(238 days)
No
The description focuses on pneumatic control, electronic components, and user interface buttons, with no mention of AI/ML algorithms for controlling the massage patterns or adapting to user needs.
Yes
The device is indicated for "temporary relief of minor muscle aches and pains" and "temporary increase in circulation," which are therapeutic claims.
No
The device is indicated for temporary relief of minor muscle aches and pains and temporary increase in circulation, not for diagnosing medical conditions.
No
The device description clearly outlines physical components such as an air pump unit, battery, control components housed in a plastic case, function buttons, LED indicators, a charging port, leg wraps with air hoses and air bladders, and mentions warming and vibration features. These are all hardware components, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for temporary relief of minor muscle aches and pains and temporary increase in circulation. This is a physical therapy/massage function, not a diagnostic test performed on samples from the body.
- Device Description: The device description details a system that applies air pressure to the legs to simulate massage. This is a physical intervention, not a diagnostic process.
- No mention of biological samples: There is no indication that this device interacts with or analyzes biological samples (like blood, urine, tissue, etc.), which is a core characteristic of IVD devices.
- Performance Studies: The performance studies listed are related to biocompatibility, electrical safety, battery safety, and software validation. These are typical for medical devices that interact physically with the body, not for diagnostic devices.
In summary, the Air Compression Leg Massager is a therapeutic device that applies physical pressure to the body, not a diagnostic device that analyzes biological samples.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
IRP, IRO
Device Description
Air Compression Leg Massager is a portable and rechargeable device. It is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading of tissue with the hards by use of inflatable presure 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 by an electronically controlled air pump unit. A pump, battery and control components are protectively housed in a plastic case of Controller.
Function buttons and light emitting diode (LED) indicators on the user interface. There is a charging port at the bottom of Controller for connecting the alternating current (AC) adapter plug.
Each leg wap has an air hose for connection to Controller, and both encase a 2-chamber air bladder inside. It can be wrapped and massaged separately by the two chambers. The soft medical fabric of wraps provides patient comfort and biocompatibility compliance.
Air Compression Leg Massager is also capable of providing the warming and vibration, these are included for an improved user experience.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Leg (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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data were provided in support of the substantial equivalence determination.
- Biocompatibility Testing
The biocompatibility evaluation for the body-contacting components of the subject device was conducted in accordance with the "Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Nanagement Process", as recognized by FDA. The following testing was performed to, and passed, including:
- ISO 10993-5, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10, Biological evaluation of medical devices Part 10: Tests for skin sensitization
- ISO 10993-23, Biological evaluation of medical devices Part 23: Tests for skin irritation
- Electrical Safety and EMC
Electrical safety and EMC testing was performed to, and passed, the following standards:
- IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2 Medical electrical equipments Part 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-11 Medical Electrical Equipment Part 1: 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
- Battery Safety
- IEC 62133-2 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
- Software Verification and Validation
Software documentation consistent with basic documentation this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
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.
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 17, 2025
Jiale Health Technology Shenzhen Co., Ltd. % Youshan Gong RA Specialist Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Qianhai Road Shenzhen, Guangdong 518052 China
Re: K242140
Trade/Device Name: Air Compression Leg Massager (K-705) Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP, IRO Dated: January 15, 2025 Received: February 26, 2025
Dear Youshan Gong:
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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
2
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 Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
| Indications for Use | |
|---|---|
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K242140 |
| ? | |
| Please provide the device trade name(s). | |
| Air Compression Leg Massager (K-705) | |
| ? | |
| Please provide your Indications for Use below. | |
| 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. | |
| ? | |
| Please select the types of uses (select one or both, as applicable). | Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) | |
| ? |
4
510(k) Summary K242140
"510(k) Summary" as required by 21 CFR Part 807.92.
Date Prepared: 2025-3-11
I. Submitter
Jiale Health Technology Shenzhen Co., Ltd. 201, Builing A, No, 17, Guangjin Road, Shapu Community, Songgang Street, Bao 'an District, Shenzhen, China Post code: 518100 Tel.: 0755-27085534
XieLixun General Manager Tel: +86-13823109212 E-mail: 402952497@qq.com
II. Device
Name of Device: Air Compression Leg Massager Model(s): K-705 Common or Usual Name: Massager, Powered Inflatable Tube Regulation Name: Powered inflatable tube massager Regulatory Class: II Product Code: IRP, IRO Regulation Number: 21 CFR 890.5650, 21 CFR 890.5975
III. Predicate Device and Reference Device
- Predicate Device A
5
| Manufacturer | Predicate Device | 510(k) Number |
|---|---|---|
| Xiamen Emoka | ||
| HealthScience& | ||
| Technology Co., Ltd. | Air Compression Leg | |
| Massager (model: EMK-701) | K222991 |
Secondary Predicate Device A
| Manufacturer | Reference Device | 510(k) Number |
|---|---|---|
| THERABODY, Inc | JetBoots PRO Plus | K241256 |
IV. Device Description
Air Compression Leg Massager is a portable and rechargeable device. It is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading of tissue with the hards by use of inflatable presure 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 by an electronically controlled air pump unit. A pump, battery and control components are protectively housed in a plastic case of Controller.
Function buttons and light emitting diode (LED) indicators on the user interface. There is a charging port at the bottom of Controller for connecting the alternating current (AC) adapter plug.
Each leg wap has an air hose for connection to Controller, and both encase a 2-chamber air bladder inside. It can be wrapped and massaged separately by the two chambers. The soft medical fabric of wraps provides patient comfort and biocompatibility compliance.
Air Compression Leg Massager is also capable of providing the warming and vibration, these are included for an improved user experience.
V. Indications for Use
6
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 of tissues by using an inflatable garment.
VI. Materials
| Model | Contacted Component Name | Materials |
|---|---|---|
| K-705 | Leg wraps | Nylon polyester |
| Enclosure of Controller | ABS, PC |
VII. Comparison of Technological Characteristics With the Predicate Device
The Air Compression Leg Massager (K-705) has the same intended use as the predicate devices . The technological characteristics such as application area, number of chambers, ar pressure level and treatment time, are similar to the primary predicate device. Any minor differences between the listed primary predicate device and secondary predicate device do no raise any issues of safety or efficacy. Performance data supports that the device is the primary predicate device and secondary predicate device for its intended use.
Therefore, the Air Compression Leg Massager may be found substantially equivalent to its primary predicate device.
| Comparison Elements | Subject Device | Primary Predicate Device | Secondary Predicate Device | Remark |
|---|---|---|---|---|
| Model | K-705 | EMK-701 | JetBoots PRO Plus | / |
| 510(k) Number | K242140 | K222991 | K241256 | / |
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| Comparison Elements | Subject Device | Primary Predicate Device | Secondary Predicate Device | Remark |
|---|---|---|---|---|
| Model | K-705 | EMK-701 | JetBoots PRO Plus | / |
| Trade name | Air Compression Leg | |||
| Massager | Air Compression Leg | |||
| Massager (model: EMK- |
-
| JetBoots PRO Plus | / |
| Manufacturer | Jiale Health Technology
Shenzhen Co., Ltd. | Xiamen Emoka
HealthScience&
Technology Co., Ltd. | THERABODY, Inc | / |
| Regulation number | 21 CFR 890.5650
21 CFR 890.5975 | 21 CFR 890.5650
21 CFR 890.5975 | 21 CFR 890.5650
21 CFR 890.5500
21 CFR 890.5975 | Same |
| Device class | II | II | II | Same |
| Product code | IRP, IRO | IRP | IRP, ILY, IRO | Same |
| Comparison Elements | Subject Device | Primary Predicate Device | Secondary Predicate Device | Remark |
| Model | K-705 | EMK-701 | JetBoots PRO Plus | / |
| Indication 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. | 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. | JetBoots PRO Plus is an air
compression therapy device
intended to provide graduated
pressure to the legs. JetBoots PRO
Plus is indicated for the temporary
relief of minor muscle aches and
pains, and for a temporary increase
in blood circulation to the treated
area in people who are in good
health. JetBoots PRO Plus
simulates kneading and stroking of
tissues by using an inflatable
garment. | Same |
| Prescription or OTC | Over-The-Counter Use | Over-The-Counter Use | Over-The-Counter Use | Same |
| Power Source | Input: AC100-240V,50/60HZ
Output: DC5V/1A
Internal battery: 3.7V
2500mAh | Input: AC100-240V,
50/60Hz
Output: DC 13.5V, 1A
Internal battery:
11.1V,1000mAh | Power Adapter:
AC Input: 100 -240V AC,
50/60Hz, DC Output: 15.0V, 4.8A,
72W
Or
Internal Battery | Different |
| Comparison Elements | Subject Device | Primary Predicate Device | Secondary Predicate Device | Remark |
| Model | K-705 | EMK-701 | JetBoots PRO Plus | / |
| Power
consumption | 6.5W | 13.5 W | 72W
Or
Internal Battery | Different |
| Dimensions (WHD) | 35817267mm | 2155070 mm | Console & Compression boot (Lead
or Support, deflated and fully
extended):
• S-size: 36.8in (L) * 5.3in (W) *
14.8 (H)
• M-size: 42.9in (L) * 5.3in (W) *
16.1 (H)
• L-size: 46.5in (L) * 5.3in (W) *
16.1 (H) | Different |
| Weight | 0.59kg(1.28pounds) | 2.0 Kg (4.4pounds) | S-size: 6.0lb (per boot)
M-size: 6.4lb (per boot)
L-size: 6.7lb (per boot) | Different |
| Housing
Materials | Molded ABS enclosure | Molded ABS enclosure | Molded PC+ABS enclosure | Same |
| Comparison Elements | Subject Device | Primary Predicate Device | Secondary Predicate Device | Remark |
| Model | K-705 | EMK-701 | JetBoots PRO Plus | / |
| Sleeves Dimensions | Leg Wrap: 350628mm | Leg Wrap: 730468 mm | Compression boots sleeves attached to consoles.
Sleeves (extended) only:
S: 80cm (L)* 37.5 cm (H)
M: 95cm (L)* 41.0 cm (H)
L: 1050cm (L)* 41.0 cm (H) | Different |
| Application area | Leg (calves) | Leg (feet, calves) | Leg (feet, calve) | Different |
| Number of Chambers | 2-chamber | 2-chamber | 4-chamber | Different |
| Sleeve Materials | Nylon polyester | Dacron | Polyether Nylon Fabric | Different |
| Mode of Compression | Sequential | Sequential | No related information | Same |
| Comparison Elements | Subject Device | Primary Predicate Device | Secondary Predicate Device | Remark |
| Model | K-705 | EMK-701 | JetBoots PRO Plus | / |
| Air Pressure
Level | Low level: 120mmHg
Medium level: 170mmHg
High level: 210mmHg
Error range: ±25mmHg | Low level: 120mmHg
Medium level: 170mmHg
High level: 210mmHg
Error range: ±25mmHg | 20 – 100 mmHg, steps of 5mm Hg | Same |
| Treatment Time | 15 minutes | 15 minutes | 10min – 60min, steps of 5min for
Pneumatic Compression
10min – 45min for Infrared LED | Same |
| Inflation time | 2-12s | 5 -18 s | No related information | Different |
| Keep time | 3-6s | 2 - 5 s | 0 – 10 seconds depending on the
selected preset. | |
| Deflation time | 1-6s | 2 - 5 s | No related information | |
| Comparison Elements | Subject Device | Primary Predicate Device | Secondary Predicate Device | Remark |
| Model | K-705 | EMK-701 | JetBoots PRO Plus | / |
| Cycle time | Range of 6sec to 1 min 2.0sec | Range of 26 sec to 1 min 29
sec | Pause interval between cycles: 15
seconds | |
| Work Mode | The model is divided into
three processes.
Mode 1: The upper leg air
bag is pressurized, then the
lower air bag is pressurized,
and then the pressure is
relieved, and then the above
process is repeated. Then the
upper and lower is pressurized
at the same time, and then the
static pressure is maintained.
And then the cycle is
repeated.
The air pressure of Mode 1 is
120mmHg. | Mode 1:
The model is divided into
three processes. The first
process is starting w ith 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 is compressed.
Then calf chamber deflates,
and finally foot chamber
deflates. The third process is
starting with calf chamber | Sequential, ISO, or Static Flow
Cycles
Sequential mode that applies a
directional massage, starting at the
base of the
treated area, and progresses
upwards towards the torso and then
releases.
Image: Sequential cycle mode | Different |
| Comparison Elements | Subject Device | Primary Predicate Device | Secondary Predicate Device | Remark |
| Model | K-705 | EMK-701 | JetBoots PRO Plus | / |
| | Image: foot diagram
Image: foot diagram
Mode 2: The lower air bag is
pressurized→ pressure
retention → pressure→
pressure retention →pressure
relief. And then the cycle is
repeated.
The air pressure of Mode 2 is
170mmHg.
Image: foot diagram
Image: foot diagram
Mode 3: The upper and lower
pressure is pressurized at the
same time →The upper
pressure → pressure relief.
And then the cycle is
repeated. | Mode 1 follow s 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 follow s this
pressure sequence: Foot +
Calf → Interval → Foot+
Calf
The inflating and deflating
time are different according
to the intensity selected. | 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.
Image: ISD cycle mode diagram
Flow cycles Progress 1: first inflate
Chamber 1 to target pressure, then
hold &
release, then go to Progress 2. | |
| Comparison Elements | Subject Device | Primary Predicate Device | Secondary Predicate Device | Remark |
| Model | K-705 | EMK-701 | JetBoots PRO Plus | / |
| | The air pressure of Mode 3 is
210mmHg.
Image: diagram of air pressure | | Progress 2: first inflated Chamber 1
to target pressure, then inflate
Chamber 2 and hold Chamber 1.
when Chamber 2 reach the target
pressure, hold chamber 1 & 2 for
specified time, then release totally,
then go to Progress 3 Progress 3:
first inflated Chamber 1 to target
pressure, then inflate Chamber 2
and hold Chamber 1. when
Chamber 2 reach the target
pressure, hold chamber 1 & 2, &
start to inflate Chamber 3, when
Chamber 3 reach to the target
pressure, then hold chamber 1, 2, 3
for specified time then release
totally. then go to Progress
4.Progress 4: first inflated Chamber
1 to
target pressure, then inflate
Chamber 2 and hold Chamber 1.
when Chamber 2
reach the target pressure, hold
| |
| Comparison Elements | Subject Device | Primary Predicate Device | Secondary Predicate Device | Remark |
| Model | K-705 | EMK-701 | JetBoots PRO Plus | / |
| | | | Chamber 3, when Chamber 3 reach
to the target pressure, then hold
chamber 1, 2, 3,& start to inflate
Chamber 4, when Chamber 4 reach
to the target pressure, then hold
chamber 1, 2, 3 &4 for specified
time then release totally. then go
back to Progress 1 again.
Image: Static Cycle diagram
Static Cycle
The chambers inflate one at the
time starting at chamber 1 while
maintaining
negative gradient of compression
along the leg. The pressure is
limited to 20
mmHg to 30 mmHg. Once inflated,
the chambers do not deflate during | |
| Comparison Elements | Subiect Device | Primary Predicate Device | Secondary Predicate Device | Remark |
| Model | K-705 | EMK-701 | JetBoots PRO Plus | / |
| | | | the
treatment. While the garment is
inflated, it comes in contact with
the legs to optimize the treatment of
vibration and infrared LED light by
ensuring optimal contact with the
leg. | |
| Noise level | ≤ 65 dB | ≤ 65 dB | No related information | Same |
| Patient contact | Non-conductive appliances | Non-conductive appliances | Non-conductive appliances | Same |
| Softw are/Firmware/
Microprocessor
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 cells of
appliance,
Light Emitting Diodes | Same |
| Safety Features | Power button allows user to
stop therapy session at any
time | Power button allows user to
stop therapy session at any
time | No related information | Same |
| Comparison Elements | Subiect Device | Primary Predicate Device | Secondary Predicate Device | Remark |
| Model | K-705 | EMK-701 | JetBoots PRO Plus | / |
| Operating
environment | Temperature: 5°C-35°C
Humidity: 5%- 90% non-
condensing
Atmospheric Pressure: 75-
106kPa | Temperature: 5°C-40°C
Humidity: 5%- 90% non
condensing | No related information | Same |
| Transportation &
Storage
environment | Temperature: -20°C55°C55°C
Humidity: 5%-90% non
condensing
Atmospheric Pressure: 75-
106kPa | Temperature: -20°C
Humidity: 5%-90% non
condensing
Atmospheric Pressure: 75-
106kPa | No related information | Same |
| Level of heating | Low temperature: 35°C
Medium temperature: 38°C
High temperature: 41°C
Error range: ±2°C | N/A | Maximum Device Surface
Temperature: 43.2°C
Highest Measured Skin
Temperature During Treatment:
36.8° C | Different |
| Level of vibration
frequency | Constant frequency
150Hz(±15Hz)
Low level: 1 second on, 3
seconds off
Mid level: 1 second on, 2 | N/A | No related information | Different |
| Comparison Elements | Subject Device | Primary Predicate Device | Secondary Predicate Device | Remark |
| Model | K-705 | EMK-701 | JetBoots PRO Plus | / |
| | seconds off
High level: 0.5 second on, 0.5
seconds off | | | |
| Electrical safety, EMC | IEC 60601-1
IEC 60601-1-2
IEC 62133-2
IEC 60601-1-11 | ANSI/AAMI ES60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 61233 | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11 | Same |
| Biocompatibility | ISO 10993-5
ISO 10993-10
ISO 10993-23 | ISO 10993-5 ISO 10993-10 | ISO 10993-5
ISO 10993-10 | Same |
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12
13
14
15
16
17
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Conclusions
Air Compression Leg Massage is substantially equivalent to the primary predicate device and secondary predicate device.
VIII. Performance Data
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The following performance data were provided in support of the substantial equivalence determination.
1) Biocompatibility Testing
The biocompatibility evaluation for the body-contacting components of the subject device was conducted in accordance with the "Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Nanagement Process", as recognized by FDA. The following testing was performed to, and passed, including:
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ISO 10993-5, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
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ISO 10993-10, Biological evaluation of medical devices Part 10: Tests for skin sensitization
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ISO 10993-23, Biological evaluation of medical devices Part 23: Tests for skin irritation
2) Electrical Safety and EMC
Electrical safety and EMC testing was performed to, and passed, the following standards:
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IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
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IEC 60601-1-2 Medical electrical equipments Part 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromagnetic disturbances - Requirements and tests
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IEC 60601-1-11 Medical Electrical Equipment Part 1: 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
3) Battery Safety
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IEC 62133-2 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
4) Software Verification and Validation
Software documentation consistent with basic documentation this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
IX. Conclusions
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Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device Air Compression Leg Massager is as safe, as effective, and performs as well as the primary predicate device and secondary predicate device.