(426 days)
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.
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.
Here's an analysis of the provided FDA 510(k) summary, specifically addressing acceptance criteria and study information related to the device.
Key Observation: The document describes a traditional medical device (Leg Massager) and an application for substantial equivalence based on a comparison to predicate devices, not an AI/ML-powered device. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable to this type of submission. This document focuses on demonstrating substantial equivalence through technical specifications, indications for use, and adherence to recognized standards, rather than clinical performance based on AI/ML algorithms.
Acceptance Criteria and Device Performance (Not Applicable - Traditional Device)
Since this is a traditional medical device submission for a Leg Massager (Models: RP-ALM070H, RP-ALM071H) and not an AI/ML-powered device, the concept of "acceptance criteria" and "reported device performance" in the context of an algorithm's diagnostic accuracy is not directly applicable.
Instead, the submission demonstrates substantial equivalence by showing that the device meets the same indications for use and has similar technological characteristics to existing legally marketed predicate devices, and that it complies with recognized safety and performance standards.
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Characteristic | Predicate Device (K193354) Performance / Standard | Predicate Device (K223729) Performance / Standard | Subject Device (K232965) Performance | Acceptance (Substantially Equivalent) |
|---|---|---|---|---|
| Indications for Use | Temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas in people who are in good health. | Treat post traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy are indicated. Relieve pain by combining heat therapy with air compression on the affected area. | Temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas in people who are in good health. | Same / Similar (Subject device's intended use aligns with both predicates, with K223729 having broader original indications but fundamental pain/circulation relief remains similar). |
| Regulation Number | 21 CFR 890.5650 | 21 CFR 890.5650 | 21 CFR 890.5650 | Same |
| Classification Name | Massager, Powered Inflatable Tube | Massager, Powered Inflatable Tube | Massager, Powered Inflatable Tube | Same |
| Regulation Class | Class II | Class II | Class II | Same |
| Product Code | IRP | IRP, IRT | IRP, IRT | Same |
| Rx or OTC | OTC | (Not explicitly stated for K223729, but implies professional setting.) | OTC | Same (with K193354) |
| Pressure Range | 0~240mmHg | 5-130mm/Hg | 0~240mmHg | Similar (Subject device aligns with K193354, K223729 has a narrower range but "pressure range is dependent on patient comfort levels and are adjusted in real-time.") |
| Inflation Time | 3-30s | N/A (implied by sequential/peristaltic) | 3-30s | Same (with K193354) |
| Deflation Time | 1-5s | N/A (implied by sequential/peristaltic) | 1-5s | Same (with K193354) |
| Treatment Time | 20 minutes | 01-40 minutes | 20 minutes | Similar (Subject device falls within predicate's range) |
| Max Heat Therapy | N/A (No heat mentioned) | Default: 86°F - 104°F | Not exceeding 45°C (113°F) | Similar (Subject device max temp slightly higher but noted to pass IEC testing; heat program optional) |
| Mode of Compression | Sequential | Sequential/Peristaltic | Sequential | Same |
| Power Consumption | 12W | N/A | 24W | Similar |
| Number of Chambers | 3 | N/A (implied multiple zones) | 3 | Same (with K193354) |
| Electrical Safety Standards | ES60601-1; IEC60601-1-2; ISO 10993-5;-10; IEC60601-1-11 | ANSI/AAMI ES60601-1; IEC 60601-1; EN60601-1 | ES60601-1; IEC60601-1-2; IEC60601-1-11 | Same / Similar (Compliance with recognized overarching standards) |
| Biocompatibility | ISO 10993-5, -10 | ISO 10993-5, -10 | ISO 10993-5, -10 | Same |
Summary of Study:
The study presented in this 510(k) submission is a comparison study to demonstrate substantial equivalence to legally marketed predicate devices. It is not a clinical trial evaluating the device's efficacy or an AI/ML performance study. The "study" involves a detailed comparison of the subject device's (Leg Massager Models: RP-ALM070H, RP-ALM071H) indications for use, technological characteristics, safety features, performance specifications, and adherence to recognized electrical and biocompatibility standards against two predicate devices:
- Shenzhen Dongjilian Electronics Co., Ltd. - Air Compression Therapy Device (K193354)
- Medella Health Limited - FLOWpresso (K223729)
The core methodology is a side-by-side comparison table (Table 6A and 6B) detailing each characteristic and providing a "Differences Discussion" to justify why any minor differences do not raise new questions of safety or effectiveness.
Detailed breakdown of requested information:
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 is not an AI/ML performance study with a test set of data. The submission relies on a comparison of technical specifications and adherence to standards.
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. Ground truth establishment by experts is relevant for diagnostic accuracy studies, typically involving AI/ML. This submission is for a physical medical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or expert adjudication is involved in this type of submission.
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 is a physical device, not an AI/ML-powered diagnostic aid involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. There is no algorithm for standalone performance in this device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" here is the established safety and effectiveness of the predicate devices based on their FDA clearance and compliance with recognized consensus standards (e.g., IEC 60601-1, ISO 10993).
8. The sample size for the training set
- Not applicable. This device does not use an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As no training set is used, no ground truth for it was established.
Conclusion from the document:
The FDA's decision to clear the device (K232965) indicates that based on the provided comparison and adherence to standards, the Leg Massager (Models: RP-ALM070H, RP-ALM071H) is considered substantially equivalent to the predicate devices and is deemed as safe, effective, and performs as well. The acceptance is based on alignment of functional characteristics, intended use, and compliance with general safety and performance standards.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
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 (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) 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, QianhaiShenzhen-Hong Kong Cooperation Zone,Shenzhen, China |
| Tel | 86-18566621145 |
| derric@renpho.com | |
| Contact Person | derric bai |
| Application Correspondent | |
| Company Name | Shanghai Spica Management Consulting Co., Ltd. |
| Address | 609 Room, No.133 Shengang Avenue, Pudong NewDistrict, Shanghai, China |
| Tel | 86-13020102321 |
| Libray@spicagloble.com | |
| 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,RP-ALM071H) | Air Compression Therapy Device | N/A |
| 510(k)number | K232965 | 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 | PoweredMassager,InflatableTube | Same |
| Regulationclass | 2 | 2 | Same |
| Product code | IRP | IRP | Same |
| Indications foruse | Leg Massager (Models:RP-ALM070H,RP-ALM071H) is intended for home totemporarily 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 | 24W | 12W | Similar |
| Size and | |||
| appearance of | Thighs: | Leg: | |
| sleeves (legpart) | One size: 111624.9inch+8*33.5inch | One size: 73*26cm | |
| Photo | Image: RP-ALM070H RP-ALM071H | Image | Similar |
| Housingmaterials | Molded ABS enclosure | Molded ABS enclosure | Same |
| Number ofchambers | 3 | 3 | Same |
| Work mode | RP-ALM070H:Six models (3 combine massage modes and3 Separate Massage Modes)C1: Massage full legs.C2: Massage feet and calves.(It can be used individually, and don't need | Mode 1:Starting with the foot chamberand progressing up the thighchamber, each sectioncompresses and the pressuregradually rises to the | 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 have |
| to connect the air hose of thighs wraps.)C3: Massage feet, calves, thighs by turn. Itwill be turn off When you press the ButtonC again.T: Massages thighsC: Massages calvesF : Massages feet. It will be turn off whenyou press the Button S again.RP-ALM071H:Five models(3 combine massage modes and2 Separate Massage Modes):Combine 1: Massage feet and calvesCombine 2: Massage from calves to feetCombine 3: Massage from feet to calves.Press it again to turn off combine messagefunction.F: Massage feet.C: Massage calves. Press it again to turn offseparate massage function. | pre-determined air pressure level,then decompresses and theair pressure drops.Once the thigh sectiondecompresses, the cycle beginsagain.Mode 1 follows this pressuresequence:Image: Diagram of pressure sequenceMode 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 pressure | same under different work modes, so the differenceof pressure range would not raise adversely impacton safety and effectiveness. | |
| sequence: | |||
| Mode 3:include two stage, stage 1: itwork according to the method ofmode 1, after the stage 1 iscompleted, it go to stage2(working according to themethod of mode 2) withoutinterruption time until finish thestage 2, then enter next cyclewithout interruption.Model1 Mode2The pressure sequence of mode 3combines mode 1 and mode 2 | |||
| Safety feature | Button on display allows user to stop orpause therapy session at any time | Button on display allows user tostop or pause therapy session atany time | Same |
| Technology | Compressor and valve system whichsequentially inflates inflatable chambers | Compressor and valve systemwhich sequentially inflatesinflatable chambers | Same |
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| Operatingenvironment | Temperature: 5°C-40°C,Humidity: 15%-90% | Temperature: 5°C -40°C,Humidity: 5%-90%non-condensing | Same |
|---|---|---|---|
| Transportationand Storageenvironment | Temperature: - 25°C~70°CHumidity:15%-90% non condensingAtmospheric Pressure:75kPa-106kPa | Temperature: -20°C~55°C;Humidity: 5%-90% noncondensingAtmospheric Pressure:75kPa-106kPa | Similar |
Table 6B: Summary of Comparison
| Subject Device | Predicate Device | Differences Discussion | |
|---|---|---|---|
| Device name | Leg Massager (Models:RP-ALM070H,RP-ALM071H) | FLOWpresso | N/A |
| 510(k) number | K232965 | K223729 | N/A |
| Manufacturer | Shenzhen Ruiyi Business Technology Co.,Ltd. | Medella Health Ltd | N/A |
| Productregulation | 21 CFR 890.5650 | 21 CFR 890.5650 | Same |
| Classificationname | Massager, Powered Inflatable Tube | Massager, Powered Inflatable Tube | Same |
| Regulation class | 2 | 2 | Same |
| Product code | IRP, IRT | IRP, IRT | Same |
| Indicationsfor Use | Leg Massager (Models:RP-ALM070H,RP-ALM071H) is intended for home totemporarily relieve minor muscle aches | The Flowpresso Device combines heatand compression therapy.Flowpresso is intended to treat post | Similar, although the predicate device isintended to treat post traumatic andpost-surgical medical and/or surgical |
| and/or pains, and to temporarily increasecirculation to the treated areas in peoplewho are in good health. | traumatic and post-surgical medicaland/or surgical conditions for whichlocalized thermal therapy are indicated.Flowpresso is intended to be used by, oron the order of, licensed health careprofessionals based in rehabilitationfacilities, outpatient clinics and athletictraining settings. | conditions for which localized thermaltherapy are indicated, the subject deviceis ,the working principles and expectedoutcomes of the two are consistent. All ofthem relieve pain by combining heattherapy with air compression on theaffected area (subject device only coversthe thighs, calves, and feet, predictivedevice also includes the back/hip), allowingpatients to relax. | |
| Number ofpatients thatcan be treatedat one time | One | One | Same |
| TreatmentTime | 20 minutes | 01-40 minutes | Different, Although the “TreatmentTime” of the subject device is differentthan the predicate devices, the treatmenttime of the subject device is included in thepredicate device. |
| Heat Therapy | Not exceeding 45°C | Default: 86°F - 104°F | Similar, the maximum temperature of thesubject device is slightly higher than that ofthe predicate device. The heating programof the subject device can be selected to beturned on or not, and all have passed IECtesting. Small differences do not affectsafety and effectiveness. |
| CompressionPressureLevels | 0〜240mmHg | 5-130mm/Hg | Different, pressure range is dependent onpatient comfort levels and are adjusted inreal-time. |
| Static orIntermittentPressure | Both | Both | Same |
| Power Down | Available | Available | Same |
| HeatingMechanism | Thermotherapy | Thermotherapy | Same |
| User Interface | Touch Screen | Touch Screen | Same |
| Line voltage | 100~240V | 110-220V | Similar |
| LineFrequency | 50/60Hz | 50/60 Hz | Same |
| ElectricalSafetyStandards | ES 60601-1;IEC60601-1-2;IEC 60601-1-11 | ANSI/AAMI ES60601-1:2005 + A1:2012IEC 60601-1:2005 + A1:2012EN60601-1:2006 +A1:2013 | Similar |
| OperatingTemperature | 5°C- 40°C | 60°F - 80°F (16°C - 27°C) | Different, Although the "OperatingTemperature"of the subject device isdifferent than the predicate devices, theycomply with ANSI/AAMI ES60601-1, sothe difference does not affect the safety andeffectiveness. |
| StorageTemperature | - 25°C~70°C | 33°F - 122°F (1°C - 50°C) | Different, Although the "StorageTemperature"of the subject device isdifferent than the predicate devices, theycomply with ANSI/AAMI ES60601-1, so |
| OperatingHumidity | 15%-90% | Below 60% Noncondensing | the difference does not affect the safety andeffectiveness.Different, Although the "OperatingHumidity" of the subject device is differentthan the predicate devices, they complywith ANSI/AAMI ES60601-1, so thedifference does not affect the safety andeffectiveness. |
| StorageHumidity | 15%-90% | Below 60% Noncondensing | Different, Although the "StorageHumidity" of the subject device is differentthan the predicate devices, they complywith ANSI/AAMI ES60601-1, so thedifference does not affect the safety andeffectiveness. |
| OperatingAtmosphericPressure andAltitude | 75kPa-106kPa | 700 hPa – 1060 hPa(corresponds to a max. elevationof 9,842 ft. 6 in (3000m)) | Similar |
| Types ofGarments | Sleeves for thighs, calves, and feet | Various anatomicalthermal/compression garmentsfor: Back/Hip, arm, leg, feet | Different, the type of garments of thepredicate device exceeds that of the subjectdevice, which does not include the back/ippart. So the risk of subject device is smallerthan that of predicate device. |
| PatientContactingMaterial | All encompassed with a Nylon with aPolyurethane laminate material. | Needle cotton, non-conductiveand non-woven lining. Allencompassed with a PVCmaterial. | Different, Although the material of thesubject device is different than the predicatedevices, they comply with ISO10993-5 andISO10993-10, so the difference does not |
| affect the safety and effectiveness. | |||
| Multi-PatientUse and SinglePatient UseWraps | Multi-Patient Use | Multi-Patient Use | Same |
| Biocompatibility | Cytotoxicity testing per ISO10993-5Sensitization testing per ISO10993-10Irritation testing perISO 10993-10 | Cytotoxicity testing per ISO10993-5Sensitization testing per ISO10993-10Irritation testing perISO 10993-10 | Same |
| Sterile/NonSterile | Non-sterile only | Non-sterile only | Same |
| CleaningDisinfectionValidation ofLabeling | Yes- for Multi-Patient usereusable wraps | Yes- for Multi-Patient usereusable wraps | Same |
| Human Factorstesting toconfirmintended usershave foundinstructions forcleaning anddisinfectioneasy to use | Yes- for Multi-Patient usereusable wraps | Yes- for Multi-Patient usereusable wraps | Same |
| Expected Life of | Based on frequency of use and | Based on frequency of use and | Same |
| Garments | continued functionalperformance | continued functionalperformance | |
| Validation ofrepeatedcleaning anddisinfection forreusablegarments | Yes- for Multi-Patient usereusable wraps | Yes- for Multi-Patient usereusable wraps | Same |
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Summarv 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 IEC TS 60601-4-2: Medical electrical equipment - Part 4-2: Guidance and interpretation -Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems 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 (Models:RP-ALM070H, RP-ALM071H)" is as safe, as effective, and performs as well as the legally marketed predicate devices. 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).