(88 days)
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.
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.
This FDA 510(k) summary for the Leg Massager RF-ALM070 (K222924) does not contain information about acceptance criteria and a study proving the device meets those criteria in the way typically expected for an AI/ML medical device.
The document is a substantial equivalence determination for a physical massager, not an AI/ML diagnostic or therapeutic device. Therefore, the questions related to AI/ML device performance (e.g., sample size for test set, expert ground truth, MRMC studies, standalone performance) are not applicable to the content provided.
Instead, the document details a comparison of the Leg Massager RF-ALM070 to a predicate device (Air Compression Therapy Device, K193354) to demonstrate substantial equivalence based on technological characteristics and non-clinical performance data.
Here's an analysis based on the available information, addressing the spirit of your request where possible given the device type:
Description of Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria
For the Leg Massager RF-ALM070, the "acceptance criteria" are implicitly defined by its substantial equivalence to the predicate device (Air Compression Therapy Device, K193354). The study proving the device meets these criteria is the comparison of its specifications and adherence to recognized standards with those of the predicate device.
The primary goal of this 510(k) submission is to demonstrate that the new device is as safe and effective as a legally marketed predicate device. This is achieved by showing that the new device has the same intended use, similar technological characteristics, and meets relevant performance standards.
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence comparison for a non-AI/ML device, the "acceptance criteria" are essentially the specifications and performance of the predicate device. The "reported device performance" is how the subject device matches or is similar to these.
Table: Comparison of Subject Device (Leg Massager RF-ALM070) to Predicate Device (Air Compression Therapy Device)
| Aspect | Predicate Device (K193354) Specification (Implicit Acceptance Criteria) | Subject Device (K222924) Reported Performance | Comparison / Rationale for Equivalence |
|---|---|---|---|
| Indications for Use | Temporary relief of minor muscle aches and pains; temporary increase in circulation to treated areas in people who are in good health. | Same | 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 |
| Mode of Compression | Sequential / Peristaltic | Sequential | The subject device offers 6 work modes, which are described as similar to the predicate device's modes, with differences primarily in the inflatable order of chambers. The pressure range remains the same across modes, not raising adverse impact on safety and effectiveness. |
| Power Consumption | 12W | 7.2W | Similar. (Difference is minor and likely acceptable as lower power consumption is generally not a safety/effectiveness concern for this type of device, provided function is maintained). |
| Number of Chambers | 3 | 3 | Same |
| Safety Feature | Button to stop or pause therapy session at any time | Button to stop or pause therapy session at any time | Same |
| Standards Adhered To | ES 60601-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10, IEC 60601-1-11 | ES 60601-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10, IEC 60601-1-11 | The subject device meets all applicable technical requirements of these standards, demonstrating electrical safety, EMC compatibility, and biocompatibility, mirroring the predicate device's compliance. |
| Performance Testing | Not applicable (Clinical/Animal) | Not applicable (Clinical/Animal) | Both predicate and subject devices did not require clinical or animal performance testing for their 510(k) clearances, indicating that non-clinical data (such as engineering and comparative testing) was sufficient to demonstrate safety and effectiveness for this device type. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document explicitly states "Performance Testing - Clinical: Not Applicable" and "Performance Testing - Animal: Not Applicable." The demonstration of substantial equivalence relies on comparison of design specifications, technological characteristics, and adherence to recognized electrical and biocompatibility standards, rather than clinical or animal test data. No "test set" of patient data was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This pertains to AI/ML device validation with expert-annotated data, which is not relevant for this physical massager.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This pertains to AI/ML device validation with expert-annotated data, which is not relevant for this physical massager.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This pertains to AI/ML device validation with human-in-the-loop studies, which is not relevant for this physical massager.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This pertains to AI/ML device validation, which is not relevant for this physical massager.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this type of device, ground truth as understood in AI/ML validation (e.g., disease presence/absence) is not established in the same manner. The "ground truth" for the non-clinical performance aspects would be objective measurements (e.g., pressure output, timing, electrical safety parameters) compared against specified engineering requirements and recognized standards.
8. The sample size for the training set
Not applicable. There is no AI/ML component described which would require a training set.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML component described which would require a training set or its associated ground truth establishment.
In summary, the provided FDA document is for a non-AI/ML medical device. The "study" for demonstrating acceptance criteria is a comprehensive comparison of the device's technical specifications and compliance with safety standards against those of a legally marketed predicate device. The detailed questions about AI/ML performance testing are not applicable in this context.
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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
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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
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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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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
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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.
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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 ElectronicsCo., Ltd. | N/A | |
| Productregulation | 21 CFR 890.5650 | 21 CFR 890.5650 | Same | |
| Classificationname | Massager, Powered Inflatable Tube | Massager, Powered InflatableTube | Same | |
| Regulationclass | 2 | 2 | Same | |
| Product code | IRP | IRP | Same | |
| Indications foruse | Leg Massager RF-ALM070 is intended forhome to temporarily relieve minor muscleaches and/or pains, and to temporarilyincrease circulation to the treated areas inpeople who are in good health. | The Air Compression TherapyDevice is indicated for thetemporary relief of minor muscleaches and pains and fortemporary increase in circulationto the treated areas in people whoare in good health. The AirCompression Therapy Devicesimulates kneading and strokingof tissues by using an inflatablegarment. | Same | |
| Rx or OTC | OTC | OTC | Same | |
| Pressure range | 0~240mmHg | 0~240mmHg | Same | |
| Inflation Time | 3-30s | 3-30s | Same | |
| DeflationTime | 1-5s | 1-5s | Same | |
| Treatmenttime | 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 ofcompression | Sequential | Sequential/ Peristaltic | Same | |
| Power source | 100~240V 50/60Hz | 100~240V 50/60Hz | Same | |
| Powerconsumption | 7.2W | 12W | Similar | |
| Size andappearance ofsleeves (legpart) | Thighs:One size: 20.3*27.1cm | Leg:One size: 73*26cm | ||
| Photo | Similar | |||
| Image: CalvesCalves:One size: 68.6*20.1cmImage: Calves | Molded ABS enclosure | Molded ABS enclosure | Same | |
| Number ofchambers | 3 | 3 | Same | |
| Work mode | Six models (3 Combine massage modes and3 Separate Massage Modes)F1: Massage feet calves and thighs. Startingwith the foot chamber and progressing upthe thigh.F1 follows this pressure sequence: | Mode 1:Starting with the foot chamberand progressing up the thighchamber, each sectioncompresses and the pressuregradually rises to thepre-determined air pressure level,then decompresses and theair pressure drops.Once the thigh sectiondecompresses, the cycle begins | Although the subject device provides 6 kinds ofwork mode, the Mode F1, F2, F3, M1, M2, M3 arethe similar with predicate device (K193354), whilethe other work modes of subject device just havedifference about inflatable order of the differentchambers. The treatment pressure range are thesame under different work modes, so the differenceof pressure range would not raise adversely impacton safety and effectiveness. |
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| F1Image: [leg sequence 1] | again.Mode 1 follows this pressuresequence:Image: [leg sequence 2] |
|---|---|
| Mode 2:Starting with the foot chamberand progressing up the thigh,each section compresses and thepressure gradually rises to thepre-determined air pressure level,holds the air until the entiregarment is compressed.All three sections thendecompress simultaneously andthe air pressure drops, then cyclebegins again.Mode 2 follows this pressuresequence: | |
| F2: Massage from thighs to feet, and thenenter cycle.F2 follows this pressure sequence:Image: [leg sequence 3] |
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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
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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.
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| pause therapy session at any time | stop or pause therapy session atany time | ||
|---|---|---|---|
| Technology | Compressor and valve system whichsequentially inflates inflatable chambers | Compressor and valve system which sequentially inflatesinflatable chambers | Same |
| Operatingenvironment | Temperature: 5°C- 40°C,Humidity: 15%- 90% | Temperature: 5°C - 40°C,Humidity:5%- 90%non-condensing | Same |
| Transportationand Storageenvironment | Temperature: - 20°C~55°CHumidity:15%-90% non condensingAtmospheric Pressure:75kPa-106kPa | Temperature: - 20°C~55°C;Humidity:5%-90% noncondensingAtmospheric Pressure:75kPa-106kPa | Similar |
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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.
§ 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).