Combo Electrotherapy Device

• K Number: K192087
• Device Name: Combo Electrotherapy Device
• Manufacturer: Shenzhen Roundwhale Technology Co., Ltd.
• Date Cleared: 2019-11-01 ( 88 days)
• Product Code: NUH , GZJ , IPF , NGX
• Regulation Number: 882.5890
• Type: Traditional
• Panel: Neurology
• Reference & Predicate Devices: N/A
• Predicate For: K231423

Intended Use

Over-The-Counter Use:

TENS mode::

It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.

EMS mode:

This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

Prescription Use:

For TENS mode:

• 1. Symptomatic relief of chronic intractable pain:
• 2. Post traumatic pain: 3) Post surgical pain;

For EMS mode:

• 1. Relaxation of muscle spasm;
• 2. Increase of local blood flow circulation;
• 3. Prevention or retardation of disuse atrophy;
• 4. Muscle re-education;
• 5. Maintaining or increasing range of motion;
• 6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a Combo Electrotherapy Device. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the way a clinical study report for an AI/ML device would. The letter primarily confirms the device's substantial equivalence to predicate devices and lists the indications for use.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies from the provided text. This document is a regulatory clearance, not a performance study report.

Summary

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November 4, 2019

Shenzhen Roundwhale Technology Co., Ltd. Kevin Zhang General Manager 202, 2/F, Building 27, Dafa Industrial Park, Longxi Community, Longgang Street Shenzhen, GuangDong, China 518108

Re: K192087

Trade/Device Name: Combo Electrotherapy Device Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NUH, NGX, IPF, GZJ Dated: July 28, 2019 Received: August 5, 2019

Dear Kevin Zhang:

This letter corrects our substantially equivalent letter of November 1, 2019.

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 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.

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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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Amber T. Ballard -S

For Vivek Pinto, Ph.D. Director (Acting) 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) K192087

Device Name Combo Electrotherapy Device

Indications for Use (Describe) Over-The-Counter Use:

TENS mode::

It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.

EMS mode:

This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

Prescription Use:

For TENS mode:

• 1. Symptomatic relief of chronic intractable pain:
• 2. Post traumatic pain: 3) Post surgical pain;

For EMS mode:

• 1. Relaxation of muscle spasm;
• 2. Increase of local blood flow circulation;
• 3. Prevention or retardation of disuse atrophy;
• 4. Muscle re-education;
• 5. Maintaining or increasing range of motion;
• 6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

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

§ 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).