(139 days)
The Air Compression Massager is an air pressure massager intended to temporarily relieve minor muscle aches and or pains, and to temporarily increase circulation to the treated areas.
The Air Compression Massager is a medical device that utilizes the principle of air pressure to provide massage to the legs by inflating and deflating. It aims to provide temporary relief for minor muscle aches or pains while temporarily increasing circulation in treated areas. It consists of a sleeve, a main unit and a battery. It mimics manual kneading and stroking of tissues through the use of an inflatable pressure sleeve. The sleeve features 5 chambers designed for different body areas including the foot/ankle, calf, knee, lower quad and upper quad. Controlled by the main unit, it can be sequentially inflated and deflated to apply circulating pressure on targeted body areas. The main component materials of the sleeve are Nylon cloth, thermoplastic polyurethane (TPU). It is available in four sizes: XL (Extra large), L (large), M (medium) and S (small). We offer four models of main unit, ACM-A1, ACM-A2, ACM-A3 and ACM-A4.The main unit is made of polycarbonate (PC) and acrylonitrile-butadiene-styrene (ABS). It is the integrated control center that is responsible for starting and stopping treatments, regulating pressure, and mode selection to ensure a precise and safe treatment process. The user interface is a series of buttons showing battery level, pressure level, mode adjustment. The user interface provides for: Starting and stopping the massage treatment; Adjusting intensity (pressure) of the treatment; Select the treatment mode. The air compression massager is charged using® an external compliant power supply as well as powered by an internal IEC 62133-2 compliant lithium-ion battery. All four models of the Air Compression Massager are available with 800mAh, 1000mAh and 2000mAh batteries. In addition, the devices have Bluetooth capability that allows the use of a Mobile app to control the device. The Bluetooth app allows the user to use a compatible Android or iOS phone to select and set device parameters listed above for convenience.
This document is a 510(k) summary for the Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4). It does not contain information about a study that proves the device meets specific acceptance criteria in the context of clinical performance or effectiveness for the stated indications.
The document focuses on demonstrating substantial equivalence to a predicate device (Normatec Elite, K240122) based on technological characteristics, intended use, and conformance to recognized safety and performance standards. It does not present a clinical study with an acceptance criteria table, sample sizes for test sets, expert-established ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.
Here's a breakdown of the information that is available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of acceptance criteria for clinical performance or a direct comparison of the device's performance against such criteria. Instead, it lists standards the device has met, which serve as performance requirements in a different context (safety, electromagnetic compatibility, biocompatibility).
| Characteristic / Test | Acceptance Criteria (Implied by standard conformance, not explicitly stated as performance criteria) | Reported Device Performance |
|---|---|---|
| Safety and Electrical Performance: | Conformance to specified standard | Met IEC 60601-1:2005+AMD1:2012+AMD2:2020 |
| Electromagnetic Compatibility: | Conformance to specified standard | Met IEC 60601-1-2 Edition 3: 2007-03 |
| Home Healthcare Environment: | Conformance to specified standard | Met IEC 60601-1-11:2015+AMD1:2020 |
| Electromagnetic Immunity: | Conformance to specified standard | Met IEC/TS 60601-4-2:2024 |
| Wireless Coexistence: | Conformance to specified standard | Met IEEE ANSI/USEMCSC C63.27 |
| Biocompatibility - In Vitro Cytotoxicity: | Conformance to specified standard | Met ISO10993-5:2009 |
| Biocompatibility - Skin Sensitization: | Conformance to specified standard | Met ISO 10993-10:2021 |
| Biocompatibility - Irritation: | Conformance to specified standard | Met ISO 10993-23:2021 |
| Pressure accuracy testing: | (Not explicitly stated in the provided text) | Tested and met requirements (implied) |
| Seam strength testing to ensure cuffs do not burst if maximum pressure is exceeded: | (Not explicitly stated in the provided text) | Tested and met requirements (implied) |
| Failure mode verification and validation testing to ensure mitigation of overpressurization risk if there is software failure: | (Not explicitly stated in the provided text) | Tested and met requirements (implied) |
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. The document does not describe a clinical test set or study of this nature. The testing mentioned is bench testing and conformance 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. No clinical test set requiring expert ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set is described.
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 device is an air compression massager, not an AI-powered diagnostic tool, so an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No clinical study with ground truth is described. The "ground truth" for the engineering and safety tests would be the established specifications and regulatory standards.
8. The sample size for the training set
Not applicable. The device is not an AI/Machine Learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
Summary of what is provided:
The document states that the Air Compression Massager was tested for various performance characteristics and met the requirements of several international standards related to medical electrical equipment safety, electromagnetic compatibility, home healthcare environments, wireless coexistence, and biocompatibility. Additionally, specific bench testing for pressure accuracy, seam strength, and failure mode verification for over-pressurization risk due to software failure was conducted. These tests are presented as evidence that the device is as safe and effective as the predicate device and thus substantially equivalent. However, these are primarily engineering and safety tests, not clinical performance studies to assess the "temporary relief of minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas" against specific clinical acceptance criteria.
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October 8, 2024
Sichuan QianIi-beoka Medical TechnoIogy Inc. % Ariel Xiang Consultant Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave. Shanghai, 200122 China
Re: K241446
Trade/Device Name: Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4) Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: September 9, 2024 Received: September 9, 2024
Dear Ariel Xiang:
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.
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).
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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 OS 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.
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-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).
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Sincerely,
Tushar Bansal -S
for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation 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) K241446
Device Name
Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4)
Indications for Use (Describe)
The Air Compression Massager is an air pressure massager intended to temporarily relieve minor muscle aches and or pains, and to temporarily increase circulation to the treated areas.
| 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
Document Prepared Date: October 4, 2024
A. Applicant:
Sponsor: Sichuan Qianli-beoka Medical Technology Inc. Address: Longtan Industrial Park 2nd Sec, East 3rd Ring Road, Chenghua District, Chengdu, Sichuan, China 610052 Contact Person: Wei Zeng Tel: +86-028-84215340 E-mail: cdqldz@163.com
Submission Correspondent: Primary contact: Mr. Ariel Xiang Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Central Ave., Shanghai 200122, China Tel: +86-21- 58817802 Email: shouqiu.xiang@sungoglobal.com Secondary contact: Mr. Raymond Luo 14th Floor, Dongfang Building, 1500# Central Ave., Shanghai 200122, China Tel: +86-21- 68828050 Email: zxfda@sungoglobal.com
B. Subject Device
Device Name: Air Compression Massager Model(s): ACM-A1, ACM-A2, ACM-A3, ACM-A4 Classification Name: Powered inflatable tube massager Review Panel: Physical Medicine Product Code: IRP Regulation Number: 21 CFR 890.5650 Regulation Class: II
ﻥ Predicate Device
K240122 Normatec Elite NormaTec Industries, LP
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D. Device Description
The Air Compression Massager is a medical device that utilizes the principle of air pressure to provide massage to the legs by inflating and deflating. It aims to provide temporary relief for minor muscle aches or pains while temporarily increasing circulation in treated areas. It consists of a sleeve, a main unit and a battery.
It mimics manual kneading and stroking of tissues through the use of an inflatable pressure sleeve. The sleeve features 5 chambers designed for different body areas including the foot/ankle, calf, knee, lower quad and upper quad. Controlled by the main unit, it can be sequentially inflated and deflated to apply circulating pressure on targeted body areas. The main component materials of the sleeve are Nylon cloth, thermoplastic polyurethane (TPU). It is available in four sizes: XL (Extra large), L (large), M (medium) and S (small).
We offer four models of main unit, ACM-A1, ACM-A2, ACM-A3 and ACM-A4.The main unit is made of polycarbonate (PC) and acrylonitrile-butadiene-styrene (ABS). It is the integrated control center that is responsible for starting and stopping treatments, regulating pressure, and mode selection to ensure a precise and safe treatment process. The user interface is a series of buttons showing battery level, pressure level, mode adjustment. The user interface provides for:
- · Starting and stopping the massage treatment;
- · Adjusting intensity (pressure) of the treatment;
- ·Select the treatment mode.
The air compression massager is charged using® an external compliant power supply as well as powered by an internal IEC 62133-2 compliant lithium-ion battery. All four models of the Air Compression Massager are available with 800mAh, 1000mAh and 2000mAh batteries.
In addition, the devices have Bluetooth capability that allows the use of a Mobile app to control the device. The Bluetooth app allows the user to use a compatible Android or iOS phone to select and set device parameters listed above for convenience.
Differences between models:
The ACM-A1. ACM-A3 and ACM-A4 are the same, except for the color of the main unit and the shape of buttons.
The ACM-A2 is different from ACM-A1. Visually, the main unit of ACM-A2 has one more button than the other models. The ACM-A1/3/4 have only one button. The ACM-A2 model
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has two buttons, one for the on/off button and the other for the function button.
| Model | Main unit(with battery) | Sleeve | Battery | |
|---|---|---|---|---|
| ACM-A1 | Image: Main unit with battery 800mAh & 1000mAh | Image: Main unit with battery 2000mAh | Image: Sleeve | Image: Battery 800mAh& 1000mAh |
| ACM-A2 | Image: Main unit with battery 800mAh&1000mAh | Image: Main unit with battery 2000mAh | Image: Battery 2000mAh | |
| ACM-A3 | Image: Main unit with battery 800mAh&1000mAh | Image: Main unit with battery 2000mAh | XL (Extra large),L (large),M (medium)S (small). | Image: Battery 800mAh1000mAh2000mAh |
| ACM-A4 | Image: Main unit with battery 800mAh&1000mAh | Image: Main unit with battery 2000mAh |
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Specification and Parameters
| Characteristic | ACM-A1/ACM-A3/ACM-A4 | ACM-A2 |
|---|---|---|
| Software / FirmwareMicro-processor Control | Microprocessor | |
| Technology | Compressor and valve system that sequentially inflates cells.Bluetooth communication ability. | |
| Pressure range | 0-100mmHg | |
| Pressure Levels | Level 1: 60 mm HgLevel 2: 70 mm HgLevel 3: 80 mm HgLevel 4: 90 mm HgLevel 5: 100 mm Hg | |
| Treatment Time | Default: 20 minStays on until the user turns it off or can be set up to turn off in a rangeof 20 minutes to 60 minutes | |
| Inflation/DeflationCycle Type | Sequential Gradient, Peristaltic and Pulsing | |
| Number ofInflatable segments | 5 chambers | |
| Main Unit Weight | 0.4kg | |
| Main Unit Dimensions(L×W×H) | 131mm×65mm×38mm | 131mm×65mm×40mm |
| ProductDimensions(L×W×H) | S: 840mm×330mm × 55mmM: 950mm×380mm × 55mmL: 1020mm×380mm×55mmXL:1100mm× 410mm ×55mm | S: 840mm×330mm×57mmM: 950mm×380mm×57mmL: 1020mm×380mm×57mmXL:1100mm×410mm×57mm |
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| Battery | |
|---|---|
| Input Voltage | DC:5V-2A |
| Charging Interface | Type-C |
| Rated Power | 25W |
| Rated Voltage | DC:7.4V |
| Battery capacity | 800mAh |
| 1000mAh | |
| 2000mAh | |
| Working Condition | Temperature:5°C~40°C; Relative Humidity: ≤90%; |
| Atmospheric pressure: 70kPa~106kPa | |
| Transport and storage | Temperature:-20°C~50°C; Relative Humidity: ≤90%; |
| Atmospheric pressure: 70kPa~106kPa |
The component contacting the user
| Model | Component | Contacted Material | Contacted duration | Tissue |
|---|---|---|---|---|
| ACM-A1;ACM-A2;ACM-A3;ACM-A4 | Sleeve | 1. Inner and Outer cloth of the legair bag: Nylon cloth, thermopolastic polyurethane (TPU)2.Zipper: Nylon, metal3.Edge-wrapping strips: polyester fibre, polypropylene (PP) | Non-conductive wrapSurface DeviceIntact SkinLong term (>30day) | |
| Main unit | Polycarbonate (PC),Acrylonitrile-butadiene-styrene (ABS) |
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E. Indication for use
The Air Compression Massager is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.
| Item | Subject device | Predicate device | Discussion |
|---|---|---|---|
| Manufacturer | Sichuan Qianli-beoka MedicalTechnology Inc. | NormaTec Industries, LP | - |
| 510(K) No. | K241446 | K240122 | - |
| Device Name | Air compression MassagerModels: ACM-A1, ACM-A2,ACM- A3, ACM-A4 | Normatec Elite | - |
| RegulationNumber | 21 CFR 890.5650 | 21 CFR 890.5650 | Identical |
| ClassificationName | Powered inflatable tube massager | Powered inflatable tubemassager | Identical |
| RegulationClass | Class II | Class II | Identical |
| OTC& Rx | OTC | OTC | Identical |
| Indication foruse | The Air compression Massager isan air pressure massager intendedto temporarily relieve minor muscleaches and/or pains, and totemporarily increase circulation tothe treated areas. | The Normatec Elite is anairpressure massagerintended totemporarily relieve minormuscle aches and/orpains, and totemporarily increasecirculation to the treatedareas. | Identical |
| PatientPopulation | Adults | Adults | Identical |
| AnatomicalCoverage | Main unit mounted to inflatablesegment with integral hoses.Image: Main unit | Control unit mounted toinflatable segment withintegral hoses.Image: Control unit | Identical |
| Intended UseEnvironment | Clinics, hospital, athlete training,and home environments | Clinics, hospital, athletetraining, and homeenvironments | Identical |
| Powersource | 5 VDC via an IEC 60601-1compliant power supply (100-240VAC input)Integrated rechargeable battery | 12 VDC via an IEC60601-1compliantpower supply (100-240VAC input)Integrated rechargeablebattery | Similar |
| Software/Firmware Micro-processorControl | Microprocessor | Microprocessor | Identical |
| Technology | Compressor and valve system thatsequentially inflates cells.Bluetooth communication ability. | Compressor and valvesystem that sequentiallyinflates cells.Bluetoothcommunication ability. | Identical |
| Device PressureRange | 0-100mmHg | 0 - 110 mm Hg | Similar |
| Pressure Levels | Level 1: 60 m HgLevel 2: 70 mm HgLevel 3: 80 mm HgLevel 4: 90 mm HgLevel 5: 100 mm Hg | Level 1: 40 mm HgLevel 2: 50 - 60 mm HgLevel 3: 60 - 70 mm HgLevel 4: 70 - 80 mm HgLevel 5: 80 mm HgLevel 6: 80 - 90 mm HgLevel 7: 100 mm Hg | Similar;Tested tomeetperformancerequirements |
| Treatment Time | Default:20minStays on until the user turns it off orcan be set up to turn off in a rangeof 20 minutes to 60 minutes | Stays on until the userturns it off or can be setup to turn off in arange of 15 minutes to 60minutes | Similar:Tested tomeetperformancerequirements It willnot raiseany newconcerns |
| Inflation/Deflation Cycle Type | Sequential Gradient, Peristaltic and Pulsing | Sequential Gradient, Peristaltic and Pulsing | the safetyandeffectiveness.Identical |
| Contact SurfaceMaterial | Nylon cloth, thermopolasticpolyurethane (TPU) | 200 denier nylon with apolyurethanelaminate/extrusion | Similar;All havebeenevaluatedforbiocompatibilityaccordingto ISO10993and meettherequirements. |
| Number ofInflatablesegments | 5 segments for leg attachment | 5 segments for legattachment | Identical |
| Weight | 2.3-2.9 kg (5-6.4 lbs) | 3.0 lbs | Similar;Weightand |
| Main UnitDimensions(W×H ×D) | ACM-A1/3/4:131mm×65mm×38mm(5.16”×2.56”×1.50")ACM-A2:131mm×65mm×40mm(5.16”×2.56”×1.57") | 3.5" ×1.75" ×7.0" | dimensions will notraise anynewconcernsregardingthe safetyandeffectiveness |
| Patient Contact | The contact material meets the requirements of ISO 10993-1 | The contact material meets the requirements of ISO 10993-1 | Identical |
| Characteristic | Subject Device | Predicate Device | |
| Air compressionMassagerModel: ACM-A1,ACM-A2,ACM-A3,ACM-A4 | Normatec Elite | ||
| Power On – The system has settings for: | |||
| Adjustable Treatment time | X | X | |
| Inflatable Leg Boot | X | X | |
| Pressure Levels | 5 Pressure Levels | 7 Pressure Levels | |
| 5 zone Inflatable leg boot | X | X | |
| Time | |||
| User can Add timeBefore treatmentDuring treatment | X | X | |
| User can Decrease timeBefore treatmentDuring treatment | X | X | |
| Pressure | |||
| User can Increase levelBefore treatmentDuring treatment | X | X | |
| User can Decrease levelBefore treatmentDuring treatment | X | X | |
| Treatment Mode | |||
| Treatment Mode | X | X | |
| Treatment | |||
| Starting via button press | X | X | |
| Pause/Stop via button press | X | X | |
| Un-pause via button press | X | X | |
| End - If timer reaches 0:0000, | X | X |
F. Comparison to predicate device
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Differences Between Predicate and Subject Device
An "X" indicates the feature is present in the device.
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Sichuan QianIi-beoka Medical TechnoIogy Inc. Longtan Industrial Park 2nd Sec,east 3rd ring road,Chenghua district,Chengdu,
| × | X | |
|---|---|---|
| X | ||
| × | × | |
| × | × | |
| × | × | |
| Selection of appliance - Inflatable X | X | |
| × |
G. Substantial Equivalent discussion
The technology and principle of operation is similar for the proposed device when compared to the predicate device. Both have 5 segments for leg attachment, use the Compressor and valve system that sequentially inflates cells, and have Bluetooth communication ability.
The main unit is mounted to inflatable segment with integral hoses. The treatment time can be controlled, and all three treatment modes are available. Stress can be regulated. Both are powered by an integrated rechargeable battery, charged via an IEC 60601-1 compliant power supply (100- 240 VAC input).
Differences between Subject and Predicate Device Discussion-
The main differences between the products are dimensions, materials, and main units. The subject device met the requirements of IEC 60601-1, IEC 60601-1-2 and IEC 60601-1-11. The subject device meets the biocompatibility requirements of ISO 10993-5:2009 & ISO 10993-10:2021 & ISO 10993-23:2021.
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Sichuan QianIi-beoka Medical TechnoIogy Inc. Longtan Industrial Park 2nd Sec,east 3rd ring road,Chenghua district,Chengdu,
Discussion of Differences:
The differences between the subject and predicate device do not raise any new concerns reqarding the safety and effectiveness as demonstrated by performance testing.
H. Performance characteristic
The Air Compression Massager has been tested and met the requirements of the following standards:
- IEC 60601-1:2005+AMD1:2012+AMD2:2020 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2 Edition 3: 2007-03, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 60601-1-11:2015+AMD1:2020 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/TS 60601-4-2:2024 Medical electrical equipment Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
- · IEEE ANSI/USEMCSC C63.27 Wireless Coexistence
- · ISO10993-5:2009 Biological evaluations of medical devices -- Part 5: Tests for In Vitro cvtotoxicity
- · ISO 10993-10:2021 Biological evaluation of medical devices Part 10: Tests for skin sensitization
- · ISO 10993-23:2021 Biological Evaluation of Medical Devices Part 23: Tests for irritation
Additionally, the Air Compression Massager has been tested for the following performance bench testing:
- Pressure accuracy testing ●
Seam strength testing to ensure cuffs do not burst if maximum pressure is exceded Failure mode verification and validation testing to ensure mitigation of overpressurization risk if there is software failure
l. Conclusion
Based on the above data, we can conclude tha"t the subject device Air Compression Massager is as safe and effective as the predicate devices. Thus, the subject device is substantially equivalent to the predicate devices cleared under K240122.
§ 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).