168) and WiTouch™ Pro (K120398). The stimulation parameters of new device SmartTENS are all in the same range of those of predicate devices. Thus, the new device SmartTENS is substantially equivalent to the predicate devices and any differences between the devices do not pose any new questions of safety and effectiveness.