(244 days)
Not Found
No
The summary describes a pneumatically controlled system using a microprocessor and sensor to control timing and pressure. There is no mention of AI, ML, or any learning or adaptive capabilities. The software is described as "moderate" level concern and V&V testing was conducted according to standard software guidance, not AI/ML specific guidance.
Yes.
The device's intended use is for "temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas," which describes a therapeutic purpose.
No
The device is described as an "Air Compression Therapy Recovery System" used for "temporary relief of minor muscle aches and pains and for temporary increase in circulation." It simulates tissue kneading and stroking. There is no mention of it being used for diagnosis or detecting medical conditions.
No
The device description explicitly states it consists of a control unit, air boots, arm sleeves, and pants, which are physical hardware components. It also mentions an electronically controlled air pump and air valve. While software controls the timing and pressure, the device is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for "temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas." This describes a physical therapy or recovery 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 system that uses air compression to simulate kneading and stroking of body parts. This is a mechanical action applied externally to the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to in vitro examination.
- Performance Studies: The performance studies focus on safety (electrical, electromagnetic, biocompatibility) and software validation, which are typical for medical devices but not specifically for IVDs. There are no studies related to diagnostic accuracy, sensitivity, specificity, etc., which are key metrics for IVDs.
In summary, the Air Compression Therapy Recovery System is a physical therapy/recovery device that applies external compression to the body. It does not perform any in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Air Compression Therapy Recovery System (model: MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401) is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas. The Air Compression Therapy Recovery System simulates kneading and stroking of tissues by using an inflatable garment. This device is Over-The-Counter (OTC). It is intended for use by healthy adults who are over 21 years old.
Product codes
IRP
Device Description
The Air Compression Therapy Recovery System (model: MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401) is a portable inflatable tube massage system which simulates kneading and stroking of leg, arm and hip by the use of inflatable air compression techniques. The device can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains. This device is Over-The-Counter (OTC). It is intended for use by healthy adults who are over 21 years old.
The device utilizes the pneumatically controlled chambers actuated by an electronically controlled air pump and air valve. The pump, air valve and other components are protectively housed within the ABS plastic enclosure of the control unit.
The device consists of a control unit, two RecoveryLeg (air boot with attached hose connector), two RecoveryArm (air arm sleeve with attached hose connector) and one RecoveryPants (air pants with two attached hoses and hose connectors). The RecoveryLeg, RecoveryArm and RecoveryPants work under the action of sensor and microprocessor. Software controls the timing and pressure reflected by the sensor, cycling airflow into and out of the boots, sleeves or pants to compress body.
The device is categorized to have long-term skin contact of greater than 30 days.
Environment of use of the device: Clinics, hospital, athlete training, and home environments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Leg (including of foot, calf, knee, upper leg) Hip (including of upper leg, glutes, hips, lower back) Arm (including of entire arm, shoulder, upper chest and back)
Indicated Patient Age Range
healthy adults who are over 21 years old.
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)
Non-Clinical Performance Testing:
- General requirements for basic safety and essential performance (IEC 60601-1:2005/AMD1:2012/AMD2:2020) - Pass
- Electromagnetic disturbances (IEC 60601-1-2:2014+A1:2020) - Pass
- Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015/AMD1:2020) - Pass
- Biocompatibility testing (ISO 10993-1: 2018, ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-23: 2021)
- Software verification and validation testing: Software considered a "moderate" level concern.
Clinical Performance:
Clinical testing was not needed for this 510(k).
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
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 logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
October 26, 2023
Jiangsu MaxF Electric Appliance Co., Ltd % Cassie Lee Official Correspondent Share Info (Guangzhou) Medical Consultant Ltd No. 1919-1920, Building D3, Minjie Plaza Shuixi Road, Huangpu District Guangzhou, Guangdong 510000 China
Re: K230500
Trade/Device Name: Air Compression Therapy Recovery System (model: MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401) Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: August 10, 2023 Received: August 11, 2023
Dear Cassie Lee:
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
1
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).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
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 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 L. Dean -S
Heather Dean, PhD
2
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) K230500
Device Name
Air Compression Therapy Recovery System (model: MF-AWI.LED.A-801. MF-AWI.LED.B-801. MF-AWI.OLED.A-601. MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401)
Indications for Use (Describe)
The Air Compression Therapy Recovery System (model: MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-A WI.LED.B-401) is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas. The Air Compression Therapy Recovery System simulates kneading of tissues by using an inflatable garment. This device is Over-The-Counter (OTC). It is intended for use by healthy adults who are over 21 years old.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
510(k) Summary K230500
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
Name: Jiangsu MaxF Electric Appliance Co., Ltd Establishment Registration Number: 3017153262 Address: NO.12, West Park Road, Rulin Town, Jintan District, Changzhou, China
Contact name: ZHANG JIANFANG Tel: +86-15961228139 E-mail: 372601574@qq.com Postal Code: 213200
Application Correspondent:
Name: Share Info (Guangzhou) Medical Consultant Ltd. Contact Person: Ms. Cassie Lee Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: +86 20 8266 2446 Email: regulatory@share-info.com
2. Date of the summary prepared: October 25, 2023
3. Subject Device Information
Classification Name: Massager, powered inflatable tube Trade Name: Air Compression Therapy Recovery System Model Name: MF-AWI, MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401 Review Panel: Physical Medicine Product Code: IRP Regulation Number: 890.5650 Regulatory Class: II
4. Predicate Device Information
5
Predicate Device 1 Information
Sponsor: Rapid Reboot Recovery Products, LLC Trade Name: Rapid Reboot Compression Therapy System Classification Name: Massager, powered inflatable tube 510(K) Number: K182668 Review Panel: Physical Medicine Product Code: IRP Regulation Number: 890.5650 Regulation Class: II
Predicate Device 2 Information
Sponsor: FOSHAN HONGFENG CO.,LTD. Trade Name: Air compression therapy system Classification Name: Massager, powered inflatable tube 510(K) Number: K201982 Review Panel: Physical Medicine Product Code: IRP Regulation Number: 890.5650 Regulation Class: II
5. Device Description
The Air Compression Therapy Recovery System (model: MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401) is a portable inflatable tube massage system which simulates kneading and stroking of leg, arm and hip by the use of inflatable air compression techniques. The device can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains. This device is Over-The-Counter (OTC). It is intended for use by healthy adults who are over 21 years old.
The device utilizes the pneumatically controlled chambers actuated by an electronically controlled air pump and air valve. The pump, air valve and other components are protectively housed within the ABS plastic enclosure of the control unit.
The device consists of a control unit, two RecoveryLeg (air boot with attached hose connector), two RecoveryArm (air arm sleeve with attached hose connector) and one RecoveryPants (air pants with two attached hoses and hose connectors). The RecoveryLeg, RecoveryArm and RecoveryPants work under the action of sensor and microprocessor. Software controls the timing and pressure reflected by the sensor, cycling airflow into and out of the boots, sleeves or pants to compress body.
The device is categorized to have long-term skin contact of greater than 30 days.
Environment of use of the device: Clinics, hospital, athlete training, and home environments.
6
6. Intended Use / Indications for Use
The Air Compression Therapy Recovery System (model: MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401) is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas. The Air Compression Therapy Recovery System simulates kneading and stroking of tissues by using an inflatable garment. This device is Over-The-Counter (OTC). It is intended for use by healthy adults who are over 21 years old.
7. Comparison to predicate device and conclusion
As compared to the predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between subject device and predicate device do not raise any new questions of safety or effectiveness.
| Elements of
Comparison | Subject Device | Predicate Device
(Primary) | Predicate Device
(Secondary) | Remark |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|-------------------|
| Company | Jiangsu MaxF Electric
Appliance Co., Ltd | Rapid Reboot
Recovery
Products, LLC | FOSHAN HONGFENG
CO.,LTD. | -- |
| Trade Name | Air Compression Therapy
Recovery System (model:
MF-AWI, MF-AWI.LED.A-
801,
MF-AWI.LED.B-801,
MF-AWI.OLED.A-601,MF-
AWI.LED.A-601,MF-
AWI.LED.B-601, MF-
AWI.OLED.A-401,MF-
AWI.LED.A-401,MF-
AWI.LED.B-401) | Rapid Reboot
Compression
Therapy System | Air compression
therapy system: FO-
3001 | -- |
| Classification
Name | Massager, Powered
inflatable tube | Massager, powered
inflatable tube | Massager, powered
inflatable tube | Same |
| 510(k)
Number | K230500 | K182668 | K201982 | -- |
| Product Code | IRP | IRP | IRP | -- |
| Regulation
Number | 890.5650 | 890.5650 | 890.5650 | Same |
| FDA Device
Classification | II | II | II | Same |
| Review Panel | Physical Medicine | Physical Medicine | Physical Medicine | Same |
| Rx or OTC | OTC | OTC | OTC | Same |
| Intended Use /
Indications for | The Air Compression
Therapy Recovery | The Rapid Reboot
Compression | Intended for home to
temporarily relieve | Same |
| Elements of
Comparison | Subject Device | Predicate Device
(Primary) | Predicate Device
(Secondary) | Remark |
| Use | System (model: MF-AWI,
MF-AWI.LED.A-801, MF-
AWI.LED.B-801, MF-
AWI.OLED.A-601, MF-
AWI.LED.A-601, MF-
AWI.LED.B-601, MF-
AWI.OLED.A-401, MF-
AWI.LED.A-401, MF-
AWI.LED.B-401) is
indicated for the
temporary relief of minor
muscle aches and pains
and for temporary
increase in circulation to
the treated areas. The Air
Compression Therapy
Recovery System
simulates kneading and
stroking of tissues by
using an inflatable
garment. This device is
Over-The-Counter (OTC).
It is intended for use by
healthy adults who are
over 21 years old. | Therapy System is
intended for the
temporary relief of
minor muscle
aches and pains
and for the
temporary increase
in circulation to the
treated areas in
people who are in
good health. The
Rapid Reboot
Compression
Therapy System
simulates kneading
and stroking of
tissues by using an
inflatable garment. | minor muscle aches
and/or pains, promote
blood circulation in
treated areas. | |
| Treatment
time | 0-50mins | User determines
therapy time.
Choose from 10,
20, or 30 minute
session time, with
option to add
additional 10
minutes to any
therapy time. | 1-60mins | Similar
Note 1 |
| Treatment
area | Leg (including of foot, calf,
knee, upper leg)
Hip (including of upper
leg, glutes, hips, lower
back)
Arm (including of entire
arm, shoulder, upper
chest and back) | Leg (including of
foot, calf, knee,
upper leg)
Hip (including of
upper leg, glutes,
hips, lower back)
Arm (including of
entire arm,
shoulder, upper
chest and back) | Leg | Same |
| Environment | Clinics, hospital, athlete | Clinics, hospital, | Not provided in the | Same |
7
8
9
| Elements of
Comparison | Subject Device | Predicate Device
(Primary) | Predicate Device
(Secondary) | Remark |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| | chambers one and two
are fully inflated, the third
and the fourth chamber
begin to inflate while the
first and the second
chambers begin to
deflate. The cycle repeats
through the 8 chambers.
Image: chambers | | for chamber ③④ till
chamber ⑤⑥, pause
for 3 seconds. Then
repeat. D (Whole
Squeeze Mode):
chamber ①②③④⑤⑥
inflating at the same
time till setup pressure
or for 90 seconds, then
deflating in the same
time for 3 seconds.
Then repeat. E
(Combined B + C):
sequential squeeze +
double wave F
(Combined A + C + D):
normal + double wave
- whole squeeze. 4
and 8 chambers same
as 6 chambers above. | |
| | Mode D: Pressure fills
two chambers at a time
until all 8 are filled. The
first and the second
chambers inflate to the
selected pressure. Once
fully inflated, the third and
the fourth chambers begin
to inflate until all 8
chambers are fully
inflated. Then, all the 8
chambers deflate together
and the cycle repeats.
Image: chambers | | Image: chambers | |
| | Mode E: Pressure fills
one chamber at a time
and that chamber
deflates while next
chamber fills. When the
first chamber inflates to
the selected pressure, the
third chamber begins to
inflate and the first
chamber deflates. When
the third chamber fully
inflates, the fifth chamber
begins to inflate and the
third chamber deflates.
Then the seventh,
second, fourth, sixth and
eighth inflate and deflate
one by one | | | |
10
| Elements of
Comparison | Subject Device | Predicate Device
(Primary) | Predicate Device
(Secondary) | Remark |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------|-------------------|
| | Image: [Subject Device Image]
For MF-AWI.OLED.A-601
and MF-AWI.OLED.A-401
using 6 chambers and 4
chambers, the mode is
the same as mode of MF-
AWI as demonstrated
above.
For
MF-AWI.LED.B-801,MF-
AWI.OLED.A-601,MF-
AWI.LED.A-601,MF-
AWI.LED.B-601, MF-
AWI.LED.A-401,MF-
AWI.LED.B-401
They only has one mode
(mode B). | | | |
| Output
pressure
range | 0-40-80-120-160-
200mmHg
(Tolerance: -10% ~
+20%) | 0-200 mmHg | 30-110mmHg | Similar
Note 1 |
| Power source | 100-240V, 50/60Hz | 110VAC, 60Hz | 100-127V/220-240V,
50/60Hz | Similar
Note 3 |
| Power | 30W | 30W | 65 W | Same |
| Number of
Chamber | 4, 6, 8 | 4 | 4, 6, 8 | Same |
| Photo/size of
the control
unit | Image: [Subject Device Photo] | Image: [Predicate Device (Primary) Photo]
10" x 6.5" x 5" | Image: [Predicate Device (Secondary) Photo]
220190113mm | Similar
Note 4 |
11
| Elements of
Comparison | Subject Device | Predicate Device
(Primary) | Predicate Device
(Secondary) | Remark |
|------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-------------------|
| | Image: Subject Device Top
Image: Subject Device Bottom
140mm x 87mm x 280mm | | | |
| Housing
materials | Molded ABS enclosure | Molded ABS enclosure | Molded ABS enclosure | Same |
| Compression
Applicator
Garments
Boots/Sleeves
/pants
Material | TPU Nylon Composite | Nylon with a
Polyurethane
laminate | Not mentioned in the
510k summary | Similar
Note 5 |
| Photo/size of
the boots | Image: Subject Device Boots
1060mm x 345mm | Image: Predicate Device Primary Boots
X-Short: 14" x 41"
Short: 14" x 43"
Medium: 14" x 45"
Long: 14" x 48"
X-Long: 14" x 52"
Image: Predicate Device Primary Boot Size | Image: Predicate Device Secondary Boots
M:9165cm
L:10074cm
XL:110*70cm
(Overlapping) | Similar
Note 4 |
12
| Elements of
Comparison | Subject Device | Predicate Device
(Primary) | Predicate Device
(Secondary) | Remark |
|---------------------------------------------------|-------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-------------------|
| Photo/size of
the arm
sleeves | Image: Subject Device arm sleeves
974mm x 325mm | Image: Predicate Device (Primary) arm sleeves
Regular: 18" x 38"
Long: 18" x 44" | No arm sleeves | Similar
Note 4 |
| Photo/size of
the pants | Image: Subject Device pants
530mm x 730mm | Image: Predicate Device (Primary) pants
Regular:
26" x 32"
Large: 26"
35" | No pants | Similar
Note 4 |
| Safety feature | Button on control unit
allow users to stop or
pause therapy session at
any time. | Button on display
allows users to stop
or pause therapy
session at any time. | Power button on main
unit allows user to stop
therapy session at any
time | Same |
| Mode of
compression | Sequential | Sequential | Sequential | Same |
| Software/firm
ware/micropro
cess or control | Microprocessor | Microprocessor | Microprocessor | Same |
| Technology | Compressor and valve
system which sequentially
inflates cells of appliance. | Compressor and
valve
system which
sequentially
inflates cells of
appliance. | Compressor and valve
system which
sequentially inflates
inflatable chambers | Same |
| Electrical | ANSI-AAMI ES 60601-1 | ANSI-AAMI ES | IEC 60601-1 | Same |
13
| Elements of
Comparison | Subject Device | Predicate Device
(Primary) | Predicate Device
(Secondary) | Remark |
|---------------------------------------|----------------|-------------------------------|---------------------------------|--------|
| safety, EMC,
Bio-
compatibility | IEC 60601-1-2 | 60601-1 | IEC 60601-1-2 | |
| | IEC 60601-1-11 | IEC 60601-1-2 | IEC 60601-1-11 | |
| | ISO 10993-5 | IEC 60601-1-11 | ISO 10993-10 | |
| | ISO 10993-10 | ISO 10993-5 | ISO 10993-5 | |
| | ISO 10993-23 | ISO 10993-10 | ISO 10993-12 | |
Comparison in Detail(s):
Note 1:
Though there is a little difference of "treatment time" and "output pressure range" between the subject device and predicate devices, but treatment time is within the time range of predicate device 2, and output pressure range is within the predicate device 1. So, this slight difference will not raise any safety and effectiveness issue.
Note 2:
The mode A, B, C of subject device is similar to the Normal Mode, Sequential Squeeze Mode and Double Wave mode of predicate device 1 respectively. The inflating and deflating order of mode D, and E is different from predicate devices, but will not raise any safety and effectiveness issue.
Note 3:
Though there is difference of "power source" between the subject device and predicate device, but the subject device has been tested per ANSI/AAMI ES60601-1, IEC 60601-1-11. So, the difference of modes would not adversely impact safety and effectiveness.
Note 4:
Though there is difference of "Photo/size of the control unit", "Photo/size of the boots", "Photo/size of the arm sleeves", "Photo/size of the pants sleeves" between subject device and predicate devices 1, but the difference would not adversely impact safety and effectiveness.
Note 5:
Though there is difference in material of boots/sleeves/pants does not contact with skin during the massage, and the TPU Nylon Composite has been tested per ISO 10993-10 and ISO 10993-23, so the difference would not adversely impact safety and effectiveness.
8. Test Summary
8.1 Summary of Non-Clinical Performance Testing
1) Performance Testing Summary
The Air Compression Therapy Recovery System (model: MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401) has been evaluated the safety and performance by lab bench testing as following:
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| Title of the test | Device
Description
/Sample
Size | Test
Method/Ap
plicable
Standards | Acceptance
criteria | Unexpec
ted
Results/
Significa
nt
Deviatio
ns | Test
results |
|--------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|-----------------|
| General
requirements for
basic safety and
essential
performance | The test
sample is
the final,
finished
product. | IEC 60601-
1:2005/AMD
1:2012/AMD
2:2020 | The test is
carried out
under the test
method
specified in the
standard, and
the test result is
within the test
acceptance
range of the
standard. | NA | Pass |
| Electromagnetic
disturbances | The
test
sample
is
the
final,
finished
product. | IEC 60601-
1-
2:2014+A1:
2020 | No degradation
of performance
was
found
during
test or
Lower
than
limits
of
measurement | NA | Pass |
| Requirements
for medical
electrical
equipment and
medical
electrical
systems used in
the home
healthcare
environment. | The
test
sample
is
the
final,
finished
product. | IEC 60601-
1-
11:2015/AM
D1:2020 | The
device
operates
normally, and
can
provide
basic
safety
and
essential
performance. | NA | Pass |
Biocompatibility testing 2)
- . ISO 10993-1: 2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management.
- . ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
- . ISO 10993-10:2021Biological Evaluation of Medical Devices - Part 10: Tests skin sensitization
- . ISO 10993-23: 2021 Biological Evaluation of Medical Devices - Part 23: Test for irritation
3) Software verification and validation testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA'S Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as
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a "moderate" level concern, since a malfunction of, or a latent design flaw in, the Software Device leads to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.
4) Cybersecurity
The subject device no any external interfaces, according to FDA guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", no need cybersecurity evaluation.
8.2 Clinical Performance
Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively.
9. Final Conclusion:
The subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices K182668 and K201982.