The Pain Therapy Device (Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I): TENS: - For relief of pain and management of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise, work or normal household work activities by applying transcutaneous electrical current to stimulate the nerves. - For relief of pain associated with arthritis. - For symptomatic relief and management of chronic intractable pain EMS: - To stimulate healthy muscles in order to improve and facilitate muscle performance. - To temporarily increase local blood circulation in healthy muscles. NMES: - For relaxation of muscle spasm. - Increase of blood flow circulation. - Prevention or retardation of disuse muscle atrophy. - Muscle re-education. - Maintaining or increasing range of motion. - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. - For Users with conditions or diseases that are associated with impaired (poor) blood flow in the legs/ankle/feet. NMES through the foot electrodes is intended to use as an adjunctive treatment (as an additional treatment to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping.

Device Description

Not Found

AI/ML Overview

This document is a marketing clearance letter from the FDA for a Pain Therapy Device (models DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I).

It is NOT a report or study that details acceptance criteria and device performance. The letter states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, which means it clears the device for marketing. However, it does not provide details of specific performance testing, clinical study results, or the methodology (sample size, expert qualifications, etc.) used to establish performance.

Therefore, I cannot provide the requested information because the provided text does not contain:

A table of acceptance criteria and reported device performance: This document does not describe specific performance metrics or their acceptable thresholds.
Sample size used for the test set and data provenance: There is no mention of a test set, its size, or the origin of any data.
Number of experts used to establish ground truth and their qualifications: No information about expert involvement in establishing ground truth is present.
Adjudication method for the test set: No test set means no adjudication method is discussed.
Multi-reader multi-case (MRMC) comparative effectiveness study: This is not a study report, so no MRMC study details are provided.
Standalone (algorithm only) performance: This device is a physical electromedical device, not an AI algorithm.
Type of ground truth used: Not applicable as this is not a study of an AI or diagnostic device.
Sample size for the training set: Not applicable; this is a hardware device.
How ground truth for the training set was established: Not applicable.

The document is solely an FDA clearance letter based on substantial equivalence to existing devices, not a detailed technical or clinical performance report.

Summary

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November 1, 2021

Guangzhou Xinbo Electronic Co., Ltd. % Cassie Lee Official Correspondent Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road Huangpu District Guangzhou, Guangdong 511400 China

Re: K212948

Trade/Device Name: Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX, NUH, IPF, NYN, GZJ Dated: September 14, 2021 Received: September 16, 2021

Dear Cassie Lee:

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

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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 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 Heather Dean, PhD Assistant Director, Acute Injury Devices Team 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) K212948

Device Name

The Pain Therapy Device (Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I)

Indications for Use (Describe)

The Pain Therapy Device (Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I): TENS:

For relief of pain and management of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise, work or normal household work activities by applying transcutaneous electrical current to stimulate the nerves.
For relief of pain associated with arthritis.
For symptomatic relief and management of chronic intractable pain

EMS:

To stimulate healthy muscles in order to improve and facilitate muscle performance.
To temporarily increase local blood circulation in healthy muscles.

NMES:

For relaxation of muscle spasm.
Increase of blood flow circulation.
Prevention or retardation of disuse muscle atrophy.
Muscle re-education.
Maintaining or increasing range of motion.
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
For Users with conditions or diseases that are associated with impaired (poor) blood flow in the legs/ankle/feet. NMES through the foot electrodes is intended to use as an adjunctive treatment (as an additional treatment to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping.

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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Regulation Number and Section

§ 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).