(151 days)
TENS & EMS STIMULATOR has two functions and can be used for arm, shoulder, neck, back, waist, abdomen, hip, and leg.
TENS: It is used for the symptomatic relief of chronic intractable pain and the temporary relief of pain associated with sore and aching muscles in the arm, shoulder, neck, back, waist, abdomen, hip and leg due to strain from exercise or normal household and work activities.
EMS: It is used for relaxation of muscle spasm, increase of local blood flow circulation, prevention of disuse atrophy, muscle re-education, maintaining or increasing range of motion, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Not Found
The provided document is an FDA 510(k) clearance letter for a TENS&EMS STIMULATOR device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of a medical device.
The letter primarily covers:
- Device Name: TENS&EMS STIMULATOR (Models: KRES-100D, KRES-1010, KRES-1020, KRES-1080)
- Regulation Number and Name: 21 CFR 882.5890, Transcutaneous Electrical Nerve Stimulator For Pain Relief
- Regulatory Class: Class II
- Product Codes: NUH, NGX, IPF
- Substantial Equivalence Determination: The FDA has determined the device is substantially equivalent to legally marketed predicate devices.
- General Controls Provisions: Mentions requirements for registration, listing, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
- Indications for Use: Detailed descriptions of TENS and EMS functions for pain relief, muscle spasm relaxation, blood flow circulation, muscle re-education, etc.
- Prescription/Over-The-Counter Use: X Over-The-Counter Use.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided text.
A 510(k) clearance letter indicates that the FDA has reviewed the manufacturer's submission and found the device to be substantially equivalent to a predicate device. The detailed performance data and the specific studies conducted to demonstrate this equivalence (like clinical trials or performance testing against acceptance criteria) are part of the manufacturer's 510(k) submission, which is not included in this public clearance letter.
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May 6, 2022
Dongguan Bohuikang Technology Co., Ltd. % Jett Lee Official Correspondent Guangdong Jianda Medical Technology Co., Ltd. 906 Room, Longxiang Garden, Tianhe District Guangzhou, Guangdong 510000 China
Re: K213788
Trade/Device Name: TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX, IPF Dated: November 25, 2021 Received: December 6, 2021
Dear Jett 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 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 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.
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) K213788
Device Name
TENS&EMS STIMULATOR (Model: KRES-100D, KRES-1010, KRES-1020, KRES-1080)
Indications for Use (Describe)
TENS & EMS STIMULATOR has two functions and can be used for arm, shoulder, neck, back, waist, abdomen, hip, and leg.
TENS: It is used for the symptomatic relief of chronic intractable pain and the temporary relief of pain associated with sore and aching muscles in the arm, shoulder, neck, back, waist, abdomen, hip and leg due to strain from exercise or normal household and work activities.
EMS: It is used for relaxation of muscle spasm, increase of local blood flow circulation, prevention of disuse atrophy, muscle re-education, maintaining or increasing range of motion, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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§ 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).