(204 days)
Not Found
No
The document describes a standard TENS/PMS device and its intended uses. There is no mention of AI, ML, or any features that would suggest the use of such technologies. The performance studies focus on electrical safety and performance standards, not algorithmic validation.
Yes
The device is intended for "temporary relief of pain associated with sore and aching muscles" (TENS) and "to stimulate healthy muscles in order to improve and facilitate muscle performance" (PMS), which are therapeutic uses.
No
Explanation: The device is intended for pain relief and muscle stimulation, not for identifying the presence or nature of a disease or condition.
No
The device description explicitly states it is a "portable and DC 3.7V battery powered multifunction device" and includes physical accessories like electrode pads, cables, and a charger. This indicates it is a hardware device, not software-only.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for temporary relief of pain and muscle stimulation. These are therapeutic applications performed directly on the body.
- Device Description: The description details a portable electrical stimulation device with electrodes applied to the skin. This is consistent with a device used for physical therapy or pain management, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
In vitro diagnostics are devices used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device operates externally on the body for therapeutic purposes.
N/A
Intended Use / Indications for Use
Device Name TENS & PMS
| Model: | SM9079 |
|---|---|
| TENS | (1,3,4,5,6,21): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. |
| PMS | (2,7,8,9,10,11,12,13,14,15,16,17,18,19,20,22,23,24): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. |
| Model: | SM9126 |
|---|---|
| TENS | (3,4,5,6,11,12,16): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. |
| PMS | (1,2,7,8,9,10,13,14,15): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. |
| Model: | SM9186 |
|---|---|
| TENS | (3,4,7,8,11): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. |
| PMS | (1,2,5,6,9,10,12): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. |
| Model: | SM9196 |
|---|---|
| TENS | (10~15): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. |
| PMS | (1~9): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. |
Product codes
NGX, NUH
Device Description
TENS & PMS is a portable and DC 3.7V battery powered multifunction device with multiple models, offering both Transcutaneous Electrical Nerve Stimulation (TENS) and Powered Muscle Stimulation (PMS) qualities in one device.
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 charger 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, 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)
TENS & PMS are safe and effective as the predicate devices cited above. The new devices have passed testings according to the following 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:
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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;
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IEC 62133 Edition 2.0 2012-12, IEC 62133 Edition 2.0 2012-12 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 [Including: Corrigendum 1 (2013)]:
-
ANSI AAMI HA60601-1-11 2015 Medical Electrical Equipment -- Part 1-11: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment (IEC 60601-1-11:2015 MOD);
The conclusion drawn from the testings are that the new devices are substantially equivalent to the predicate device. Furthermore, the new device complies with the recognized standards and performs its intended tasks as well as the legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.
December 11, 2020
Hong Qiangxing (Shen Zhen) Electronics Limited % Doris Dong Manager Shanghai CV Technology Co., Ltd. Room 903, No. 19 Dongbao Road, Songjiang Area Shanghai, Shanghai 201613 China
Re: K201354
Trade/Device Name: TENS & PMS Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: NGX. NUH Dated: September 3, 2020 Received: September 14, 2020
Dear Doris 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/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 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-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 Advice (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,
For Amber Ballard, PhD 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
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Indications for Use
510(k) Number (if known) K201354
Indications for Use (Describe)
Device Name TENS & PMS
| Model: | SM9079 |
|---|---|
| TENS | (1,3,4,5,6,21): |
| To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. | |
| PMS | (2,7,8,9,10,11,12,13,14,15,16,17,18,19,20,22,23,24): |
| It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. | |
| Model: | SM9126 |
| TENS | (3,4,5,6,11,12,16): |
| To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. | |
| PMS | (1,2,7,8,9,10,13,14,15): |
| It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. | |
| Model: | SM9186 |
| TENS | (3,4,7,8,11): |
| To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. | |
| PMS | (1,2,5,6,9,10,12): |
| It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. | |
| Model: | SM9196 |
| TENS | (10~15): |
| To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. | |
| PMS | (1~9): |
| 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) |
|---|---|
| ----------------------------------------------------------------------- | --------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen City, Guangdong, China 518126
510(k) Summary
[As required by 21 CFR 807.92]
1. Submission Information:
| 510(k) Number: | K201354 |
|---|---|
| Date: | December 11, 2020 |
| Type of 510(k) Submission: | Traditional |
| Basis for 510(k) Submission: | New device |
| Submitter/Manufacturer: | Hong Qiangxing(Shen Zhen) Electronics Limited |
| 4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an | |
| District, Shenzhen City, Guangdong, China 518126 | |
| 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 & PMS |
| Common Name: | TENS & PMS |
| Classification Name: | Powered muscle stimulator |
| Transcutaneous electrical nerve stimulator for pain relief | |
| Regulation Number: | 21 CFR 890.5850, 21 CFR 882.5890 |
| Product Code: | NGX, NUH |
| Device Class: | II |
| Review Panel: | Neurology & Physical Medicine |
| Device Description: | TENS & PMS is a portable and DC 3.7V battery powered multifunction |
| device with multiple models, offering both Transcutaneous Electrical Nerve | |
| Stimulation (TENS) and Powered Muscle Stimulation (PMS) qualities in | |
| one device. | |
| 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 charger | |
| 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. | |
| Indications for use: | Model: SM9079 |
| TENS(1,3,4,5,6,21): | |
| To be used for temporary relief of pain associated with sore and aching | |
| muscles in the shoulder, waist, back, neck, upper extremities (arm), and | |
| lower extremities (leg) due to strain from exercise or normal household | |
| work activities. | |
| PMS(2,7,8,9,10,11,12,13,14,15,16,17,18,19,20,22,23,24): | |
| It is intended to be used to stimulate healthy muscles in order to improve | |
| and facilitate muscle performance. |
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4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen City, Guangdong, China 518126
Model: SM9126
TENS(3.4.5.6.11.12.16):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS(1,2,7,8,9,10,13,14,15):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Model: SM9186
TENS(3,4,7,8,11):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS(1,2,5,6,9,10,12):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Model: SM9196
TENS(10~15):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS(1~9):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
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4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen City, Guangdong, China 518126 3. Working principle
The device uses electrodes to send a specific electric current to the skin. TENS(Transcutaneous electrical nerve stimulation) mode is to relieve pain using electrical stimulation. PMS(Powered Muscle Stimulation) mode is to stimulate healthy muscles in order to improve performance by electrical stimulation.
4. Substantial Equivalence to Predicate device: Basic Unit Characteristics
Table 1-
| Parameters | New Device | Predicate Device | Remark | |
|---|---|---|---|---|
| 510(k) Number | K201354 | K121719 | -- | |
| Device Name | TENS & PMS | SM TENS & PMS | -- | |
| Model | SM9079 | No | -- | |
| Manufacturer | Hong Qiangxing (Shenzhen) | |||
| Electronics Limited | Hong Qiangxing (Shenzhen) | |||
| Electronics Limited | Same | |||
| Intended use | TENS(1,3~6,21): | |||
| To be used for temporary relief | ||||
| of pain associated with sore and | ||||
| aching muscles in the shoulder, | ||||
| waist, back, neck, upper | ||||
| extremities (arm), and lower | ||||
| extremities (leg) due to strain | ||||
| from exercise or normal | ||||
| household work activities. | ||||
| PMS(2,7 | ||||
| It is intended to be used to | ||||
| stimulate healthy muscles in | ||||
| order to improve and facilitate | ||||
| muscle performance. | TENS(1,3,4,5,6): | |||
| To be used for temporary relief | ||||
| of pain associated with sore and | ||||
| aching muscles in the shoulder, | ||||
| waist, back, neck, upper | ||||
| extremities (arm), and lower | ||||
| extremities (leg) due to strain | ||||
| from exercise or normal | ||||
| household work activities. | ||||
| PMS(1,2,3,6): | ||||
| It is intended to be used to | ||||
| stimulate healthy muscles | ||||
| in | ||||
| order to improve and facilitate | ||||
| muscle performance. | Same | |||
| Type of use | OTC | OTC | Same | |
| 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 | -- | Same | ||
| Current | ||||
| Normal |