(139 days)
Not Found
No
The description focuses on mechanical air pressure, user-controlled settings, and standard electrical/wireless components. There is no mention of AI/ML terms, data analysis for personalized treatment, or adaptive algorithms based on user input or physiological data.
Yes.
The device is intended to temporarily relieve minor muscle aches and pains and temporarily increase circulation, which are therapeutic claims.
No
The device is described as an air pressure massager intended to provide temporary relief from muscle aches and increase circulation, which are therapeutic functions, not diagnostic ones.
No
The device description clearly outlines physical components like a sleeve, main unit, and battery, and describes their materials and functions. While it has a mobile app for control, the core therapeutic function is delivered through hardware (air pressure inflation/deflation).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 describes a physical therapy or massage device, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a device that applies air pressure to the legs for massage. It does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.).
- Anatomical Site: The device is applied externally to the legs and associated areas. IVDs typically interact with internal biological samples.
- Performance Studies: The listed performance studies focus on electrical safety, electromagnetic compatibility, biocompatibility, and mechanical performance (pressure accuracy, seam strength). These are typical tests for physical therapy or medical devices, but not for IVDs, which would involve analytical and clinical performance studies related to the analysis of biological samples.
In summary, the Air Compression Massager is a therapeutic device that applies physical pressure to the body. It does not perform any diagnostic testing on biological specimens, which is the defining characteristic of an In Vitro Diagnostic device.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
IRP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
legs, foot/ankle, calf, knee, lower quad and upper quad
Indicated Patient Age Range
Adults
Intended User / Care Setting
Clinics, hospital, athlete training, and home environments
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The device was 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
Key Results: All tests demonstrated that the subject device Air Compression Massager is as safe and effective as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 & 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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).
1
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).
2
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
3
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
5
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
6
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 800mAh | |||
| 1000mAh | ||||
| 2000mAh | ||||
| 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 / Firmware | ||
| Micro-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 Hg | |
| Level 2: 70 mm Hg | ||
| Level 3: 80 mm Hg | ||
| Level 4: 90 mm Hg | ||
| Level 5: 100 mm Hg | ||
| Treatment Time | Default: 20 min | |
| Stays on until the user turns it off or can be set up to turn off in a range | ||
| of 20 minutes to 60 minutes | ||
| Inflation/Deflation | ||
| Cycle Type | Sequential Gradient, Peristaltic and Pulsing | |
| Number of | ||
| Inflatable segments | 5 chambers | |
| Main Unit Weight | 0.4kg | |
| Main Unit Dimensions | ||
| (L×W×H) | 131mm×65mm×38mm | 131mm×65mm×40mm |
| Product | ||
| Dimensions | ||
| (L×W×H) | S: 840mm×330mm × 55mm | |
| M: 950mm×380mm × 55mm | ||
| L: 1020mm×380mm×55mm | ||
| XL:1100mm× 410mm ×55mm | S: 840mm×330mm×57mm | |
| M: 950mm×380mm×57mm | ||
| L: 1020mm×380mm×57mm | ||
| XL: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 leg | ||
| air bag: Nylon cloth, thermopolastic polyurethane (TPU) | ||||
| 2.Zipper: Nylon, metal | ||||
| 3.Edge-wrapping strips: polyester fibre, polypropylene (PP) | Non-conductive wrap | |||
| Surface Device | ||||
| Intact Skin | ||||
| Long term (>30day) | ||||
| Main unit | Polycarbonate (PC), | |||
| Acrylonitrile-butadiene-styrene (ABS) |
9
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 Medical | ||
| Technology Inc. | NormaTec Industries, LP | - | |
| 510(K) No. | K241446 | K240122 | - |
| Device Name | Air compression Massager | ||
| Models: ACM-A1, ACM-A2, | |||
| ACM- A3, ACM-A4 | Normatec Elite | - | |
| Regulation | |||
| Number | 21 CFR 890.5650 | 21 CFR 890.5650 | Identical |
| Classification | |||
| Name | Powered inflatable tube massager | Powered inflatable tube | |
| massager | Identical | ||
| Regulation | |||
| Class | Class II | Class II | Identical |
| OTC& Rx | OTC | OTC | Identical |
| 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. | The Normatec Elite is an | ||
| air | |||
| pressure massager | |||
| intended to | |||
| temporarily relieve minor | |||
| muscle aches and/or | |||
| pains, and to | |||
| temporarily increase | |||
| circulation to the treated | |||
| areas. | Identical | ||
| Patient | |||
| Population | Adults | Adults | Identical |
| Anatomical | |||
| Coverage | Main unit mounted to inflatable | ||
| segment with integral hoses. | |||
| Image: Main unit | Control unit mounted to | ||
| inflatable segment with | |||
| integral hoses. | |||
| Image: Control unit | Identical | ||
| Intended Use | |||
| Environment | Clinics, hospital, athlete training, | ||
| and home environments | Clinics, hospital, athlete | ||
| training, and home | |||
| environments | Identical | ||
| Power | |||
| source | 5 VDC via an IEC 60601-1 | ||
| compliant power supply (100-240 | |||
| VAC input) | |||
| Integrated rechargeable battery | 12 VDC via an IEC | ||
| 60601-1compliant | |||
| power supply (100-240 | |||
| VAC input) | |||
| Integrated rechargeable | |||
| battery | Similar | ||
| Software/Firmw | |||
| are Micro- | |||
| processor | |||
| Control | Microprocessor | Microprocessor | Identical |
| Technology | Compressor and valve system that | ||
| sequentially inflates cells. | |||
| Bluetooth communication ability. | Compressor and valve | ||
| system that sequentially | |||
| inflates cells. | |||
| Bluetooth | |||
| communication ability. | Identical | ||
| Device Pressure | |||
| Range | 0-100mmHg | 0 - 110 mm Hg | Similar |
| Pressure Levels | Level 1: 60 m Hg | ||
| Level 2: 70 mm Hg | |||
| Level 3: 80 mm Hg | |||
| Level 4: 90 mm Hg | |||
| Level 5: 100 mm Hg | Level 1: 40 mm Hg | ||
| Level 2: 50 - 60 mm Hg | |||
| Level 3: 60 - 70 mm Hg | |||
| Level 4: 70 - 80 mm Hg | |||
| Level 5: 80 mm Hg | |||
| Level 6: 80 - 90 mm Hg | |||
| Level 7: 100 mm Hg | Similar; | ||
| Tested to | |||
| meet | |||
| performan | |||
| ce | |||
| requirements | |||
| Treatment Time | Default:20min | ||
| Stays on until the user turns it off or | |||
| can be set up to turn off in a range | |||
| of 20 minutes to 60 minutes | Stays on until the user | ||
| turns it off or can be set | |||
| up to turn off in a | |||
| range of 15 minutes to 60 | |||
| minutes | Similar: | ||
| Tested to | |||
| meet | |||
| performance | |||
| requirements It will | |||
| not raise | |||
| any new | |||
| concerns | |||
| Inflation/Deflatio | |||
| n Cycle Type | Sequential Gradient, Peristaltic and Pulsing | Sequential Gradient, Peristaltic and Pulsing | the safety |
| and | |||
| effectivene | |||
| ss. | |||
| Identical | |||
| Contact Surface | |||
| Material | Nylon cloth, thermopolastic | ||
| polyurethane (TPU) | 200 denier nylon with a | ||
| polyurethane | |||
| laminate/extrusion | Similar; | ||
| All have | |||
| been | |||
| evaluated | |||
| for | |||
| biocompa | |||
| tibility | |||
| according | |||
| to ISO | |||
| 10993 | |||
| and meet | |||
| the | |||
| requirem | |||
| ents. | |||
| Number of | |||
| Inflatable | |||
| segments | 5 segments for leg attachment | 5 segments for leg | |
| attachment | Identical | ||
| Weight | 2.3-2.9 kg (5-6.4 lbs) | 3.0 lbs | Similar; |
| Weight | |||
| and | |||
| Main Unit | |||
| Dimensions | |||
| (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" | dimension | |
| s will not | |||
| raise any | |||
| new | |||
| concerns | |||
| regarding | |||
| the safety | |||
| and | |||
| effectiven | |||
| ess | |||
| 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 compression | |||
| Massager | |||
| Model: 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 time | |||
| Before treatment | |||
| During treatment | X | X | |
| User can Decrease time | |||
| Before treatment | |||
| During treatment | X | X | |
| Pressure | |||
| User can Increase level | |||
| Before treatment | |||
| During treatment | X | X | |
| User can Decrease level | |||
| Before treatment | |||
| During 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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11
12
Differences Between Predicate and Subject Device
An "X" indicates the feature is present in the device.
13
14
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.