(333 days)
Not Found
No
The document describes a standard TENS/PMS device with wireless control and a mobile app. There is no mention of any adaptive algorithms, data analysis for personalized treatment, or other features typically associated with AI/ML. The device simply offers pre-set modes.
Yes.
The device is intended for "temporary relief of pain associated with sore and aching muscles" and "to stimulate healthy muscles in order to improve and facilitate muscle performance," which are therapeutic applications.
No
The device is described as a TENS and PMS unit, intended for temporary pain relief and muscle stimulation, not for diagnosing medical conditions.
No
The device description explicitly states that the device is a "portable battery powered device" with a "round main unit" or "butterfly-shaped main unit" and includes components like electrode pads/gels, chargers, and USB cables. While one model is controlled by a mobile app, the core functionality and delivery of the therapy (electrical stimulation) are performed by physical hardware components.
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, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a TENS and PMS device that applies electrical current to electrodes on a patient's skin. It is used for pain relief and muscle stimulation.
- Intended Use: The intended use is for temporary pain relief and muscle stimulation, not for analyzing biological samples.
The device operates externally on the body and does not involve the analysis of in vitro specimens.
N/A
Intended Use / Indications for Use
Model SM9187:
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, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS (Mode 1, 2, 3, 4, 5, 6):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Model SM9180L & SM9180S:
TENS (Mode 1, 3, 4, 5, 6):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, back due to strain from exercise or normal household work activities.
PMS (Mode 1, 2, 3, 4, 5, 6):
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
Sunmas TENS & PMS (Model SM9187, SM9180L & SM9180S) is a portable battery powered device with a wireless feature for over-the-counter use, offering both Transcutaneous Electrical Nerve Stimulation (TENS) and Powered Muscle Stimulation (PMS) qualities in one device. Sunmas TENS & PMS has totally 6 modes, applying electrical current to electrodes on a patient's skin to relieve pain or build up muscle. Due to different electrode shapes and sizes, Model SM9187 can be used on the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (legs), while Model SM9180L and SM9180S can be used on the shoulder, back and abdomen. Model SM9187 is designed to be controlled by a mobile phone application program (APP) named “Dr.Stim”, through Bluetooth 4.0 technology (Frequency: 2402.0 - 2480.0MHz). The APP is developed by Hong Qiangxing (Shenzhen) electronics Limited. SM9187 consists of a round main unit, two sets of self-adhesive electrode pad, a mobile application (APP), an AC charger and a USB cable. Model SM9180L and SM9180S both have a butterfly-shaped main unit (Frequency: 2450MHz) and can be remotely controlled through wireless technology. SM9180L has a black remote control with an electronic display screen which is powered by two AAA alkaline batteries, while SM9180S has a white remote control powered by a CR2032 coin battery. The radio frequency of remote control (both black and white) is 2405.0 - 2470.0MHz. Model SM9180L and SM9180S consists of a unit, two pairs of electrode gels, a remote control (black or white), an AC charger and a USB cable.
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), lower extremities (leg), abdomen
Indicated Patient Age Range
Adult
Intended User / Care Setting
Over-The-Counter Use
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 new device has 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 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)];
- 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));
- FCC 47 CFR Part 15 RADIO FREQUENCY DEVICES;
- AAMI TIR69: 2017 Technical Information Report Risk Management Of Radio-Frequency Wireless Coexistence For Medical Devices And Systems;
- ANSI IEEE C63.27-2017 American National Standard For Evaluation Of Wireless Coexistence.
Key Results: The conclusion drawn from the safety testing is that the new device is 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): 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).
0
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which stands for U.S. Food & Drug Administration. The FDA logo is in blue.
December 2, 2019
Hong Qiangxing (Shen Zhen) Electronics Limited % Doris Dong Manager Shanghai CV Technology Co., Ltd. Room 903, No. 19 Dongbao Road, Songjiang Area Shanghai, 201613 China
Re: K190009
Trade/Device Name: Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: November 27, 2018 Received: January 3, 2019
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 Vivek Pinto, Ph.D. Acting Division Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190009
Device Name
Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)
Indications for Use (Describe) Model SM9187:
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, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS (Mode 1, 2, 3, 4, 5, 6):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Model SM9180L & SM9180S:
TENS (Mode 1. 3. 4. 5. 6):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, back due to strain from exercise or normal household work activities.
PMS (Mode 1, 2, 3, 4, 5, 6):
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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
[As required by 21 CFR 807.92]
1. Submission Information:
| 510(k) Number: | K190009 |
|---|---|
| Date: | December 12, 2019 |
| 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: | Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) |
| 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: | Sunmas TENS & PMS (Model SM9187, SM9180L & SM9180S) is a |
| portable battery powered device with a wireless feature for over-the-counter | |
| use, offering both Transcutaneous Electrical Nerve Stimulation (TENS) and | |
| Powered Muscle Stimulation (PMS) qualities in one device. | |
| Sunmas TENS & PMS has totally 6 modes, applying electrical current | |
| to electrodes on a patient's skin to relieve pain or build up muscle. | |
| Due to different electrode shapes and sizes, Model SM9187 can be | |
| used on the shoulder, waist, back, neck, upper extremities (arm), and lower | |
| extremities (legs), while Model SM9180L and SM9180S can be used on the | |
| shoulder, back and abdomen. | |
| Model SM9187 is designed to be controlled by a mobile phone | |
| application program (APP) named “Dr.Stim”, through Bluetooth 4.0 | |
| technology (Frequency: 2402.0 - 2480.0MHz). The APP is developed by | |
| Hong Qiangxing (Shenzhen) electronics Limited. SM9187 consists of a | |
| round main unit, two sets of self-adhesive electrode pad, a mobile | |
| application (APP), an AC charger and a USB cable. | |
| Model SM9180L and SM9180S both have a butterfly-shaped main unit | |
| (Frequency: 2450MHz) and can be remotely controlled through wireless | |
| technology. SM9180L has a black remote control with an electronic display | |
| screen which is powered by two AAA alkaline batteries, while SM9180S |
4
has a white remote control powered by a CR2032 coin battery. The radio frequency of remote control (both black and white) is 2405.0 - 2470.0MHz. Model SM9180L and SM9180S consists of a unit, two pairs of electrode gels, a remote control (black or white), an AC charger and a USB cable. Model SM9187:
Indications for use:
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, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS (Mode 1, 2, 3, 4, 5, 6):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Model SM9180L & SM9180S:
TENS (Mode 1, 3, 4, 5, 6):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, back due to strain from exercise or normal household work activities.
PMS (Mode 1, 2, 3, 4, 5, 6):
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:
Table 1 -
| Parameters | New Device | Predicate Device 1 | Predicate Device 2 | ||
|---|---|---|---|---|---|
| 1. | 510(k) Number: | K190009 | K121719 | K143430 | |
| 2. | Marketing clearance date: | May 10, 2013 | May 10, 2013 | May 29, 2015 | |
| 3. | Device Name | SM9187 | SM TENS & PMS | SmartTENS | |
| 4. | Manufacturer | Hong Qiangxing (Shenzhen) Electronics Limited | Hong Qiangxing (Shenzhen) Electronics | ||
| Limited | EasyMed Instruments Co., Ltd. | ||||
| 5. | Product code | NUH, NGX | NGX, NUH | NUH | |
| 6. | Accessories | Self-adhesive electrodes, Battery charger, USB cable | Self-adhesive electrodes, electrode wires, Battery | ||
| charger, USB cable | Button-affixed electrode, Replaceable Hydrogel | ||||
| Pads( (gel-pads) )73mm x 62mm, charger cradle, | |||||
| charging adapter | |||||
| 7. | Intended use | 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, neck, upper extremities (arm), and | |||||
| lower extremities (leg) due to strain from exercise | |||||
| or normal household work activities. | |||||
| PMS (Mode 1, 2, 3, 4, 5, 6): | |||||
| 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, neck, upper extremities (arm), and | |||||
| lower extremities (leg) due to strain from exercise | |||||
| or normal household work activities. | |||||
| PMS (Mode 1, 2, 3, 6): | |||||
| It is intended to be used to stimulate healthy | |||||
| muscles in order to improve and facilitate muscle | |||||
| performance. | 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. | |||||
| 8. | Target Population | Adult | Adult | Adult | |
| 9. | Type of use | OTC | OTC | OTC | |
| 10. | Wireless Control | Yes(Bluetooth device controlled by Application) | No | Yes(Bluetooth device controlled by Application) | |
| 11. | Number of Output Modes | 6 | 6 | 7 | |
| 12. | Number of Output channels: | 1 | 2 | 1 | |
| - Synchronous or | NA | Synchronous | NA | ||
| Alternating? | |||||
| - Method of Channel | NA | Voltage transformer Isolation | NA | ||
| Isolation | |||||
| 13. | Waveform (e.g. pulsed | Biphasic rectangular | Biphasic rectangular | Biphasic rectangular | |
| monophasic, biphasic) | Monophasic rectangular | Monophasic rectangular | Monophasic rectangular | ||
| 14. | Power Source(s) | 3.7V rechargeable lithium battery | 3.7V rechargeable lithium battery | 3.7V rechargeable lithium battery | |
| - Method of Line Current | Type BF | Type BF | Type BF | ||
| Isolation | |||||
| - Patient Leakage Current | -- | -- | -- | ||
| - Normal Condition (μΑ) |