(88 days)
Not Found
No
The description mentions a microprocessor and sensor controlling the device, but there is no mention of AI, ML, or any learning or adaptive capabilities. The operation appears to be based on pre-programmed sequential inflation/deflation cycles.
Yes
The device is intended to temporarily relieve minor muscle aches and/or pains and to temporarily increase circulation, which are therapeutic claims. It also has a predicate device that is an "Air Compression Therapy Device," further indicating its therapeutic nature.
No
The device description states it is a "Leg Massager" intended to "temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation". It does not mention analyzing or interpreting any physiological data to diagnose a condition.
No
The device description explicitly states it consists of hardware components such as an air pressure sensor, air pump, and sleeves, which work together as a unit.
Based on the provided information, the Leg Massager RF-ALM070 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas." This is a therapeutic and physical function, not a diagnostic one.
- Device Description: The device works by applying air pressure to the legs to provide compression massage. This is a physical mechanism, not a method for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly described as a physical therapy/massage device intended for home use to address muscle discomfort and circulation.
N/A
Intended Use / Indications for Use
Leg Massager RF-ALM070 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.
Product codes
IRP
Device Description
Leg Massager RF-ALM070 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 RF-ALM070, in medical market, it has a sequential squeezing from distal to proximal, thus help to improve circulation to the treated areas.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Legs (explicitly mentioned: foot, calves, thighs)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Clinical: Not Applicable.
Animal: Not Applicable.
The device meets all the applicable technical requirements of : IEC 60601-1-11: 2015 - Medical electrical equipment - Part 1-11: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment IEC 60601-1-2: 2014 - Medical electrical equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 -Medical electrical equipment - Part 1: General requirements for basic safety and essential performance ISO 10993-5: 2009 - Biological Evaluation of Medical Device - Part 5: Tests for in vitro Cytotoxicity ISO 10993-10: 2010 - Biological Evaluation of Medical Devices - Part 10: Tests for irritation and skin sensitization
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 23, 2022
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: K222924
Trade/Device Name: Leg Massager RF-ALM070 Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: May 31, 2022 Received: November 7, 2022
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 (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.
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
1
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
2
Indications for Use
510(k) Number (if known) K222924
Device Name Leg Massager RF-ALM070
Indications for Use (Describe)
Leg Massager RF-ALM070 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.
| 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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3
510(k) Summary
Type of Submission
Date Prepared
Submission Sponsor
Manufacturer Name Address
Tel Email Contact Person
Application Correspondent
Company Name Address
Tel Email Contact Person
Device Identification
Trade Name Regulation Number Classification Name Device Classification Panel Product Code 510(k) Number Previous Submissions Traditional
May 31, 2022
Shenzhen Ruiyi Business Technology Co., Ltd. Qianhai Complex A201, Qianwan Road 1, Qianhai Shenzhen-Hong Kong Cooperation Zone, Shenzhen, China 86-15899775010 Jacky@renpho.com Jacky Li
Shanghai Spica Management Consulting Co., Ltd. 609 Room, No.133 Shengang Avenue, Pudong New District, Shanghai, China 86-13020102321 Libray@spicagloble.com Libray Zhang
Leg Massager RF-ALM070 21 CFR 890.5650 Massager, Powered Inflatable Tube Class II Physical Medicine IRP K222924 None
Indications for Use
Leg Massager RF-ALM070 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
4
Leg Massager RF-ALM070 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 RF-ALM070, in medical market, it has a sequential squeezing from distal to proximal, thus help to improve circulation to the treated areas.
Predicate and Reference 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 |
Performance Testing - Clinical
Not Applicable.
Performance Testing - Animal
Not Applicable.
5
Table 6A: Summary of Comparison
| Subject Device | Predicate Device | Differences Discussion | ||
|---|---|---|---|---|
| Device name | Leg Massager RF-ALM070 | Air Compression Therapy Device | N/A | |
| 510(k) | ||||
| number | K222924 | K193354 | N/A | |
| Manufacturer | Shenzhen Ruiyi Business Technology Co., | |||
| Ltd. | Shenzhen Dongjilian Electronics | |||
| Co., Ltd. | N/A | |||
| Product | ||||
| regulation | 21 CFR 890.5650 | 21 CFR 890.5650 | Same | |
| Classification | ||||
| name | Massager, Powered Inflatable Tube | Massager, Powered Inflatable | ||
| Tube | Same | |||
| Regulation | ||||
| class | 2 | 2 | Same | |
| Product code | IRP | IRP | Same | |
| Indications for | ||||
| use | Leg Massager RF-ALM070 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. | The Air Compression Therapy | |||
| Device is indicated for the | ||||
| temporary relief of minor muscle | ||||
| aches and pains 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. | Same | |||
| Rx or OTC | OTC | OTC | Same | |
| Pressure range | 0~240mmHg | 0~240mmHg | Same | |
| Inflation Time | 3-30s | 3-30s | Same | |
| Deflation | ||||
| Time | 1-5s | 1-5s | Same | |
| Treatment | ||||
| time | 20 minutes | 20 minutes | Same | |
| Standard | ES 60601-1; | |||
| IEC60601-1-2; | ||||
| ISO 10993-5: | ||||
| ISO 10993-10; | ||||
| IEC 60601-1-11 | ES 60601-1; | |||
| IEC60601-1-2; | ||||
| ISO 10993-5: | ||||
| ISO 10993-10; | ||||
| IEC 60601-1-11 | Same | |||
| Mode of | ||||
| compression | Sequential | Sequential/ Peristaltic | Same | |
| Power source | 100~240V 50/60Hz | 100~240V 50/60Hz | Same | |
| Power | ||||
| consumption | 7.2W | 12W | Similar | |
| Size and | ||||
| appearance of | ||||
| sleeves (leg | ||||
| part) | Thighs: | |||
| One size: 20.3*27.1cm | Leg: | |||
| One size: 73*26cm | ||||
| Photo | Similar | |||
| Image: Calves | ||||
| Calves: | ||||
| One size: 68.6*20.1cm |
Image: Calves | | Molded ABS enclosure | Molded ABS enclosure | Same |
| Number of
chambers | 3 | 3 | Same | |
| Work mode | Six models (3 Combine massage modes and
3 Separate Massage Modes)
F1: Massage feet calves and thighs. Starting
with the foot chamber and progressing up
the thigh.
F1 follows this pressure sequence: | Mode 1:
Starting with the foot chamber
and progressing up the thigh
chamber, each section
compresses and the pressure
gradually rises to the
pre-determined air pressure level,
then decompresses and the
air pressure drops.
Once the thigh section
decompresses, the cycle begins | Although the subject device provides 6 kinds of
work mode, the Mode F1, F2, F3, M1, M2, M3 are
the similar with predicate device (K193354), while
the other work modes of subject device just have
difference about inflatable order of the different
chambers. The treatment pressure range are the
same under different work modes, so the difference
of pressure range would not raise adversely impact
on safety and effectiveness. | |
6
7
8
| F1
Image: [leg sequence 1] | again.
Mode 1 follows this pressure
sequence:
Image: [leg sequence 2] |
|----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Mode 2:
Starting with the foot chamber
and progressing up the thigh,
each section compresses and the
pressure gradually rises to the
pre-determined air pressure level,
holds the air until the entire
garment is compressed.
All three sections then
decompress simultaneously and
the air pressure drops, then cycle
begins again.
Mode 2 follows this pressure
sequence: |
| F2: Massage from thighs to feet, and then
enter cycle.
F2 follows this pressure sequence:
Image: [leg sequence 3] | |
9
Image /page/9/Figure/0 description: The image shows a diagram labeled F2, illustrating a sequence of six leg positions or exercises, each paired with a number from 1 to 6. Each pair of positions is marked with "Six Cycles" and a circular arrow, suggesting a repetition of the sequence. Some of the leg positions have a blue overlay, possibly indicating a specific area of focus or pressure during the exercise.
F3: Massage from feets to thighs by turn, and then from thighs to feet. F3 follows this pressure sequence:
Image /page/9/Figure/2 description: The image shows a diagram of a leg with a compression device on it. The diagram shows four different stages of the compression device being applied to the leg. The stages are numbered 1 through 4, and the device is shown being applied to the leg in a sequential manner. The image is labeled F3.
M1: Massage feet, the pressure gradually rises to the pre-determined air pressure level, then decompresses and the air pressure drops. M1 follows this pressure sequence:
Image /page/9/Picture/4 description: The image shows a diagram of peristalsis. The diagram shows three stages of peristalsis, with the top stage showing the beginning of the process, the middle stage showing the middle of the process, and the bottom stage showing the end of the process. The diagram shows how the muscles in the digestive tract contract and relax to move food through the digestive system. The arrows in the diagram show the direction of movement of the food.
Mode 3: include two stage, stage 1: it work according to the method of mode 1, after the stage 1 is completed, it go to stage 2(working according to the method of mode 2) without interruption time until finish the stage 2, then enter next cycle without interruption.
Image /page/9/Picture/6 description: The image shows two words, "Model1" and "Mode2", with a double-headed arrow between them. The arrow points from "Model1" to "Mode2" and from "Mode2" to "Model1", indicating a bidirectional relationship or transformation between the two models. The text and arrow are simple and clear, suggesting a straightforward connection or interchange between the two concepts.
The pressure sequence of mode 3 combines mode 1 and mode 2
10
Image /page/10/Figure/0 description: The image shows a table with three columns. The first column shows the massage modes M1, M2, and M3. M2 massages the calves, and the pressure gradually rises to the pre-determined air pressure level, then decompresses and the air pressure drops. M3 massages the thighs, and the pressure gradually rises to the pre-determined air pressure level, then decompresses and the air pressure drops. The bottom row of the table shows the safety feature, which is a button on the display that allows the user to stop or start the massage.
11
| | pause therapy session at any time | stop or pause therapy session at
any time | |
|----------------------------------------------|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|---------|
| Technology | Compressor and valve system which
sequentially inflates inflatable chambers | Compressor and valve system which sequentially inflates
inflatable chambers | Same |
| Operating
environment | Temperature: 5°C- 40°C,
Humidity: 15%- 90% | Temperature: 5°C - 40°C,
Humidity:5%- 90%
non-condensing | Same |
| Transportation
and Storage
environment | Temperature: - 20°C55°C55°C;
Humidity:15%-90% non condensing
Atmospheric Pressure:75kPa-106kPa | Temperature: - 20°C
Humidity:5%-90% non
condensing
Atmospheric Pressure:75kPa-
106kPa | Similar |
12
Summary of the technological characteristics of the device
The device meets all the applicable technical requirements of : IEC 60601-1-11: 2015 - Medical electrical equipment - Part 1-11: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment IEC 60601-1-2: 2014 - Medical electrical equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 -Medical electrical equipment - Part 1: General requirements for basic safety and essential performance ISO 10993-5: 2009 - Biological Evaluation of Medical Device - Part 5: Tests for in vitro Cytotoxicity ISO 10993-10: 2010 - Biological Evaluation of Medical Devices - Part 10: Tests for irritation and skin sensitization
Conclusion
Based on the indications for use, technological characteristics, and non-clinical performance data, "Leg Massager RF-ALM070 (K222924)" is as safe, as effective, and performs as well as the legally marketed predicate devices, "Air Compression Therapy Device (K193354)". Therefore, the subject device is substantially equivalent to the predicate device.