Leg Massager (Models:RP-ALM070H, RP-ALM071H)

K232965 · Shenzhen Ruiyi Business Technology Co., Ltd. · IRP · Nov 20, 2024 · Physical Medicine

Device Facts

• Record ID: K232965
• Device Name: Leg Massager (Models:RP-ALM070H, RP-ALM071H)
• Applicant: Shenzhen Ruiyi Business Technology Co., Ltd.
• Product Code: IRP · Physical Medicine
• Decision Date: Nov 20, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Leg Massager (Models:RP-ALM070H, RP-ALM071H) is intended for home to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas in people who are in good health.

Device Story

Leg Massager (Models: RP-ALM070H, RP-ALM071H) is a home-use powered inflatable tube massager. System consists of air pump, microprocessor, sensors, and inflatable sleeves connected via hoses. Device performs sequential compression massage from distal (limb end) to proximal (body center) to improve circulation and relieve muscle aches. User selects from multiple massage modes (combining/separate) and adjusts pressure (0-240mmHg) via touch screen interface. Safety features include manual pause/stop functionality. Device operates on 100-240V AC power. Healthcare providers or patients use the device to provide therapeutic compression; output is physical massage, which helps patients relax and temporarily increases local circulation.

Clinical Evidence

Bench testing only. Device performance validated against electrical safety standards (ES 60601-1, IEC 60601-1-2, IEC 60601-1-11) and biocompatibility standards (ISO 10993-5, ISO 10993-10). No clinical data presented.

Technological Characteristics

Powered inflatable tube massager; molded ABS enclosure; nylon/polyurethane laminate sleeves. Sequential compression via compressor and valve system. Pressure range 0-240mmHg; inflation 3-30s; deflation 1-5s. Microprocessor-controlled. Standards: ES 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 10993-5, ISO 10993-10. Non-sterile.

Indications for Use

Indicated for healthy individuals for temporary relief of minor muscle aches/pains and temporary increase in circulation to treated areas.

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.

Predicate Devices

• Air Compression Therapy Device (K193354)
• FLOWpresso (K223729)

Submission Summary (Full Text)

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November 20, 2024

Shenzhen Ruiyi Business Technology Co., Ltd. % Libray Zhang Official Correspondent Shanghai Spica Management Consulting Co., Ltd. 609 Room, No.133 Shengang Avenue, Pudong New District Shanghai. 201306 China

Re: K232965

Trade/Device Name: Leg Massager (Models: RP-ALM070H, RP-ALM071H) Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP. IRT Dated: September 30, 2024 Received: September 30, 2024

Dear Libray Zhang:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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,

# 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) K232965

Device Name

Leg Massager (Models:RP-ALM070H, RP-ALM071H)

Indications for Use (Describe)

Leg Massager (Models:RP-ALM070H, RP-ALM071H) is intended for home to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas in people who are in good health.

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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### K232965

| Type of Submission | Traditional |
|---------------------------|----------------------------------------------------------------------------------------------------------|
| Date Prepared | Jun 27, 2023 |
| Submission Sponsor | |
| Manufacturer Name | Shenzhen Ruiyi Business Technology Co., Ltd. |
| Address | Qianhai Complex A201, Qianwan Road 1, Qianhai<br>Shenzhen-Hong Kong Cooperation Zone,<br>Shenzhen, China |
| Tel | 86-18566621145 |
| Email | [e-mail] |
| Contact Person | derric bai |
| Application Correspondent | |
| Company Name | Shanghai Spica Management Consulting Co., Ltd. |
| Address | 609 Room, No.133 Shengang Avenue, Pudong New<br>District, Shanghai, China |
| Tel | 86-13020102321 |
| Email | [e-mail] |
| Contact Person | Libray Zhang |
| Device Identification | |
| Trade Name | Leg Massager (Models:RP-ALM070H, RP-ALM071H) |
| Regulation Number | 21 CFR 890.5650 |
| Classification Name | Massager, Powered Inflatable Tube |
| Device Classification | Class II |
| Panel | Physical Medicine |
| Product Code | IRP |
| Previous Submissions | None |

#### Indications for Use

Leg Massager (Models:RP-ALM070H, RP-ALM071H) is intended for home to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas in people who are in good health.

#### Device Description

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Leg Massager (Models:RP-ALM070H, RP-ALM071H) is consist of air pressure sensor, air pump, sleeves etc working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses. The compression massage direction is from limb end to body center by inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor.

Leg Massager (Models:RP-ALM070H, RP-ALM071H), in medical market, it has a sequential squeezing from distal to proximal, thus help to improve circulation to the treated areas.

#### Predicate Device Information

| Sponsor | Shenzhen Dongjilian Electronics Co., Ltd. |
|-------------------|-------------------------------------------|
| Trade/Device Name | Air Compression Therapy Device |
| 510(K) number | K193354 |
| Regulation Number | 21 CFR 890.5650 |
| Sponsor | Medella Health Limited |
| Trade/Device Name | FLOWpresso |
| 510(K) number | K223729 |
| Regulation Number | 21 CFR 890.5650 |

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| Table 6A: Summary of Comparison | | |
|---------------------------------|--|--|
| | | |

| | Subject Device | Predicate Device | Differences Discussion |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | Leg Massager (Models:RP-ALM070H,<br>RP-ALM071H) | Air Compression Therapy Device | N/A |
| 510(k)<br>number | K232965 | K193354 | N/A |
| Manufacturer | Shenzhen Ruiyi Business Technology Co.,<br>Ltd. | Shenzhen Dongjilian Electronics<br>Co., Ltd. | N/A |
| Product<br>regulation | 21 CFR 890.5650 | 21 CFR 890.5650 | Same |
| Classification<br>name | Massager, Powered Inflatable Tube | Powered<br>Massager,<br>Inflatable<br>Tube | Same |
| Regulation<br>class | 2 | 2 | Same |
| Product code | IRP | IRP | Same |
| Indications for<br>use | Leg Massager (Models:RP-ALM070H,<br>RP-ALM071H) is intended for home to<br>temporarily relieve minor muscle<br>aches and/or pains, and to temporarily<br>increase circulation to the treated areas in<br>people who are in good health. | The Air Compression Therapy<br>Device is indicated for the<br>temporary relief of minor muscle<br>aches and pains and for<br>temporary increase in circulation<br>to the treated areas in people who<br>are in good health. The Air<br>Compression Therapy Device<br>simulates kneading and stroking<br>of tissues by using an inflatable<br>garment. | Same |
| Rx or OTC | OTC | OTC | Same |
| Pressure range | 0~240mmHg | 0~240mmHg | Same |
| Inflation Time | 3-30s | 3-30s | Same |
| Deflation<br>Time | 1-5s | 1-5s | Same |
| Treatment<br>time | 20 minutes | 20 minutes | Same |
| Standard | ES 60601-1;<br>IEC60601-1-2;<br>ISO 10993-5:<br>ISO 10993-10;<br>IEC 60601-1-11 | ES 60601-1;<br>IEC60601-1-2;<br>ISO 10993-5:<br>ISO 10993-10;<br>IEC 60601-1-11 | Same |
| Mode of<br>compression | Sequential | Sequential/ Peristaltic | Same |
| Power source | 100~240V 50/60Hz | 100~240V 50/60Hz | Same |
| Power<br>consumption | 24W | 12W | Similar |
| Size and | | | |
| appearance of | Thighs: | Leg: | |
| sleeves (leg<br>part) | One size: 11*16*24.9inch+8*33.5inch | One size: 73*26cm | |
| Photo | Image: RP-ALM070H RP-ALM071H | Image | Similar |
| Housing<br>materials | Molded ABS enclosure | Molded ABS enclosure | Same |
| Number of<br>chambers | 3 | 3 | Same |
| Work mode | RP-ALM070H:<br>Six models (3 combine massage modes and<br>3 Separate Massage Modes)<br>C1: Massage full legs.<br>C2: Massage feet and calves.<br>(It can be used individually, and don't need | Mode 1:<br>Starting with the foot chamber<br>and progressing up the thigh<br>chamber, each section<br>compresses and the pressure<br>gradually rises to the | Although the subject device provides 6 kinds of<br>work mode, the Mode F1, F2, F3, M1, M2, M3 are<br>the similar with predicate device (K193354), while<br>the other work modes of subject device just have<br> |
| to connect the air hose of thighs wraps.)<br>C3: Massage feet, calves, thighs by turn. It<br>will be turn off When you press the Button<br>C again.<br>T: Massages thighs<br>C: Massages calves<br>F : Massages feet. It will be turn off when<br>you press the Button S again.<br><br>RP-ALM071H:<br>Five models(3 combine massage modes and<br>2 Separate Massage Modes):<br>Combine 1: Massage feet and calves<br>Combine 2: Massage from calves to feet<br>Combine 3: Massage from feet to calves.<br>Press it again to turn off combine message<br>function.<br>F: Massage feet.<br>C: Massage calves. Press it again to turn off<br>separate massage function. | pre-determined air pressure level,<br>then decompresses and the<br>air pressure drops.<br>Once the thigh section<br>decompresses, the cycle begins<br>again.<br>Mode 1 follows this pressure<br>sequence:<br>Image: Diagram of pressure sequence<br><br>Mode 2:<br>Starting with the foot chamber<br>and progressing up the thigh,<br>each section compresses and the<br>pressure gradually rises to the<br>pre-determined air pressure level,<br>holds the air until the entire<br>garment is compressed.<br>All three sections then<br>decompress simultaneously and<br>the air pressure drops, then cycle<br>begins again.<br>Mode 2 follows this pressure | same under different work modes, so the difference<br>of pressure range would not raise adversely impact<br>on safety and effectiveness. | |
| | | sequence: | |
| | | | |
| | | Mode 3:<br>include two stage, stage 1: it<br>work according to the method of<br>mode 1, after the stage 1 is<br>completed, it go to stage<br>2(working according to the<br>method of mode 2) without<br>interruption time until finish the<br>stage 2, then enter next cycle<br>without interruption.<br>Model1 Mode2<br>The pressure sequence of mode 3<br>combines mode 1 and mode 2 | |
| Safety feature | Button on display allows user to stop or<br>pause therapy session at any time | Button on display allows user to<br>stop or pause therapy session at<br>any time | Same |
| Technology | Compressor and valve system which<br>sequentially inflates inflatable chambers | Compressor and valve system<br>which sequentially inflates<br>inflatable chambers | Same |

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| Operating<br>environment | Temperature: 5°C-40°C,<br>Humidity: 15%-90% | Temperature: 5°C -40°C,<br>Humidity: 5%-90%<br>non-condensing | Same |
|----------------------------------------------|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|---------|
| Transportation<br>and Storage<br>environment | Temperature: - 25°C~70°C<br>Humidity:15%-90% non condensing<br>Atmospheric Pressure:75kPa-106kPa | Temperature: -20°C~55°C;<br>Humidity: 5%-90% non<br>condensing<br>Atmospheric Pressure:75kPa-<br>106kPa | Similar |

# Table 6B: Summary of Comparison

| | Subject Device | Predicate Device | Differences Discussion |
|-------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | Leg Massager (Models:RP-ALM070H,<br>RP-ALM071H) | FLOWpresso | N/A |
| 510(k) number | K232965 | K223729 | N/A |
| Manufacturer | Shenzhen Ruiyi Business Technology Co.,<br>Ltd. | Medella Health Ltd | N/A |
| Product<br>regulation | 21 CFR 890.5650 | 21 CFR…