Air Compression Therapy Device

K201694 · Shenzhen Dongjilian Electronics Co., Ltd. · IRP · Nov 19, 2020 · Physical Medicine

Device Facts

• Record ID: K201694
• Device Name: Air Compression Therapy Device
• Applicant: Shenzhen Dongjilian Electronics Co., Ltd.
• Product Code: IRP · Physical Medicine
• Decision Date: Nov 19, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Air Compression Therapy Device are 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 Therapy Device simulates kneading and stroking of tissues by using an inflatable garment.

Device Story

Air Compression Therapy Device is an over-the-counter, powered inflatable tube massager. It consists of an inflatable garment that applies pneumatic pressure to the user's limbs. The device operates by inflating and deflating chambers within the garment to simulate kneading and stroking of tissues. This mechanical action is intended to provide temporary relief of minor muscle aches and increase local circulation. The device is designed for home use by the patient. It does not involve complex software or AI algorithms; it functions as a mechanical pneumatic massager.

Clinical Evidence

No clinical data provided; device relies on technological characteristics and intended use similarities to legally marketed devices.

Technological Characteristics

Powered inflatable tube massager (21 CFR 890.5650). Operates via pneumatic inflation/deflation of garment chambers to provide mechanical massage. Class II device. Product code: IRP.

Indications for Use

Indicated for healthy individuals seeking temporary relief of minor muscle aches and temporary increase in circulation to treated areas via simulated kneading and stroking of tissues.

Regulatory Classification

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.

Submission Summary (Full Text)

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November 19, 2020

Shenzhen Dongjilian Electronics Co., Ltd. % Reanny Wang Manager Shenzhen Reanny Medical Devices Management Consulting Co., Ltd Room 2012#, Gebu commercial building, Hongxing community Songgang Street Shenzhen, Guangdong 518100 China

Re: K201694

Trade/Device Name: Air Compression Therapy Device Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: July 30, 2020 Received: August 21, 2020

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 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

Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K201694

#### Device Name Air Compression Therapy Device

#### Indications for Use (Describe)

The Air Compression Therapy Device are 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 Therapy Device 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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