(145 days)
Not Found
No
The description mentions a microprocessor and sensor for controlling the device's function, but there is no mention of AI, ML, or any learning or adaptive capabilities. The operation appears to be based on pre-programmed sequential inflation/deflation cycles.
No.
The intended use states it is for temporary relief of minor muscle aches and pains and to increase circulation, which are non-therapeutic claims.
No
Explanation: The device is an air compression leg massager intended to relieve muscle aches and pains and increase circulation. It does not perform any diagnostic functions such as detecting, monitoring, or analyzing physiological parameters for the purpose of disease diagnosis or intervention.
No
The device description explicitly states it consists of hardware components like an air pressure sensor, air pump, and sleeves, working together as a unit.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "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 from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a mechanical device that uses air compression to massage the legs. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There is no mention of diagnostic purposes.
Therefore, the Air compression leg massager HY-1117A falls under the category of a physical therapy or massage device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Air compression leg massager HY-1117A is intended for home to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas in people who are in good health.
Product codes (comma separated list FDA assigned to the subject device)
IRP
Device Description
Air compression leg massager HY-1117A 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. Air compression leg massager HY-1117A, in medical market, it has a sequential squeezing from distal to proximal, thus help to improve circulation to the treated areas.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
leg
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing - Clinical: Not Applicable.
Performance Testing - Animal: Not Applicable.
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 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.
January 18, 2022
Xiamen High Top Electronic Technology Co., Ltd. % Sam Lin Official Correspondent Shanghai Spica Management Consulting Co., Ltd. 609 Room, No.133 Shengang Avenue, Pudong New District Shanghai. 201306 China
Re: K212713
Trade/Device Name: Air compression leg massager HY-1117A Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: January 5, 2022 Received: January 5, 2022
Dear Sam Lin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Heather 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
2
Indications for Use
510(k) Number (if known) K212713
Device Name
Air compression leg massager HY-1117A
Indications for Use (Describe)
Air compression leg massager HY-1117A is intended for home to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas in people who are in good health.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
| Type of Submission | Traditional |
|---|---|
| Date Prepared | June 25, 2021 |
| Submission Sponsor | |
| Manufacturer Name | Xiamen High Top Electronic Technology Co., Ltd. |
| Address | F2-5 No. 118 Siming Park, Tong'an Industrial Zone, |
| Xiamen, Fujian, China | |
| Tel | 86-15359228717 |
| 181492777@qq.com | |
| Contact Person | Liangsan Zhao |
| Application Correspondent | |
| Company Name | Shanghai Spica Management Consulting Co., Ltd. |
| Address | 609 Room, No.133 Shengang Avenue, Pudong New |
| District, Shanghai, China | |
| Tel | 86-15626132181 |
| sam@spicagloble.com | |
| Contact Person | Sam Lin |
| Device Identification | |
| Trade Name | Air compression leg massager HY-1117A |
| 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 |
Air compression leg massager HY-1117A is intended for home to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas in people who are in good health.
Device Description
4
Air compression leg massager HY-1117A 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. Air compression leg massager HY-1117A, in medical market, it has a sequential squeezing from distal to proximal, thus help to improve circulation to the treated areas.
Predicate and Reference Device Information
| Sponsor | Shenzhen Dongjilian Electronics Co., Ltd. |
|---|---|
| Trade/Device Name | Air Compression Therapy Device |
| 510(K) number | K193354 |
| Regulation Number | 21 CFR 890.5650 |
Performance Testing - Clinical
Not Applicable.
Performance Testing - Animal
Not Applicable.
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Table 6A: Summary of Comparison
| Subject Device | Predicate Device | Differences Discussion | |
|---|---|---|---|
| Device name | Air compression leg massager HY-1117A | Air Compression Therapy Device | N/A |
| 510(k) | |||
| number | K212713 | K193354 | N/A |
| Manufacturer | Xiamen High Top Electronic Technology | ||
| Co., Ltd. | Shenzhen Dongjilian Electronics | ||
| Co., Ltd. | N/A | ||
| Product | |||
| regulation | 21 CFR 890.5650 | 21 CFR 890.5650 | Same |
| Classification | |||
| name | Massager, Powered Inflatable Tube | Massager, Powered Inflatable | |
| Tube | Same | ||
| Regulation | |||
| class | 2 | 2 | Same |
| Product code | IRP | IRP | Same |
| Indications for | |||
| use | Air compression leg massager HY-1117A is | ||
| intended for home to temporarily relieve | |||
| minor muscle aches and/or pains, and to | |||
| temporarily increase circulation to the | |||
| treated areas in people who are in good | |||
| health. | The Air Compression Therapy | ||
| Device is indicated for the | |||
| temporary relief of minor muscle | |||
| aches and pains and for | |||
| temporary increase in circulation | |||
| to the treated areas in people who | |||
| are in good health. The Air | |||
| Compression Therapy Device | |||
| simulates kneading and stroking | |||
| of tissues by using an inflatable | |||
| garment. | Same | ||
| Rx or OTC | OTC | OTC | Same |
| Pressure range | 0-240mmHg | 0~240mmHg | Same |
| Treatment | |||
| time | 15 minutes | 20 minutes | Similar |
| The treatment time of subject device is smaller than | |||
| predicate device (K193354), so the difference of | |||
| treatment time would not raise adversely impact on | |||
| safety and effectiveness. | |||
| Standard | ANSI AAMI ES60601-1:2005/(R)2012 and | ||
| A1:2012, C1:2009/(R)2012 and | |||
| A2:2010/(R)2012, IEC 60601-1-2, IEC | |||
| 60601-1-11, ISO 10993-5, ISO 10993-10 | ES 60601-1; | ||
| IEC60601-1-2; | |||
| ISO 10993-5: | |||
| ISO 10993-10; | |||
| IEC 60601-1-11 | Similar | ||
| Mode of | |||
| compression | Sequential | Sequential/ Peristaltic | Same |
| Power source | 100~240V 50/60Hz | 100~240V 50/60Hz | Same |
| Power | |||
| consumption | 24W | 12W | Similar |
| Dimensions | |||
| (WHD) | 111624.9inch | 10.2×5.9×25.6inch | Similar |
| Photo | Image: Leg compression sleeves and controller | Image: Handheld controller | Similar |
| Similar | |||
| Housing | |||
| materials | Molded ABS enclosure | Molded ABS enclosure | Same |
| Number of | |||
| chambers | 3 | 3 | Same |
| Work mode | Six modes: | ||
| Full leg 1(F1) | |||
| Full leg 2(F2) | |||
| Full leg 3(F3) | |||
| Separate part 1(M1) | |||
| Separate part 2(M2) | |||
| Separate part 3(M3) | Mode 1: | ||
| Starting with the foot chamber | |||
| and progressing up the thigh | |||
| chamber, each section | |||
| compresses and the pressure | |||
| gradually rises to the | |||
| pre-determined air pressure level, | |||
| then decompresses and the | |||
| air pressure drops. | |||
| Once the thigh section | |||
| decompresses, the cycle begins | |||
| again. | |||
| Mode 1 follows this pressure | |||
| sequence: | Although the subject device provides 6 kinds of | ||
| work mode, the Mode F1, F2, F3, M1, M2, M3 are | |||
| the similar with predicate device (K193354), while | |||
| the subject device just have difference about | |||
| inflatable order of the different chambers. The | |||
| treatment pressure range are the same under | |||
| different work modes, so the difference of pressure | |||
| range would not raise adversely impact on safety | |||
| and effectiveness. |
6
7
8
Image /page/8/Picture/1 description: The image shows a diagram of a compression garment and text describing the garment's modes of operation. Mode 2 starts with the foot chamber and progresses up the thigh, with each section compressing and the pressure gradually rising to the pre-determined air pressure level. All three sections then decompress simultaneously and the air pressure drops, then the cycle begins again. Mode 3 is also mentioned in the text.
9
| | | include two stage, stage 1: it
work according to the method of
mode 1, after the stage 1 is
completed, it go to stage
2(working according to the
method of mode 2) without
interruption time until finish the
stage 2, then enter next cycle
without interruption .
Mode1 $\rightleftharpoons$ Mode2
The pressure sequence of mode 3
combines mode 1 and mode 2 | |
|----------------|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Safety feature | Button on display allows user to stop or
pause therapy session at any time | Button on display allows user to
stop or pause therapy session at
any time | Same |
| Technology | Compressor and valve system which
sequentially inflates inflatable chambers | Compressor and valve system
which sequentially inflates
inflatable chambers | Same |
10
Summary of the technological characteristics of the device
The device meets all the applicable technical requirements of : IEC 60601-1-11: 2015 - Medical electrical equipment - Part 1-11: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment IEC 60601-1-2: 2014 - Medical electrical equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 -Medical electrical equipment - Part 1: General requirements for basic safety and essential performance ISO 10993-5: 2009 - Biological Evaluation of Medical Device - Part 5: Tests for in vitro Cytotoxicity ISO 10993-10: 2010 - Biological Evaluation of Medical Devices - Part 10: Tests for irritation and skin sensitization
Conclusion
Based on the indications for use, technological characteristics, and non-clinical performance data, "Air compression leg massager HY-1117A (K212713)" is as safe, as effective, and performs as well as the legally marketed predicate devices, "Air Compression Therapy Device (K193354)". Therefore, the subject device is substantially equivalent to the predicate device.