(168 days)
No
The description details a pneumatically controlled system with preset program parameters, monitored by a pressure sensor and microprocessor. There is no mention of learning, adaptation, or complex pattern recognition characteristic of AI/ML.
Yes
The device is intended for the temporary relief of minor muscle aches and for temporary increase in circulation, which are therapeutic claims. It also references predicate devices that are described as "Air Compression Therapy Device".
No
The device is indicated for temporary relief and increased circulation, not for diagnosing medical conditions.
No
The device description explicitly details hardware components including an air pump unit, battery, control components housed in a plastic case, function buttons, LED indicators, ports, air hoses, and inflatable leg wraps with air bladders. While it mentions an electronically controlled air pump and microprocessor, the core functionality relies on physical components to deliver the therapy.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- This device is an Air Compression Leg Massager. Its intended use is for temporary relief of minor muscle aches and temporary increase in circulation to treated areas. It works by applying external pressure to the legs.
The description clearly indicates it's a physical therapy/massage device, not a device that analyzes biological samples. The performance studies listed are related to electrical safety, battery safety, electromagnetic compatibility, home healthcare environment requirements, and biocompatibility with skin contact, all of which are relevant for a device that interacts externally with the body, not for an IVD.
N/A
Intended Use / Indications for Use
Air Compression Leg Massager is indicated for the temporary relief of minor muscle aches and for temporary increase in circulation to the treated areas in good health. Air Compression Leg Massager simulates kneading and stroking of tissues by using an inflatable garment.
Product codes
IRP
Device Description
Air Compression Leg Massager (Model: EMK-701) is a portable and rechargeable device. It is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading and stroking of tissue with the hands by use of inflatable pressure cuffs. It can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains. Air Compression Leg Massager supplied clean and non-sterile, utilizes the pneumatically controlled leg wraps actuated by an electronically controlled air pump unit. A pump, battery and control components are protectively housed in a plastic case of Handheld Controller. Function buttons and light emitting diode (LED) indicators on the Handheld Controller make up the user interface. There are 3 ports at the bottom of Handheld Controller for connecting the alternating current (AC) adapter plug and two air hoses. Each leg wrap has an air hose for connection to Handheld Controller, and both encase a 2-chamber air bladder inside. Feet and calves can be wrapped and massaged separately by the two chambers. The soft medical fabric of wraps provides patient comfort and biocompatibility compliance. In operation, the user turns the power on via the Power button. Then the Handheld Controller controls the inflating and deflating of the air bladders according to preset program parameters. The air pressure is monitored by an internal pressure sensor and microprocessor. Once the pressure of the air bladder reaches the proper level, the pump is turned off for a rest period. The cycle of inflation and deflation repeats until the unit is turned off.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Leg (feet, calves)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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
No Clinical Test conducted.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). The logo consists of two parts: a symbol on the left and the text on the right. The symbol on the left is a stylized representation of a human figure. The text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The words "U.S. FOOD & DRUG" are on the top line, and the word "ADMINISTRATION" is on the bottom line.
March 15, 2023
Xiamen Emoka Health Science & Technology Co., Ltd. Iris Fung Regulation Manager 6F, No.1 TianTai road, Science City, LuoGang District Guangzhou, Guangdong 361000 China
Re: K222991
Trade/Device Name: Air Compression Leg Massager (model: EMK-701) Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: Class II Product Code: IRP Dated: September 28, 2022 Received: September 28, 2022
Dear Iris Fung:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 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).
Sincerely,
Tushar Bansal -S
for Heather Dean, PhD Assistant Director THT5B3: 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) K22991
Device Name
Air Compression Leg Massager (model: EMK-701)
Indications for Use (Describe)
Air Compression Leg Massager is indicated for the temporary relief of minor muscle aches and for temporary increase in circulation to the treated areas in good health. Air Compression Leg Massager simulates kneading and stroking of tissues by using an inflatable garment.
| 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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Date of the summary prepared: Mar 10, 2023
510(k) Summary
510K: K222991
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92. This is a Traditional 510(K) submission, and there were no prior submissions for the subject device.
1. Submitter'sInformation
Sponsor
- � Company Name: Xiamen Emoka Health Science & Technology Co., Ltd.
- Address: D Building, No.100, Jinfu Road, Chengnan Industrial Zone, Tong'an District, � Xiamen, China
- � Phone: +86-592-7363861
- � Email: emk@emoka.cn
- Contact Person (including title): Zhang Feng (Quality Manager) �
Application Correspondent:
- Xiamen Emoka Health Science & Technology Co., Ltd.. �
- � Address: D Building, No.100, Jinfu Road, Chengnan Industrial Zone, Tong'an District, Xiamen, China
- � Contact Person: Ms. Iris Fung
- Title: Regulation Manager �
- � Tel: +86-18588874857
- � Email: mdc-fs@foxmail.com; jianda-lee@foxmail.com
Subject Device Information 2.
- Type of 510(k) submission: Traditional �
- Classification: Powered Inflatable Tube Massager �
- � Trade Name: Air Compression Leg Massager
- � Model: EMK-701
- � Review Panel: Physical Medicine
- Product Code: IRP �
- Requlation Number: 21 CFR 890.5650 �
- Regulation Class: 2 �
3. Predicate Device Information
Predicate Device I
- 510(k) number: K193354 �
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- � Sponsor: Shenzhen Donqiilian Electronics Co., Ltd.
- Classification: Powered Inflatable Tube Massager �
- Trade Name: Air Compression Therapy Device � Model: S9019
- � Review Panel: Physical Medicine
- Product Code: IRP �
- � Regulation Number: 21 CFR 890.5650
- Regulation Class: 2 �
Predicate Device II
- 510(k) number: K212935 �
- Sponsor: Xiamen Simo Electronic Co., Ltd �
- � Classification: Powered Inflatable Tube Massager
- Trade Name: Air Pressure Foot Massager �
- � Model: SM-512F
- Review Panel: Physical Medicine �
- � Product Code: IRP
- Regulation Number: 21 CFR 890.5650 �
- Regulation Class: 2 �
4. Device Description
Air Compression Leg Massager (Model: EMK-701) is a portable and rechargeable device. lt is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading and stroking of tissue with the hands by use of inflatable pressure cuffs. It can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains.
Air Compression Leg Massager supplied clean and non-sterile, utilizes the pneumatically controlled leg wraps actuated by an electronically controlled air pump unit. A pump, battery and control components are protectively housed in a plastic case of Handheld Controller. Function buttons and light emitting diode (LED) indicators on the Handheld Controller make up the user interface. There are 3 ports at the bottom of Handheld Controller for connecting the alternating current (AC) adapter plug and two air hoses.
Each leg wrap has an air hose for connection to Handheld Controller, and both encase a 2chamber air bladder inside. Feet and calves can be wrapped and massaged separately by the two chambers. The soft medical fabric of wraps provides patient comfort and biocompatibility compliance.
In operation, the user turns the power on via the Power button. Then the Handheld Controller controls the inflating and deflating of the air bladders according to preset program
5
parameters. The air pressure is monitored by an internal pressure sensor and microprocessor. Once the pressure of the air bladder reaches the proper level, the pump is turned off for a rest period. The cycle of inflation and deflation repeats until the unit is turned off.
5. Intended Use / Indicationsfor Use
Air Compression Leg Massager 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. Air Compression Leg Massager simulates kneading and stroking of tissues by using an inflatable garment.
6. Test Summary
Air Compression Leg Massager has been evaluated for its safety and performance by lab bench testing as following:
- � ANSI/AAMI ES60601-1:2012, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
- � IEC 62133-2:2017, Secondary cells and batteries containing alkaline or other nonacid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
- � IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility
- ◆ 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
- � ISO 10993-5:2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity
- � ISO 10993-10:2010, Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
7. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, and intended use of Air Compression Leg Massager is substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| Elements of
| comparison | Subject Device | Predicate Device I | Predicate Device II | Comparison |
|---|---|---|---|---|
| Manufacturer | Xiamen Emoka Health | |||
| Science & Technology Co., | ||||
| Ltd. | Shenzhen Dongjilian | |||
| Electronics Co., Ltd. | Xiamen Simo Electronic Co., | |||
| Ltd | -- | |||
| 510K number | K222991 | K193354 | K212935 | -- |
| Elements of | ||||
| comparison | Subject Device | Predicate Device I | Predicate Device II | Comparison |
| Product Name | Air Compression Leg | |||
| Massager | ||||
| BMK-701 | Air Compression Therapy | |||
| Device | ||||
| S9019 | Air Pressure Foot Massager | |||
| SM-512F | -- | |||
| Classification | ||||
| Name | Pow ered inflatable tube | |||
| massager | Pow ered inflatable tube | |||
| massager | Pow ered inflatable tube | |||
| massager | -- | |||
| Regulation | ||||
| Class | 2 | 2 | 2 | -- |
| Product code | IRP | IRP | IRP | -- |
| Regulation | ||||
| Number | 21 CFR 890.5650 | 21 CFR 890.5650 | 21 CFR 890.5650 | -- |
| OTC & Rx | OTC | OTC | OTC | Same |
| Indications for | ||||
| Use | Air Compression Leg | |||
| Massager 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. Air Compression Leg | ||||
| Massager simulates kneading | ||||
| and stroking of tissues by | ||||
| using an inflatable garment. | 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 w ho are in | ||||
| good health. The Air | ||||
| Compression Therapy Device | ||||
| simulates kneading and | ||||
| stroking of tissues by using | ||||
| an inflatable garment. | Air Pressure Foot Massager is | |||
| intended to temporarily relieve | ||||
| minor muscle aches and/or | ||||
| pains, and to temporarily | ||||
| increase circulation to the | ||||
| treated areas. | Minor | |||
| difference | ||||
| Note 1 | ||||
| Pow er Source | Input: AC100-240V, 50/60Hz | |||
| Output: DC 13.5V, 1A | ||||
| Internal battery: 11.1V, | ||||
| 1000mAh | 100~240V 50/60Hz | Voltage: DC5V 1A Lithium | ||
| Battery: 3.7V, 2400mah | Minor | |||
| difference | ||||
| Note 2 | ||||
| Pow er | ||||
| consumption | 13.5 W | 12W | 5W | Minor |
| difference | ||||
| Note 2 | ||||
| Dimensions | ||||
| (WHD) | 2155070 mm | 10.2*5.9 *25.6 inch | 2115550mm | Minor |
| difference | ||||
| Note 2 | ||||
| Photo | Image: Air Compression Leg Massager | Image: Air Compression Therapy Device | Not publicly available | Minor |
| difference | ||||
| Note 2 | ||||
| Weight | 2.0 Kg (4.4pounds) | 4.6 pounds | 1.15±0.1kg | Minor |
| difference | ||||
| Note 2 | ||||
| Housing | ||||
| Materials | Molded ABS enclosure | Molded ABS enclosure | Not publicly available | Same |
| Sleeves | ||||
| Dimensions | Leg Wrap: 730*468 mm | Leg Wrap: 730*260 mm | 340365360mm | Minor |
| difference | ||||
| Elements of | ||||
| comparison | Subject Device | Predicate Device I | Predicate Device II | Comparison |
| Image: Subject Device | Image: Predicate Device I | Note 3 | ||
| Application area | Leg (feet, calves) | Leg (feet, calve, thigh) | Feet | Minor |
| difference | ||||
| Note 3 | ||||
| Number of | ||||
| Chambers | 2-chamber | 3-chamber | 2-chamber | Minor |
| difference | ||||
| Note 3 | ||||
| Sleeve | ||||
| Materials | Dacron | Nylon with a Polyurethane | ||
| laminate | Terylene | Minor | ||
| difference | ||||
| Note 3 | ||||
| Mode of | ||||
| Compression | Sequential | Sequential / Peristaltic | Sequential | Same |
| Air Pressure | ||||
| Level | Low level: 120mmHg | |||
| Medium level: 170mmHg | ||||
| High level: 210mmHg | ||||
| Error range: ±25mmHg | Low level: 150mmHg; | |||
| Mid level: 185mmHg; | ||||
| High Level: 215mmHg | ||||
| Error range: ±25mmHg | 30-110mmHg | Minor | ||
| difference | ||||
| Note 4 | ||||
| Treatment Time | 15 minutes | 20 minutes | 0-30min, default as 15min | Minor |
| difference | ||||
| Note 5 | ||||
| Inflation time | 5 – 18 s | 3 – 30 s | Not publicly available | Minor |
| difference | ||||
| Note 6 | ||||
| Keep time | 2 - 5 s | 1 - 5s | Not publicly available | |
| Deflation time | 2 – 5 s | 1 - 5s | Not publicly available | |
| Cycle time | Range of 26 sec to 1 min 29 | |||
| sec | Range of 25 sec to 3 min 40 | |||
| sec | Not publicly available | |||
| Work Mode | Mode 1: | |||
| The model is divided into | ||||
| three processes. The first | ||||
| process is starting with foot | ||||
| chamber inflates and holds | ||||
| the air until the calf chamber | ||||
| is compressed. Then deflates | ||||
| simultaneously. The second | ||||
| process is starting with foot | ||||
| chamber inflates and holds | ||||
| the air until the calf chamber | 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 | Mode 1 | |||
| The model is divided into two | ||||
| processes, the first process | ||||
| includes inflating, deflating | ||||
| and holding pressure. The | ||||
| inflating sequence of air | ||||
| chambers of sleeves is: The | ||||
| chamber No.(1) Inflate and | ||||
| keep pressure three times, | ||||
| deflated, Then the chamber | Minor | |||
| difference | ||||
| Note 6 | ||||
| Elements of | Subject Device | Predicate Device I | Predicate Device II | Comparison |
| comparison | ||||
| is compressed. Then calf | ||||
| chamber deflates, and finally | ||||
| foot chamber deflates. The | ||||
| third process is starting with | ||||
| calf chamber inflates and | ||||
| deflates then. | ||||
| Mode 1 follows this pressure | ||||
| sequence: Foot → Foot + Calf | ||||
| → Interval → Foot → Foot + | ||||
| Calf → Foot → Interval → Calf |
Mode 2:
In this model, foot chamber
and calf chamber are inflated
and deflated at the same time.
Mode 2 follows this pressure
sequence:
Foot + Calf → Interval → Foot
- Calf
The inflating and deflating
time are different according to
the intensity selected. | begins again. Mode 1 follows
this pressure sequence:
Image: pressure sequence diagram
Mode 2:
Starting with the foot chamber
and progressing up the thigh,
each section compresses and
the pressure gradually rises to
the pre-determined air
pressure level, holds the air
until the entire garment is
compressed. All three sections
then decompress
simultaneously and the air
pressure drops, then cycle
begins again. Mode 2 follows
this pressure sequence:
Image: pressure sequence diagram
Mode 3:
include two stage, stage 1: it
works according to the method
of mode 1, after the stage 1 is
completed, it goes 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. The
pressure sequence of mode 3
combines mode 1 and mode 2 | No ② inflate and keep
pressure three times, deflated.
In the second process, the air
pump is always opened, and
the air is inflated and deflated
according to the following
inflating sequence: ① ②
②-①-②-①-②-①
-①-②-①-②-①-②-①
②
①-②-①
The inflating time is different
according to the intensity
selected.
Mode 2
In this model, at first, the
chamber No. ① inflate and
keep pressure four times, then
chamber No. ①② are
inflated and deflated at the
same time. Mode 3
The chamber No. ①② are
inflated and deflated at the
same time, Then the cycle
repeats | |
| Noise level | ≤ 65 dB | ≤ 65 dB | Not publicly available | Same |
| Patient contact | Non-conductive appliances | Non-conductive appliances | Not publicly available | Same |
| Elements of
comparison | Subject Device | Predicate Device I | Predicate Device II | Verdict |
| Software/Firmware
Microprocessor
Control | Microprocessor | Microprocessor | Not publicly available | Same |
| Technology | Compressor and valve
system which sequentially
inflates cells of appliance | Not publicly available | Compressor and valve system
which sequentially inflates
cells of appliance | Same |
| Safety Features | Power button allows user to
stop therapy session at any
time | Standby button allows user to
stop therapy session at any
time | Not publicly available | Same |
| Operating
environment | Temperature: 5°C-40°C
Humidity: 5%-90% non-
condensing | Temperature: 5°C-40°C
Humidity: 5%-90% non-
condensing | Not publicly available | Same |
| Transportation &
Storage
environment | Temperature: -20°C55°C55°C
Humidity: 5%-90%
noncondensing
Atmospheric Pressure: 75-
106kPa | Temperature: 20°C
Humidity: 5%-90%
noncondensing
Atmospheric Pressure: 75-
106kPa | Not publicly available | Minor
difference
Note 2 |
| Electrical safety,
EMC | ANSI/AAMI ES60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 61233 | ES 60601-1
IEC 60601-1-2
IEC 60601-1-11 | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 61233 | Same |
| Biocompatibility | ISO 10993-5
ISO 10993-10 | ISO 10993-5
ISO 10993-10 | ISO 10993-5
ISO 10993-10 | Same |
6
7
8
9
Comparison in Detail(s):
Note 1
Although there are minor differences in the indications for use when compared to the predicate devices, the intended use is the same. This difference does not affect the safety and effectiveness.
Note 2
Although the subject device design and specification parameter between the predicate devices and subject device are different, all complied with the 60601-1 standard. So the differences on such parameters (power, dimensions, appearance,) do not affect the safety and effectiveness.
Note 3
Although the subject device provides 2-chamber wraps for the feet and calves area, which are differents in size and appearance when compared to the predicate devices, the chamber number and applicable body areas are included in the predicate devices, and the material also complies with the applicable ISO 10993-5 and ISO 10993-10 standards. Therefore, the difference does not impact safety and effectiveness.
10
Note 4
Although the pressure range of subject device is different than the predicate devices, the range is contained within the predicate devices, so the difference would not impact safety and effectiveness.
Note 5
The treatment time of subject device is 15 minutes, this is similarto both predicate devices and within the range outlined for predicate device II. The user can choose the frequency of treatment and discontinue treatment, so the difference of treatment time would not impact safety and effectiveness.
Note 6
Although the subject device provides 2 work modes, which are not completely the same as the predicate devices, the modes of subject device only have differences in the inflatable order of the different chambers. The treatment pressure range are the same under the different modes, so the different modes would not impact safety and effectiveness.
8. Summary for clinical test
No Clinical Test conducted.
9. Conclusion
The subject device Air Compression Leg Massager has the same intended use as the predicate devices. The few differences outlined do not affect the safety and effectiveness of the subject device when compared to the noted predicate devices. Thus, the subject device is substantially equivalent to the predicate devices.