(90 days)
No
The device description and performance studies focus on standard electrical stimulation technology and safety standards, with no mention of AI or ML capabilities. The device offers pre-set programs and manual controls, which are typical for TENS/PMS devices and do not indicate AI/ML.
Yes
The device is intended to provide temporary relief of pain and improve/facilitate muscle performance, which are therapeutic uses.
No.
The device's intended use is for temporary pain relief and muscle stimulation, not for diagnosing conditions.
No
The device description explicitly states it is a "portable and DC 3.7V battery powered multifunction device" and details hardware components like an LCD display, intensity buttons, output ports, and includes accessories like electrode pads and cables. This indicates it is a physical hardware device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for pain relief and muscle stimulation through electrical pulses applied to the body's surface. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a device that delivers electrical stimulation via electrodes placed on the skin. This is consistent with a TENS/PMS device, not an IVD which would typically involve analyzing biological samples (blood, urine, tissue, etc.) outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a disease or condition.
Therefore, this device falls under the category of a therapeutic medical device, specifically a nerve and muscle stimulator, rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
TENS (Transcutaneous Electric Nerve Stimulation): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS (Powered Muscle Stimulation): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Product codes (comma separated list FDA assigned to the subject device)
NUH, NGX
Device Description
TENS and Muscle Stimulator is a portable and DC 3.7V battery powered multifunction device, offering both Transcutaneous Electrical Nerve Stimulation (TENS) and Powered Muscle Stimulation (PMS) qualities in one device.
TENS and Muscle Stimulator can give certain electrical pulses through electrode adhesive pads to the suggested area of the body where the electrodes are placed. AS8012 has 20 operation programs and AS8015 has 24 operation programs.
The electronic stimulatory module has the operating elements of an On/Off Switch, LCD display screen, Intensity buttons, Output channel buttons, T button, Output ports, and USB port for battery charging,etc.
The LCD display screen can show time remaining of an application program, battery power, program icons, output channel and intensity,etc.
The device is equipped with accessories of electrode pads, electrode cables a battery charger, and one USB cable. The electrode cables are used to connect the pads to the device; the USB cable is used to connect the charge and the built-in lithium battery. All accessories, including USB cables, electrode pads, electrode cables, chargers can only be changed or replaced by a qualified person.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, waist, back, 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 devices are safe and effective as the predicate devices and passed testing according to the safety standards:
- ANSI AAMI 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);
- IEC 60601-2-10 Edition 2.1 2016-04, Medical Electrical Equipment - Part 2-10: Particular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators;
- ANSI AAMI IEC 60601-1-2:2014, Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances --Requirements And Tests;
- IEC 62133-2 Edition1.0 2017-02 Secondary Cells And Batteries Containing Alkaline Or Other Non-Acid Electrolytes - Safety Requirements For Portable Sealed Secondary Cells, And For Batteries Made From Them, For Use In Portable Applications - Part 2: Lithium Systems
- IEC 60601-1-11 Edition 2.0 2015-01, 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 . (General II (ES/EMC))
The conclusion drawn from the safety testing is that the new devices are substantially equivalent to the predicate devices. Furthermore, the new devices comply with the recognized standards and perform its intended tasks as well as the legally marketed predicate devices.
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 18, 2020
Shenzhen As Tec Technology Co., Ltd % Doris Dong Manager Shanghai CV Technology Co., Ltd Room 903, No. 19 Dongbao Road, Songjiang Area Shanghai, China 201613
Re: K200727
Trade/Device Name: TENS and Muscle Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: March 10, 2020 Received: March 20, 2020
Dear Ms. Dong:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmr/pmn.cfm identifies combination product submissions. The general controls provisions of the Actinclude 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Pamela Scott Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200727
Device Name
TENS and Muscle Stimulator (Model AS8012 & AS8015)
Indications for Use (Describe)
TENS (Transcutaneous Electric Nerve Stimulation):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS (Powered Muscle Stimulation):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
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) |
_ | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
[As required by 21 CFR 807.92]
1. Submission Information:
| 510(k) Number: | K200727 |
|---|---|
| Date: | December 27, 2019 |
| Type of 510(k) Submission: | Traditional |
| Basis for 510(k) Submission: | New device |
| Submitter/Manufacturer: | Shenzhen As-Tec Technology Co., Ltd. |
| 8E XinBaoYi Industrial Bld, Houting Village Beiting Road, Shajing | |
| Shenzhen Guangdong, CHINA 518012 | |
| Contact: | Doris Dong |
| [Consultant, from Shanghai CV Technology Co., Ltd.] | |
| Add: Room 903, No. 19 Dongbao Road, Songjiang Area, Shanghai, 201613 China | |
| E-mail: doris_d@126.com | |
| Tel: 86 21-31261348 / Fax: 86 21-57712250 |
| 2. Device Description: | |
|---|---|
| Proprietary Name: | TENS and Muscle Stimulator (Model AS8012, AS8015) |
| Common Name: | TENS & PMS |
| Classification Name: | Stimulator, nerve, transcutaneous, over-the-counter, Stimulator, muscle, powered, for muscle conditioning |
| Regulation Number: | 882.5890, 890.5850 |
| Product Code: | NUH, NGX |
| Device Class: | II |
| Review Panel: | Neurology & Physical Medicine |
| Device Description: | TENS and Muscle Stimulator is a portable and DC 3.7V battery powered multifunction device, offering both Transcutaneous Electrical Nerve Stimulation (TENS) and Powered Muscle Stimulation (PMS) qualities in one device. |
| TENS and Muscle Stimulator can give certain electrical pulses through electrode adhesive pads to the suggested area of the body where the electrodes are placed. AS8012 has 20 operation programs and AS8015 has 24 operation programs. | |
| The electronic stimulatory module has the operating elements of an On/Off Switch, LCD display screen, Intensity buttons, Output channel buttons, T button, Output ports, and USB port for battery charging,etc. | |
| The LCD display screen can show time remaining of an application program, battery power, program icons, output channel and intensity,etc. | |
| The device is equipped with accessories of electrode pads, electrode cables a battery charger, and one USB cable. The electrode cables are used to connect the pads to the device; the USB cable is used to connect the charge and the built-in lithium battery. All accessories, including USB cables, |
4
| | electrode pads, electrode cables, chargers can only be changed or replaced
by a qualified person. |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use: | TENS ( Transcutaneous Electric Nerve Stimulation ):
To be used for temporary relief of pain associated with sore and aching
muscles in the shoulder, waist, back, upper extremities (arm), and lower
extremities (leg) due to strain from exercise or normal household work
activities. |
| | PMS ( Powered Muscle Stimulation ): |
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
5
3. Substantial Equivalence to Predicate device:
Detailed comparison data is included in "Section 10.1 - Substantial Equivalence Discussion" of this 510(k) submission.
Table 1 -
| Parameters | New Device | Predicate Device | Same/Different | ||
|---|---|---|---|---|---|
| 1. | 510(k) Number | Unassigned | K143268 | ||
| 2. | Marketing clearance | ||||
| date | / | 07/21/2015 | |||
| 3. | Device Name | TENS and Muscle | |||
| Stimulator | TENS AND POWERED | ||||
| MUSCLE STIMULATOR | |||||
| 4. | Model | AS8012 | N/A | ||
| 5. | Manufacturer | Shenzhen As-Tec | |||
| Technology Co., Ltd. | Shenzhen As-Tec | ||||
| Technology Co., Ltd. | SE | ||||
| 6. | Intended use | TENS (Program 3, 4, 8, | |||
| 9,12, 13, 14, 15, 17, 18, 19, | |||||
| 20): | |||||
| To be used for temporary | |||||
| relief of pain associated with | |||||
| sore and aching muscles in | |||||
| the shoulder, waist, back, | |||||
| upper extremities (arm), and | |||||
| lower extremities (leg) due | |||||
| to strain from exercise or | |||||
| normal household work | |||||
| activities. | |||||
| PMS (Program 1, 2, 5, 6, 7, | |||||
| 10, 11, 16): | |||||
| It is intended to be used to | |||||
| stimulate healthy muscles in | |||||
| order to improve and | |||||
| facilitate muscle | |||||
| performance. | TENS (Mode 1, 3, 4, 5, 6): | ||||
| To be used for temporary | |||||
| relief of pain associated with | |||||
| sore and aching muscles in | |||||
| the shoulder, waist, back, | |||||
| upper extremities (arm), and | |||||
| lower extremities (leg) due | |||||
| to strain from exercise or | |||||
| normal household work | |||||
| activities. | |||||
| PMS (Mode 1, 2, 3, 5): | |||||
| It is intended to be used to | |||||
| stimulate healthy muscles in | |||||
| order to improve and | |||||
| facilitate muscle | |||||
| performance. | Same | ||||
| Note 1 | |||||
| 7. | Type of use | OTC | OTC | Same | |
| 7.8 | Power Source(s) | DC 3.7V lithium battery | DC 3.7V lithium battery | Same | |
| - Method of Line | |||||
| Current Isolation | Type BF | Type BF | Same | ||
| - Patient Leakage | |||||
| Current | -- | -- | Same | ||
| - Normal | |||||
| Condition (μΑ) | 0.1μΑ | 0.1μΑ | |||
| - Single Fault | |||||
| Condition (μΑ) | 0.1μΑ | 0.1μΑ | |||
| 9. | Average DC current | ||||
| through electrodes | |||||
| when device is on |