(90 days)
Not Found
Not Found
No
The provided text only describes the intended use of TENS and PMS devices for pain relief and muscle stimulation. There is no mention of AI or ML technology in the intended use, device description, or any other section of the summary.
Yes.
The device descriptions indicate that it provides "temporary relief of pain associated with sore and aching muscles" and is "intended to be used to stimulate healthy muscles," which are therapeutic applications.
No
The provided text describes the devices as being for "temporary relief of pain" (TENS) and to "stimulate healthy muscles" (PMS), which are therapeutic uses, not diagnostic.
No
The provided text only describes the intended use and indications for use of several devices (SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033). These indications are for TENS and PMS, which are physical stimulation therapies. The text does not contain a device description, and the nature of TENS and PMS therapies inherently involves hardware (electrodes, stimulator unit) to deliver electrical impulses. Therefore, these are not software-only devices.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use for all listed devices (SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033) is for temporary relief of pain associated with sore and aching muscles (TENS) and to stimulate healthy muscles to improve and facilitate muscle performance (PMS). These are therapeutic and physical stimulation applications.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions.
- Lack of IVD Characteristics: The provided information does not mention any analysis of biological specimens, diagnostic purposes, or any of the typical characteristics of an IVD.
These devices appear to be electrical muscle stimulators or TENS/PMS devices, which are used externally on the body for pain relief and muscle stimulation, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
SM9009:
TENS(1-7,9,10,14,16,19,21,22,24):
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(8,11,12,13,15,17,18,20,23):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
SM9021:
TENS(3-6,8-11,15,16,19,21):
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(1,2,7,12,13,14,17,18,20,22,23,24):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
SM9128H:
TENS(2-6,9,11,14,16,19,21,22,24):
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(1,7,8,10,12,13,15,17,18,20,23):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
SM9015:
TENS(2-4.8.9.10.12.13.14.15.17.18.19.20.22):
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(1.5,6.7,11,16,21,23,24):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
SM9055:
TENS(1-8,10,11,13,14,16,19,21-25,30,31,35,36):
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(9,12,15,17,18,20,26,27,28,29,32,33,34):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
SM9033:
TENS(1-16,19,21,22):
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(17,18,20,23,24):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Product codes
NGX, NUH
Device Description
Not Found
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)
Not Found
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.
Not Found
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym with the full name of the agency on the right. The FDA part is in blue, with the acronym in a solid blue square and the full name written in a smaller font next to it.
May 2, 2022
Hong Qiangxing (Shen Zhen) Electronics Limited % Doris Dong General Manager Shanghai CV Technology Co., Ltd. Room 903, No.19 Dongbao Road, Songjiang Area, Shanghai 201613 China
Re: K220283
Trade/Device Name: TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX. NUH Dated: January 24, 2022 Received: February 1, 2022
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,
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220283
Device Name
TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)
Indications for Use (Describe) SM9009:
TENS(1-7,9,10,14,16,19,21,22,24):
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(8,11,12,13,15,17,18,20,23):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
SM9021:
TENS(3-6,8-11,15,16,19,21):
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(1,2,7,12,13,14,17,18,20,22,23,24):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
SM9128H:
TENS(2-6,9,11,14,16,19,21,22,24):
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(1,7,8,10,12,13,15,17,18,20,23):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
SM9015:
TENS(2-4.8.9.10.12.13.14.15.17.18.19.20.22):
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(1.5,6.7,11,16,21,23,24):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
SM9055:
TENS(1-8,10,11,13,14,16,19,21-25,30,31,35,36):
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(9,12,15,17,18,20,26,27,28,29,32,33,34):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
SM9033:
TENS(1-16,19,21,22):
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(17,18,20,23,24):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
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Prescription Use (Part 21 CFR 801 Subpart D)
- X Over-The-Counter Use (21 CFR 801 Subpart C)
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