(260 days)
Not Found
No
The description mentions a "microprocessor" and "software verification and validation testing," which are standard components of many medical devices and do not inherently indicate the presence of AI/ML. There is no mention of AI, ML, deep learning, training data, or performance metrics typically associated with AI/ML algorithms. The device's function appears to be based on a pre-programmed sequence of inflation and deflation cycles.
Yes
The device is described as an "Air Pressure Therapy System" intended to "temporarily relieve minor muscle aches and or pains, and to temporarily increase circulation to the treated areas," which are therapeutic claims.
No
The device is intended to temporarily relieve minor muscle aches and pains and temporarily increase circulation, which are therapeutic rather than diagnostic functions.
No
The device description explicitly lists hardware components such as "air pressure sensor, air pump, sleeves Etc." and describes their physical interaction ("The air pump is connected to the dedicated sleeves via a series of hoses."). The performance studies also include testing related to hardware, such as "seam strength testing" and "failure mode verification and validation testing to ensure mitigation of overpressurization risk if there is a software failure," indicating a physical device with potential hardware failures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "temporarily relieve minor muscle aches and or pains, and to temporarily increase circulation to the treated areas in people who are in good health." This describes a physical therapy or wellness device, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a system that applies air pressure to limbs. This is a mechanical action, not a process that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There is no mention of reagents, assays, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the Air Pressure Therapy System (Model:VU-IPC4M) falls under the category of a physical therapy or medical device used for external application, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Air Pressure Therapy System (Model:VU-IPCAM) 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 Pressure Therapy System (Model:VU-IPC4M) consists 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.
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)
Pants (including of upper leg, glutes, hips, lower back)
Arm (including of entire arm, shoulder)
Half-Leg (including of foot, calf, knee)
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.
Software Verification and Validation Testing:
The device also passed:
- pressure accuracy and time accuracy testing
- seam strength testing to ensure cuffs do not burst if maximum pressure is exceeded
- failure mode verification and validation testing to ensure mitigation of overpressurization risk if there is a software failure
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 logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
June 14, 2024
Xiamen Weiyou Intelligent Technology Co., Ltd. % Libray Chang Official Correspondent Shanghai Spica Management Consulting Co., Ltd. 609 Room, No. 133 Shengang Avenue, Pudong New District Shanghai, 201306 China
Re: K233238
Trade/Device Name: Air Pressure Therapy System (Model: VU-IPC4M) Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: May 23, 2024 Received: May 23, 2024
Dear Libray Chang:
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.
1
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 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).
Sincerelv.
Heather L. Dean -S
Heather Dean, Ph.D Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices
2
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) K233238
Device Name
Air Pressure Therapy System (Model: VU-IPC4M)
Indications for Use (Describe)
Air Pressure Therapy System (Model:VU-IPCAM) 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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4
| Type of Submission | Traditional |
|---|---|
| Date Prepared | June 11, 2024 |
| Submission Sponsor | |
| Manufacturer Name | Xiamen Weiyou Intelligent Technology Co., Ltd. |
| Address | Unit 3 No. 6 Xianghong Road, Torch Hi-Tech Zone |
| Industrial Park, Xiang'an District, Xiamen P.R.China. | |
| Tel | 086-0592-6251545 |
| 17916220@qq.com | |
| Contact Person | Yong Sun |
| Device Identification | |
| Trade Name | Air Pressure Therapy System (Model:VU-IPC4M) |
| Regulation Number | 21 CFR 890.5650 |
| Regulation Name | Powered inflatable tube massager |
| Device Classification | Class II |
| Product Code | IRP |
| Panel | Physical Medicine |
| Application Correspondent | |
| Company Name | Shanghai Spica Management Consulting Co., Ltd. |
| Address | 609 Room, No.133 Shengang Avenue, Pudong New District, Shanghai, China |
| Tel | 86-13020102321 |
| Libray@spicagloble.com | |
| Contact Person | Libray Chang |
| Indications for Use | |
| Air Pressure Therapy System (Model:VU-IPC4M) 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 |
Device Description
are in good health.
Air Pressure Therapy System (Model:VU-IPC4M) consists of air pressure sensor, air pump, sleeves
5
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.
Predicate and Reference Device Information
| Predicate (Primary): | THERAGUN, Inc. |
|---|---|
| Trade/Device Name | RecoveryAir PRO |
| 510(K) number | K211745 |
| Predicate (Secondary): | Wonjin Mulsan Co., Ltd. |
| Trade/Device Name | Compressible Limb and Circulation Therapy System |
| 510(K) number | K211283 |
| Predicate (Tertiary): | SLK Medical GmbH |
| Trade/Device Name | V12 PRO |
| 510(K) number | K210913 |
Performance Testing - Clinical
Not Applicable.
Performance Testing - Animal
Not Applicable.
6
Table 6A: Summary of Comparison
| | Subject Device | Primary Predicate | Secondary Predicate | Tertiary Predicate | Differences
Discussion |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | Air Pressure Therapy
System
(Model:VU-IPC4M) | RecoveryAir PRO (Model
RecoveryAir PRO) | Compressible Limb and
Circulation Therapy System | V12 PRO | N/A |
| 510(k) number | K233238 | K211745 | K211283 | K210913 | N/A |
| Manufacturer | Xiamen
Weiyou
Intelligent Technology
Co., Ltd. | Theragun Inc | Wonjin Mulsan Co., Ltd. | SLK Medical
GmbH | N/A |
| Product
regulation | 21 CFR 890.5650 | 21 CFR 890.5650 | 21 CFR 890.5650 | 21 CFR 890.5650 | Same |
| Classification
name | Massager, Powered
Inflatable Tube | Massager, Powered Inflatable
Tube | Massager, Powered Inflatable
Tube | Massager, Powered
Inflatable Tube | Same |
| Regulation class | 2 | 2 | 2 | 2 | Same |
| Product code | IRP | IRP | IRP | IRP | Same |
| Indications for
use | Air Pressure Therapy
System
(Model: VU-IPC4M) is
intended for home to
temporarily relieve
minor muscle aches
and/or pains, and to
temporarily increase | The RecoveryAir PRO is an
air compression therapy
device intended to provide
graduated pressure to
compression garments.
The RecoveryAir PRO is
indicated for the temporary
relief of minor muscle aches | POWER-Q2300 is intended
for the temporary relief of
minor muscle aches and
pains, and for temporary
increase in blood circulation
to the treated areas in people
who are in good health.
POWER-Q2300 simulates | V12 PRO is a
Compression
Therapy System is
intended for the
temporary relief of
minor muscle aches
and pains and for
the temporary | Same |
| Rx or OTC | | | | | |
| | circulation to the
treated areas in people
who are in good health. | and pains, and for temporary
increase in blood circulation
to the treated areas in people
who are in good health.
The RecoveryAir PRO
simulates kneading and
stroking of tissues by using
an inflatable garment. | kneading and stroking of
tissues by using an inflatable
garment (cuff). | increase in
circulation to the
treated areas in
people who are in
good health.
The V12 PRO
Therapy System
simulates kneading
and stroking of
tissues by using an
inflatable garment. | Same |
| Rx or OTC | OTC | OTC | OTC | OTC | Same |
| Power Source | 11.1 V / 1600mAh
Rechargeable Li-ion
battery (100-240V AC
input) | 100-240V AC, 50/60 Hz,
12V or internal battery | 110-120VAC, 50/60Hz | 110-230V 50/60 Hz | Similar |
| Dimensions
(WHL) | 25.426.036.92CM | 8.6in (L) *6.7in (W) *5.1in
(H) | 290 x 260 x 172 mm | 6.69"x 7.87"x7.87" | Similar |
| Weight | 0.58 kg | 4.202 pounds | 3.1 kg | 4.4 pounds | Similar |
| Housing
Materials | Molded ABS enclosure | Molded ABS enclosure | Molded ABS enclosure | Molded ABS
enclosure | Same |
| Number of
Chambers | 4-chamber | 4-chamber | 4 Chambers | 12 Chambers | Similar |
| Sleeve Materials | Nylon cloth +PUether
amine | Polyether Nylon Fabric | / | Nylon with a
Polyurethane
laminate | Different |
| Modes | Mode A: In this mode | Sequential, ISO or Rehab | Mode A: | Inflates chambers | Different. |
| ((Inflation
sequences)) | | (wave), Flow cycles | | | |
| | ①chamber is inflated
and the pressure is
maintained after filling;
②chambers are
inflated, chambers are
inflated and ①
chamber is deflated
while maintaining
pressure after filling;
Similarly, the pressure
is maintained after ③
chambers are filled, ④
chambers are inflated,
and ② chambers are
deflated; Then the cycle
repeats. | Sequential mode that applies
a directional massage,
starting at the base of the
treated area, and progresses
upwards towards the torso
and then releases
ISO mode that applies a
directional massage to a
smaller, user selected area.
The first chamber inflates,
and after a few seconds, the
second chamber starts to
inflate until both chambers
reach the set pressure. Then
both chambers deflate,
and after a pause the process
starts again
Wave mode: The first
chamber inflates, and after a
few seconds, the 1st and 2nd
chamber starts to inflate until
both chambers
reach the set pressure. Then | Image: Mode B | from bottom up but
maintains pressure
in lower chambers
as works its way to
top. Then all
chambers release
pressure at same
time once all
chambers have
sequentially
inflated.
Sequential | Although the
subject device
provides 7 kinds
of work mode,
the Mode A and
Mode B are the
same with
Sequential, ISO
or Rehab (wave)
of Primary
predicate device
(K211745), while
the other work
modes of 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 |
| | Mode B: In this mode,
①chamber is inflated
and the pressure is
maintained after filling;
②chamber inflation;
the same as ③chamber
and ④chamber; Then
the cycle repeats. | | Image: Mode C | | |
| | Mode C: In this mode, | | Image: Mode D | | |
7
8
9
| the four chambers are | the deflation on 1st chamber , | adversely impact | |
|---|---|---|---|
| inflated at the same | the 2nd and 3rd chambers | on safety and | |
| time, the pressure is | starts to inflate until the both | effectiveness. | |
| maintained after filling, | chambers reach the set | ||
| and then the four | pressure; then deflate the 2nd | ||
| chambers are deflated | chambers inflate 3rd and 4th | ||
| at the same time;After | chambers until the both | ||
| deflation, the four | chambers reach the set | ||
| pressure | |||
| chambers are inflated at | |||
| the same time;Then the | Flow cycles | ||
| cycle repeats. | Progress 1: first inflate | ||
| Chamber 1 to target pressure, | |||
| then hold & release. then go | |||
| to Progress 2. | |||
| Mode D: In this mode, | Progress 2: first inflated | ||
| only a single chamber | Chamber 1 to target pressure, | ||
| is inflated at a time. | theninflate Chamber 2 and | ||
| Starting from the | hold Chamber 1. when | ||
| chamber① and | Chamber 2 reach the target | ||
| working up to the | pressure, hold chamber 1 & 2 | ||
| chamber④. Then the | for specified time, then | ||
| cycle repeats. | release totally, then go to | ||
| Progress 3 | |||
| Mode E: in this mode. | Progress 3: first inflated | ||
| ①③are inflated,then | Chamber 1 to target pressure, | ||
| defalted, chamber ② | then inflate Chamber 2 and | ||
| ④are inflated,then | |||
| deflated;Then the cycle | |||
| repeats. | |||
| Mode F: in this mode. | hold Chamber 1. when | ||
| ①② are inflated, then | Chamber 2 reach the target | ||
| defalted, chamber ③ | pressure, hold chamber 1 & | ||
| ④ are inflated, then | 2, & start to inflate | ||
| deflated; Then the cycle | Chamber 3, when Chamber 3 | ||
| repeats. | reach to the target pressure, | ||
| then hold chamber 1, 2, 3 for | |||
| specified time then release | |||
| ModeG: In this mode, | totally. Then go to Progress 4 | ||
| chamber 1 inflates to | Progress 4: first inflated | ||
| set pressure, it pulses | Chamber 1 to target pressure, | ||
| and holds pressure; | then inflate Chamber 2 and | ||
| Chamber 2 inflates to | hold Chamber 1. when | ||
| set pressure, pulses and | Chamber 2 reach the target | ||
| holds pressure, | pressure, hold chamber 1 & | ||
| chamber 1 is holding | 2, & start to inflate | ||
| pressure at the same | Chamber 3, when Chamber 3 | ||
| time; Chamber 3 | reach to the target pressure, | ||
| inflates to set pressure, | then hold chamber 1, 2, 3,& | ||
| pulses and holds | start to inflate Chamber 4, | ||
| pressure, chamber 1 & | when Chamber 4 reach to the | ||
| 2 are holding pressure | target pressure, then hold | ||
| at the same time; While | chamber 1, 2, | ||
| chamber 1 is | 3 &4 for specified time then | ||
| deflating, chamber 4 | release totally. then go back | ||
| inflates to set pressure, | to Progress 1 again. | ||
| pulses and holds |
10
11
Image /page/11/Figure/3 description: The image shows different modes of operation for a compression device. The modes include sequential cycle mode, sequential rehab (wave), wave cycle mode, and ISO cycle mode. The image also shows different programs (A, B, D, E, and F) with different patterns of chamber inflation and deflation.
12
| Flow cycles | |||||
|---|---|---|---|---|---|
| Image: Flow cycle mode | |||||
| Anatomical site | Leg (including of foot, | ||||
| calf, knee, upper leg) | |||||
| Pants (including of | |||||
| upper leg, glutes, hips, | |||||
| lower back) | |||||
| Arm (including of | |||||
| entire arm, shoulder) | |||||
| Half-Leg (including of | |||||
| foot, calf, knee) | RecoveryAir Compression | ||||
| Boots: 95*28.7 cm | Leg (including of foot, calf, | ||||
| knee, upper leg) | |||||
| Hip (including of upper leg, | |||||
| glutes, hips, lower back) | |||||
| Arm (including of entire arm, | |||||
| shoulder) | |||||
| Half-Leg (including of foot, | |||||
| calf, knee) | Leg (consisting of | ||||
| foot, calf, knee, | |||||
| upper leg) Pant | |||||
| (consists of foot, | |||||
| calf, knee, upper | |||||
| leg, glutes, hips, | |||||
| lower back) | |||||
| Arm (consisting of | |||||
| entire arm, | |||||
| shoulder, upper | |||||
| chest and back) | |||||
| Jacket (consisting of | |||||
| entire arms, | |||||
| shoulder, upper | |||||
| chest and | |||||
| back) | Similar |
13
510(k) Summary K233238
Image /page/13/Figure/1 description: The image shows a comparison of different types of compression cuffs and pants. On the left, there are two sets of leg cuffs and a pair of pants, labeled with "Appearance and size of Cuffs". In the middle, there is a leg cuff with dimensions "Medium: 310x940mm" and "Large: 390x990", along with measurements of 310 and 940. On the right, there is a leg cuff with dimensions "32" x 30"", a pant, and the word "Similar".
14
Image /page/14/Figure/1 description: The image shows a collection of medical compression garments. There are pants, arm sleeves, a waist wrap, hip wraps, and a jacket. Some of the items have dimensions listed, such as the arm sleeves which are available in medium (255x870mm) and large (330x895mm).
15
| Image: black sleeve | | Half-Leg
Image: Half-Leg device with dimensions 300 and 700
300x700mm | | | |
|-----------------------|------------|-----------------------------------------------------------------------------|-------------|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Pressure range | 30~180mmHg | 20-100mmHg | 20-200 mmHg | 15-80 mmHg | Similar to
K211283,
Although the
pressure value is
different from
that of the
Primary Predicate
and Tertiary
Predicate, it is
included in the
pressure value
range of the
Secondary |
16
| | | | | | | | Predicate, so the
pressure value of
the Subject
Device can be
proven to not
affect its safety
and effectiveness |
|----------------|---------------------|------------|---------------------------|-----------------------------------------------------------|-------------------------------------------------------------------------------------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Treatment Time | Default
Settings | 30min, APP | 10min-90min, step of 5min | User can select operation
time from 15 and 30 minutes. | User determines
therapy time. Choose
from 15 to 60
minutessession
time. | | Different,
Although the
treatment time
range of subject
device is set by
APP, but the
default value is
30min which is
included in the
range of the
comparison
equipment. In the
process of use,
the user can start
or stop the button
on the hand
controller at any
time, so the
difference of
Treatment time |
17
| | | | | | would not raise
adversely impact
on safety and
effectiveness. |
|--------------------------------------------------|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Hold time within
cycle | 30-180 sec | 2-10 sec. | 1 min 20 sec | 1 min 15 sec | Similar |
| Pause interval -
between cycles | 15 sec | 10 - 70 sec | Adjustable at interval of
0/5/10/30 sec at modes A and
B
Fixed at 30 sec at modes C
and D | / | Similar |
| Mobile
application | Bluetooth
communication | Bluetooth communication | / | / | Same |
| Patient contact | Non-conductive
appliances | Non-conductive appliances | / | / | Same |
| Software/Firmw
are/Microproces
sor Control | Microprocessor | Microprocessor | / | Firmware/Micropro
cessor | Similar |
| Technology | Compressor and valve
system which
sequentially inflates
inflatable chambers | 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
cells sequentially | Same |
| Electrical safety
EMC | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11 | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11 | IEC 60601-1:2005;
IEC 60601-1-2:2014;
IEC60601-1-11:2015 | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11 | Same |
| Biocompatibility | ISO 10993-5
ISO 10993-10 | ISO 10993-5
ISO 10993-10 | ISO 10993-5
ISO 10993-10 | ISO 10993 | Same |
18
Performance Characteristic
The device meets all the applicable technical requirements of :
IEC 60601-1:2005 - Medical electrical equipments - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-11: 2015 - Medical electrical equipments for Basic Safety and Essential Performance - Collateral Standard: Requirements for medical equipment and medical electrical systems used in the home healthcare environment
IEC 60601-1-2: 2014 - Medical electrical equipments for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility
IEC 62133-2: 2017 - Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
ISO 10993-10: 2010 - Biological Evaluation of Medical Devices - Part 10: Tests for irritation and skin sensitization
ISO 10993-5:2009 - Biological Evaluation of Medical Device - Part 5: Tests for in vitro Cytotoxicity
IEEE ANSI USEMCSC C63.27-2021-American National Standard for Evaluation of Wireless Coexistence
Software Verification and Validation Testing
The device also passed:
- pressure accuracy and time accuracy testing i.
- ii. seam strength testing to ensure cuffs do not burst if maximum pressure is exceeded
- iii. failure mode verification and validation testing to ensure mitigation of overpressurization risk if there is a software failure
Conclusion
Based on the indications for use, technological characterstics, and non-clinical performance data, "Air Pressure Therapy " is as safe, as effective, and performs as well as the legally marketed predices. Therefore, the substantially equivalent to the predicate device.