(141 days)
Not Found
No
The description focuses on basic user interface controls, Bluetooth connectivity for app control, and standard safety/performance testing. There is no mention of adaptive algorithms, data analysis for personalized treatment, or any other characteristics typically associated with AI/ML in medical devices.
Yes
Explanation: The device is intended to temporarily relieve minor muscle aches and/or pains and temporarily increase circulation, which are therapeutic claims.
No
Explanation: The device is described as an "Air Compression Massager" intended to temporarily relieve minor muscle aches and/or pains and increase circulation. It simulates manual kneading and stroking. There is no mention of it being used to diagnose conditions or process diagnostic information.
No
The device description clearly states it is a "powered inflatable tube massager" with an internal battery, physical buttons, a display screen, and Bluetooth capability to connect to a mobile app. While a software app is mentioned for control, the core medical device is a hardware-based air compression massager.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas." This is a physical therapy/massage function, not a diagnostic test performed on biological samples.
- Device Description: The device is described as an "air pressure massager" that "simulates manual kneading and stroking of tissues." This aligns with a physical therapy device, not a device used for in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
In summary, the device's function and description clearly indicate it is a physical therapy or massage device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Air Compression Massager is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.
Product codes
IRP
Device Description
The Air compression massager is a powered inflatable tube massager. It is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. It simulates manual kneading and stroking of tissues by the use of an inflatable pressure cuff. The devices are to be used by people who are in good health. The devices are powered by an internal IEC 62133-2 compliant lithium-ion battery.
The user interface on the Air compression massager is a series of buttons with a small display screen to display the treatment time, pressure level, mode and chamber status. The user interface provides for:
- Starting and stopping the massage treatment;
- Adjusting treatment related parameters such as treatment time and pressure level etc.;
- Selection of the chamber to boost the pressure.
In addition to the user interface on the devices, the subject device have Bluetooth capability that allows the use of a Beoka app to control the device. The Bluetooth app allows the user to use a compatible Android or iOS phone to select and set device parameters listed above for convenience.
The product is provided non-sterile, and not to be sterilized by the user prior to use.
All models in this submission are the same except for the color of controller and button shape.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Control unit mounted to inflatable segment with integral hoses.
Indicated Patient Age Range
Not Found
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)
A series of safety and performance tests were conducted on the subject device.
- Product service life
- Software validation
- Electromagnetic compatibility and electrical safety
- Function test
- Wireless Coexistence
All the test results demonstrate Air compression massager meets the requirements of its pre-defined acceptance criteria and intended use, and it is substantially equivalent to the predicate devices.
No clinical test data was used to support the decision of substantial equivalence.
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" and the words "U.S. Food & Drug Administration".
February 19, 2025
Sichuan Qianli-beoka Medical Technology Inc. % Reanny Wang General Manager Shenzhen Reanny Medical Devices Mgmt Consulting Co., Ltd Room 1509, Jingting Building, Dongzhou Community Guangming Street, Guangming District Shenzhen, Guangdong China
Re: K243206
Trade/Device Name: Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6) Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: September 23, 2024 Received: October 1, 2024
Dear Reanny Wang:
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.
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 the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/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
Submission Number (if known)
Device Name
Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6)
Indications for Use (Describe)
The Air Compression Massager is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X | Over-The-Counter Use (21 CFR 801 Subpart C)
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4
Traditional 510(k) Summary K243206
1. Information of Submitter and Correspondent
Submitter's information:
| Company Name: | Sichuan Qianli-beoka Medical Technology Inc. |
|---|---|
| Street Address: | Longtan Industrial Park 2nd Sec, east 3rd ring road, Chenghua |
| district | |
| City: | Chengdu |
| State/ Province: | Sichuan |
| Country: | China |
| Telephone: | +86 028 84215340; +86 13518172086 |
| Fax: | +86 028 84215341 |
| Contact Person: | Caiqiuju |
| Contact Title: | Management representative |
| Contact Email: | caiqiuju@beoka.com |
Date Prepared: Sep. 23, 2024
Submission correspondent's information:
Shenzhen Reanny Medical Devices Management Consulting Co., Ltd
- Address: Room 1509, Jingting Building, Dongzhou Community, Guangming Street, Guangming District, Shenzhen 518107, China
Contact Person: Reanny Wang
E-mail: reanny@reanny.com
Phone: +86(755) 27391220
2. Device Information
Trade Name: Air compression massager
5
| Model: | ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4,
ACM-PLUS-A5, ACM-PLUS-A6 |
|----------------------|---------------------------------------------------------------------------------|
| Common Name: | Powered Inflatable Tube Massager |
| Classification Name: | Massager, Powered Inflatable Tube |
| Regulation: | 21 CFR § 890.5650 |
| Device Class: | Class 2 |
| Product Code: | IRP |
3. Identification of Predicate Device(s)
| Manufacturer | NormaTec Industries, LP | Theragun Inc |
|---|---|---|
| Legally Marketed Device | Normatec Elite | RecoveryAir PRO |
| 510(K) Number | K240122 | K211745 |
4. Description of Device
The Air compression massager is a powered inflatable tube massager. It is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. It simulates manual kneading and stroking of tissues by the use of an inflatable pressure cuff. The devices are to be used by people who are in good health. The devices are powered by an internal IEC 62133-2 compliant lithium-ion battery.
The user interface on the Air compression massager is a series of buttons with a small display screen to display the treatment time, pressure level, mode and chamber status. The user interface provides for:
- · Starting and stopping the massage treatment;
· Adjusting treatment related parameters such as treatment time and pressure level etc.;
· Selection of the chamber to boost the pressure.
In addition to the user interface on the devices, the subject device have Bluetooth capability that allows the use of a Beoka app to control the device. The Bluetooth app allows the user to use a compatible Android or iOS phone to select and set device parameters listed above for convenience.
6
The product is provided non-sterile, and not to be sterilized by the user prior to use.
All models in this submission are the same except for the color of controller and button shape.
5. Indications for Use
The Air Compression Massager is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.
6. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
6.1 Non-clinical testing
A series of safety and performance tests were conducted on the subject device.
- Product service life
- Software validation
- Electromagnetic compatibility and electrical safety
- Function test
- Wireless Coexistence
All the test results demonstrate Air compression massager meets the requirements of its pre-defined acceptance criteria and intended use, and it is substantially equivalent to the predicate devices.
6.2 Clinical Testing
No clinical test data was used to support the decision of substantial equivalence.
7. Performance Summary
The devices conform to applicable standards as follow table:
| Test Type | Standard Designation
Number | FDA Recognition
Status | Outcome for
Device |
|-----------|---------------------------------------------------------------------------------------------------------------------------|---------------------------|-----------------------|
| Safety | ANSI AAMI ES60601-
1:2005/(R)2012 & A1:2012,
C1:2009/(R)2012 &
A2:2010/(R)2012 (Cons. Text)
[Incl. AMD2:2021] | Yes | Conforms |
| Page 3 of | | | |
7
| EMC | IEC 60601-1-2:2020
IEC TS 60601-4-2: 2024 | Yes | Conforms |
|--------------------------------|-------------------------------------------------------------------------------------|-----|----------|
| Home healthcare
environment | IEC 60601-1-11:2020 | Yes | Conforms |
| Performance | Enterprise standard | Yes | Conforms |
| Biocompatibility | ISO 10993-1:2018;
ISO 10993-5:2009;
ISO 10993-10:2021;
ISO 10993-23: 2021. | Yes | Conforms |
| Software | ANSI AAMI IEC
62304:2006/A1:2016 | Yes | Conforms |
| Lithium battery | IEC 62133-2: 2017 | Yes | Conforms |
| Wireless Coexistence | IEEE ANSI USEMCSC
C63.27-2021
AAMI TIR69:2017/(R2020) | Yes | Conforms |
8. Discussion of Comparison to Predicate Devices.
The Air compression massager submitted in this 510(k) submission is substantially equivalent in intended use, technological characteristics and performance to the cleared Normatec Elite K240122 and RecoveryAir PRO K211745. Differences between the subject and predicate devices do not raise new questions of safety and effectiveness.
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| Device | Subject device | Primary Predicate device (K240122) | Secondary predicate device (K211745) | Comparison |
|---|---|---|---|---|
| Manufacturer | Sichuan | |||
| Qianli-beoka | ||||
| Medical | ||||
| Technology Inc. | NormaTec Industries, LP | Theragun Inc | NA | |
| Product name | Air compression massager (Model No.: | |||
| ACM-PLUS-A1, ACM-PLUS-A2, ACM- | ||||
| PLUS-A3, ACM-PLUS-A4, ACM-PLUS- | ||||
| A5, ACM-PLUS-A6) | Normatec Elite | RecoveryAir PRO (Model RecoveryAir | ||
| PRO) | NA | |||
| Classification | Class II Device, IRP (21 CFR890.5650) | Class II Device, IRP (21 CFR890.5650) | Class II Device, IRP (21 CFR890.5650) | Same |
| OTC or Rx | OTC | OTC | OTC | Same |
| Indications for | ||||
| Use (IFU) | The Air Compression Massager is an air | |||
| pressure | ||||
| massager | ||||
| intended | ||||
| to | ||||
| temporarily relieve minor muscle aches | ||||
| and/or | ||||
| pains, and to temporarily | ||||
| increase circulation to the treated areas. | The Normatec Elite is an air pressure | |||
| massager intended to temporarily relieve | ||||
| minor muscle aches and/or pains, and to | ||||
| temporarily increase circulation to the | ||||
| treated areas. | 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 | ||||
| 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. | Same | |||
| Anatomical | ||||
| Coverage | Control unit mounted to inflatable | |||
| segment with integral hoses. | Control unit mounted to inflatable | |||
| segment with integral hoses. | Not publicly available | Same | ||
| Device | Subject device | Primary Predicate device (K240122) | Secondary predicate device (K211745) | Comparison |
| Image: beoka air compression massager | Image: Normatec | |||
| Intended Use | ||||
| Environment | Clinics, hospital, athlete training, and | |||
| home environments | Clinics, hospital, athlete training, and | |||
| home environments | Not publicly available | Same | ||
| Power | ||||
| Source(s) | 7.3 V / 2600mAh Rechargeable Li-ion | |||
| battery | 12 VDC via an IEC 60601-1 | |||
| compliant power supply (100-240 VAC input) Integrated rechargeable | ||||
| battery | 100-240 V AC, 50/60 Hz, 12 V or internal | |||
| battery. | Minor | |||
| different | ||||
| Note 1 | ||||
| Software / | ||||
| Firmware | ||||
| Micro- | ||||
| processor | ||||
| Control | Microprocessor | Microprocessor | Microprocessor | Same |
| Technology | Compressor and valve system that | |||
| sequentially inflates cells. | ||||
| Bluetooth communication ability. | Compressor and valve system that | |||
| sequentially inflates cells. | ||||
| Bluetooth communication ability. | Compressor and valve system that | |||
| sequentially inflates cells. | ||||
| Bluetooth communication ability. | Same | |||
| Output | ||||
| Pressure | ||||
| range | 0 - 110 mm Hg | 0 - 110 mm Hg | 20-100mmHg | Same: |
| the same as | ||||
| the primary | ||||
| predicate | ||||
| device | ||||
| Pressure | ||||
| Levels | A total of 15 pressure levels, the lowest | |||
| level is 40mmHg, 5mmHg increments | Level 1: 40 mm Hg | |||
| Level 2: 50 - 60 mm Hg | Not publicly available | Minor | ||
| different | ||||
| Device | Subject device | Primary Predicate device (K240122) | Secondary predicate device (K211745) | Comparison |
| per level, and the highest level is | ||||
| 110mmHg | Level 3: 60 - 70 mm Hg | Note 2 | ||
| Level 4: 70 - 80 mm Hg | ||||
| Level 5: 80 mm Hg | ||||
| Level 6: 80-90 mm Hg | ||||
| Level 7: 100 mm Hg | ||||
| Treatment | ||||
| Time | Can be set up to turn off in a | |||
| range of 15 minutes to 60 minutes | Stays on until the user turns it off | |||
| or can be set up to turn off in a | ||||
| range of 15 minutes to 60 minutes | 10min-90min, step of 5min | Same: | ||
| The same as | ||||
| the primary | ||||
| predicate | ||||
| device | ||||
| Inflation/Deflation | ||||
| Cycle | ||||
| Type | Sequential Gradient, Peristaltic | |||
| and Pulsing | Sequential Gradient, Peristaltic | |||
| and Pulsing | Sequential Gradient, Peristaltic | |||
| and Pulsing | Same | |||
| Contact | ||||
| Surface | ||||
| Material | Nylon, TPU, metal, polyester fibre, PP | 200 denier nylon with a | ||
| polyurethane laminate/extrusion | Polyether Nylon Fabric | Different | ||
| Note 3 | ||||
| Number of | ||||
| Inflatable | ||||
| segments | 5 segments for leg attachment | 5 segments for leg attachment | 4 segments for leg attachment | Same: |
| The same as | ||||
| the primary | ||||
| predicate | ||||
| device | ||||
| Weight | S size: 3.2kg; M size:3.3kg; | |||
| L size :3.5kg; XL: 3.7Kg | 3.0 lbs | 4.202 pounds | Minor | |
| different | ||||
| Control Unit | ||||
| Dimensions | L173 X W100 X H52mm | 3.5" x 1.75" x 7.0"(W x H x D) | 8.6in (L) *6.7in (W) *5.1in (H) | Note 1 |
| Device | Subject device | Primary Predicate device (K240122) | Secondary predicate device (K211745) | Comparison |
| Size | ||||
| of | ||||
| sleeves | S(L840xW330xH120)mm; | |||
| M(L950 X W380 X H140)mm; | ||||
| L(L1020xW380xH150)mm; | ||||
| XL(L1100xW410xH150)mm | Not publicly available | RecoveryAir Compression Boots: 95*28.7 | ||
| cm | ||||
| Housing | ||||
| Materials | ||||
| And | ||||
| Construction | Molded ABS enclosure | Molded ABS enclosure | Molded ABS enclosure | Same |
| Patient | ||||
| contact | Non-conductive wrap | |||
| Surface Device | ||||
| Intact Skin | Non-conductive wrap | |||
| Surface Device | ||||
| Intact Skin | Non-conductive appliances | Same | ||
| Modes | ||||
| (massage | ||||
| sequences) | A total of 5 mode can be selected: | |||
| M1 Fatigue relief mode | ||||
| M2 Training activation mode | ||||
| M3 Workout recovery mode | ||||
| M4 Overall relaxation mode | ||||
| M5 Deep care mode |
M1 Fatigue relief mode and M2 Training activation mode:
The Massage sequence:
①→①
②→① ②→③→① ② ③→① ② ③④→① ②
③④⑤ | Not publicly available | Sequential, ISO or Rehab (wave), Flow
cycles
Sequential mode:
Sequential mode that applies a directional
massage, starting at the base of the
treated area, and progresses upwards
towards the torso and then releases:
| Minor
different
Note 4 |
| | M3 Workout recovery mode: | | ISO mode: | |
| Device | Subject device | Primary Predicate device (K240122) | Secondary predicate device (K211745) | Comparison |
| | ①*→①②*→①②③*→②③④*→
③④⑤* (The chamber marked with"*"
means this chamber will be inflated-
deflated for 3 times) | | 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 | |
| | M4 Overall relaxation mode:
The default Massage sequence of one
cycle:
(①)×2→ (①→①②)×2→
((①→①②)→(①②③))×2→
(①→①②→①②③→①②③④)×2
→
(①→①②→①②③→①②③④→①
②③④⑤)×2
Under the default Massage sequence,
each step is inflate-deflated for 2 times,
which we call frequency 2. The
frequency can be set to 1~5 through the
APP:
Frequency 1: each step is inflate-
deflated for 1 time, and then go to the
next step.
Frequency 2: each step is inflate-
deflated for 2 times,and then go to the
next step.
Frequency 3: each step is inflate- | |
Image: Chambers 1 & 2 (Distal)
Image: Chambers 2 & 3 (Mid)
Image: Chambers 3 & 4 (Proximal) | |
| | | | 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 the deflation on 1st | |
| Device | Subject device | Primary Predicate device (K240122) | Secondary predicate device (K211745) | Comparison |
| | deflated for 3 times,and then go to the
next step. | | chamber , the 2nd and 3rd chambers
starts to inflate until the both chambers
reach the set pressure; then deflate the
2nd chambers inflate 3rd and 4th
chambers until the both chambers reach
the set pressure | |
| | Frequency 4: each step is inflate-
deflated for 4 times, and then go to the
next step. | | Image: Wave cycle mode | |
| | Frequency 5: each step is inflate-
deflated for 5 times, and then go to the
next step. | | | |
| | M5 Deep care mode | | | |
| | The Massage sequence:
1 → 2 → 3 → 4 → 5 | | | |
| | Remark: (1), (2), (3), (4) and (5) represent
the first, second, third, fourth and fifth
chambers from the distal end to the
proximal end. | | | |
| | Image: Foot with chambers | | | |
| | | | | |
| | | | Flow cycles:
Progress 1: first inflate Chamber 1 to
target pressure, then hold & release. then
go to Progress 2.
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 | |
| Device | Subject device | Primary Predicate device (K240122) | Secondary predicate device (K211745) | Comparison |
| | | | 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 chamber 1
& 2, & start to inflate 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. | |
9
10
11
12
13
14
15
| Device | Subject device | Primary Predicate device (K240122) | Secondary predicate device (K211745) | Comparison | |||
|---|---|---|---|---|---|---|---|
| Chamber 1 | Chamber 2 | Chamber 3 | Chamber 4 | ||||
| Image: Chamber 1 diagram | |||||||
| Sanianca | |||||||
| Progress | Image: Chamber 2 diagram | ||||||
| Sonianca | |||||||
| Progress | Image: Chamber 3 diagram | ||||||
| Sanianca | |||||||
| Progress | Image: Chamber 4 diagram | ||||||
| Sanianca | |||||||
| Progress |
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The discussion of differences exist between the subject and predicate devices is listed as follows:
Note 1:
Although the device design and specification parameter between the predicate devices and subject device are different, they are both complied with ANSI/AAMI ES60601-1. So the minor differences on such parameters (power source, Control Unit Dimensions ,Size of sleeves and weight) do not affect the safety and effectiveness.
Note 2:
Although the "pressure levels" of subject device is different from the predicate device, their output pressure range are the same, so the pressure level different do not affectiveness. Additionally, the subject device conforms to ANSI/AAMI ES60601-1, so the small differences do not affect the safety and effectiveness.
Note 3:
Although the "Contact Surface Material" is difference from that of predicate devices, both the Contact Surface Material of subject device and predicate devices comply with ISO 10993-10 and/or ISO -10003-23. Therefore, the difference would not raise adversely impact on safety and effectiveness.
Note 4:
The massage sequence of M1 Fatigue relief mode and M2 Training activation mode are similar to Sequential mode of secondary predicate device.
The massage sequence of M3 Workout recovery mode is similar to the Wave mode of secondary predicate device, both of them always keep several chambers in working status, the difference is that in the working chambers of M3 Workout recovery mode, the proximal working chamber will be inflateddeflated a total of three times. Due to the overall massage sequence of M3 Workout recovery mode and Wave mode are consistent, and the massage pressure range of subject device is within the range of predicate devices, so the small differences do not affect the safety and effectiveness.
M4 Overall relaxation mode: The massage sequence of M4 Overall relaxation mode is similar to the Flow cycles of secondary predicate device, their progress is consistent, with the only difference being that the frequency of the M4 Overall relaxation mode can be adjusted, so that the progress in each step increases the inflating-deflating times according to the adjusted frequency. Due to the overall massage sequence of M4 Overall relaxation mode and Flow cycles are consistent, and the massage pressure range of subject device is within the range of predicate devices, so the small differences do not affect the safety and effectiveness.
The massage sequence of M5 Deep care mode is from the distal end to proximal end, similar to the Wave mode of secondary predicate device. The difference is that the M5 Deep care mode only keeps one chamber in working status at a time, while the Wave mode keeps two chambers in working status at a time. Due to the overall massage sequence of M5 Deep care mode and Wave mode are consistent (From the distal end to proximal end), and the massage pressure range of subject device is within the range of predicate devices, so the small differences do not affect the safety and effectiveness.
9. Conclusions
The subject device has same intended use and similar technological characteristics as the predicate devices. Although there are several specifications that are different between these devices, testing and discussion had been completed to demonstrate that the differences between these parameters would
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not adversely impact the safety and effectiveness of the subject device. The subject device has undergone safety and performance tests, and the results conformed with the test requests. Therefore, the differences between the subject device and the predicate devices do not raise any concerns with respect to substantial equivalence. The subject device is substantially equivalent to the predicate devices and the differences in technological characteristics do not raise different questions of safety and effectiveness based on the testing submitted to support this submission.