(90 days)
Not Found
Not Found
No
The provided text describes TENS and PMS devices for pain relief and muscle stimulation, with no mention of AI or ML technology in the intended use, device description, or other sections.
Yes
The intended use clearly states that the device is "to be used 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 purposes.
No
The provided text describes the devices (SM9089, SM9587, SM9592, SM9555) as being used for "temporary relief of pain" (TENS) and to "stimulate healthy muscles" (PMS), which are therapeutic and performance-enhancing functions, not diagnostic ones. There is no mention of the device identifying, analyzing, or determining a medical condition.
No
The provided text only describes the intended use and indications for use of several devices (SM9089, SM9587, SM9592, SM9555) which are TENS and PMS devices. These types of devices typically involve hardware components that deliver electrical stimulation. The summary does not contain a device description or any information suggesting the device is solely software.
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 (SM9089, SM9587, SM9592, SM9555) 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 performance-enhancing uses, not diagnostic.
- IVD Definition: In Vitro Diagnostics are medical devices intended to perform tests on specimens taken from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Lack of Diagnostic Activity: The provided information does not mention any testing of biological samples or any diagnostic purpose. The devices are applied externally to the body to deliver electrical stimulation.
Therefore, these devices fall under the category of therapeutic or physical medicine devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
SM9089:
TENS(3,4,5,6,8,15,19,21):
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(1,2,7,9,10,11,12,13,14,16,17,18,20,22,23,24):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
SM9587:
TENS(3.4.5.6 8.11.15.16.19.21.22):
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(1,2,7,9,10,12,13,14,17,18,20,23,24):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
SM9592:
TENS(2,3,4,5,7,9,10,19,21,22,24):
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(1,6,8,11,12,13,14,15,16,17,18,20,23):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
SM9555:
TENS(3-6, 13,14,19-21,23):
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(1,2,7-12,15-18,22,24):
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
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
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)
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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
April 19, 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, Shanghai 201613 China
Re: K220152
Trade/Device Name: TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH, NGX Dated: January 11, 2022 Received: January 19, 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
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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 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) K220152
Device Name
TENS & PMS (Model: SM9089, SM9587, SM9592, SM9555)
Indications for Use (Describe) SM9089:
TENS(3,4,5,6,8,15,19,21):
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(1,2,7,9,10,11,12,13,14,16,17,18,20,22,23,24):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
SM9587:
TENS(3.4.5.6 8.11.15.16.19.21.22):
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(1,2,7,9,10,12,13,14,17,18,20,23,24):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
SM9592:
TENS(2,3,4,5,7,9,10,19,21,22,24):
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(1,6,8,11,12,13,14,15,16,17,18,20,23):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
SM9555:
TENS(3-6, 13,14,19-21,23):
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(1,2,7-12,15-18,22,24):
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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