(86 days)
The Air Compression Leg Massager is indicated for the temporary relief of minor muscle aches and for temporary increase in circulation to the treated areas in people who are in good health. The Air Compression Leg Massager simulates kneading and stroking of tissues by using an inflatable garment.
Air Compression Leg Massager (Model: LY-670D)
This document is a 510(k) clearance letter from the FDA for a medical device called "Air Compression Leg Massager (Model: LY-670D)". It states that the device is substantially equivalent to legally marketed predicate devices.
The information provided describes the regulatory classification and indications for use of the device. However, it does not contain any details about acceptance criteria or a study that proves the device meets specific performance criteria.
The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive de novo clinical performance studies with specific statistical acceptance criteria for novel claims. For devices like this, the "study" demonstrating substantial equivalence likely involved a comparison of design, materials, performance specifications (e.g., pressure, cycle times), and intended use to an already cleared device.
Therefore,Based on the provided document, I cannot answer your request as the information about acceptance criteria and a study proving the device meets these criteria is not present in the FDA 510(k) clearance letter.
The 510(k) process for a device like an Air Compression Leg Massager typically relies on demonstrating substantial equivalence to a predicate device rather than presenting extensive performance studies with specific statistical acceptance criteria as would be seen for a novel diagnostic AI algorithm, for example.
The document states: "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..."
This means the "proof" the device meets requirements is its similarity to a legally marketed device that the FDA has already deemed safe and effective for similar indications. The specific details you are asking for (e.g., sample size, expert ground truth, adjudication methods, MRMC studies, effect sizes, standalone performance, training set details) are typically found in submissions for more complex or novel devices, especially those involving AI/ML components for diagnostic or prognostic purposes, or those undergoing a De Novo classification.
The provided text only covers the regulatory clearance and the device's intended use (temporary relief of minor muscle aches and temporary increase in circulation).
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December 22, 2022
Zhejiang Luyao Electronics Technology Co., Ltd % Reanny Wang General Manager Shenzhen Reanny Medical Devices Management Consulting Co Ltd Room 1407, Jinging Building, Dongzhou Community Guangming Street, Guangming District Shenzhen, Guangdong 518000 China
Re: K222949
Trade/Device Name: Air Compression Leg Massager (Model: LY-670D) Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: November 2, 2022 Received: November 2, 2022
Dear Reanny Wang:
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 L. Dean -S
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) K222949
Device Name
Air Compression Leg Massager (Model: LY-670D)
Indications for Use (Describe)
The Air Compression Leg Massager is indicated for the temporary relief of minor muscle aches and for temporary increase in circulation to the treated areas in people who are in good health. The Air Compression Leg Massager simulates kneading and stroking of tissues by using an inflatable garment.
| 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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§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).