Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6)

K243206 · Sichuan Qianli-Beoka Medical Technology, Inc. · IRP · Feb 19, 2025 · Physical Medicine

Device Facts

• Record ID: K243206
• Device Name: Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6)
• Applicant: Sichuan Qianli-Beoka Medical Technology, Inc.
• Product Code: IRP · Physical Medicine
• Decision Date: Feb 19, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Air compression massager (ACM-PLUS-A1 through A6) is a powered inflatable tube massager; simulates manual kneading/stroking of tissues via inflatable pressure cuffs. Device consists of control unit with display and inflatable sleeves. Used in clinics, hospitals, athlete training, and home environments by users. Powered by internal 7.3V Li-ion battery. User interface allows adjustment of treatment time, pressure level (0-110 mmHg), and mode selection. Includes Bluetooth connectivity for control via Beoka app on Android/iOS. Device inflates/deflates chambers sequentially to provide massage. Output affects circulation and muscle relief; benefits patient through temporary pain relief and increased blood flow.

Clinical Evidence

No clinical test data was used to support the decision of substantial equivalence. Bench testing only.

Technological Characteristics

Powered inflatable tube massager; 5-chamber leg sleeves. Materials: Nylon, TPU, polyester fibre, PP. Power: 7.3V/2600mAh Li-ion battery. Connectivity: Bluetooth. Software: Microprocessor-controlled. Sterilization: Non-sterile. Standards: ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 10993-1/5/10/23, IEC 62133-2, IEEE ANSI C63.27.

Indications for Use

Indicated for people in good health to temporarily relieve minor muscle aches and/or pains and temporarily increase circulation to treated areas.

Regulatory Classification

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.

Predicate Devices

• Normatec Elite (K240122)
• RecoveryAir PRO (K211745)

Submission Summary (Full Text)

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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.

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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

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] 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

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## Indications for Use

Submission Number (if known)

K243206

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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## 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<br>district |
| City: | Chengdu |
| State/ Province: | Sichuan |
| Country: | China |
| Telephone: | [phone]; [phone] |
| Fax: | [phone] |
| Contact Person: | Caiqiuju |
| Contact Title: | Management representative |
| Contact Email: | [e-mail] |

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: [e-mail]

Phone: [phone]

## 2. Device Information

Trade Name: Air compression massager

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| Model: | ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4,<br>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.

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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<br>Number | FDA Recognition<br>Status | Outcome for<br>Device |
|-----------|---------------------------------------------------------------------------------------------------------------------------|---------------------------|-----------------------|
| Safety | ANSI AAMI ES60601-<br>1:2005/(R)2012 & A1:2012,<br>C1:2009/(R)2012 &<br>A2:2010/(R)2012 (Cons. Text)<br>[Incl. AMD2:2021] | Yes | Conforms |
| Page 3 of | | | |

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| EMC | IEC 60601-1-2:2020<br>IEC TS 60601-4-2: 2024 | Yes | Conforms |
|--------------------------------|-------------------------------------------------------------------------------------|-----|----------|
| Home healthcare<br>environment | IEC 60601-1-11:2020 | Yes | Conforms |
| Performance | Enterprise standard | Yes | Conforms |
| Biocompatibility | ISO 10993-1:2018;<br>ISO 10993-5:2009;<br>ISO 10993-10:2021;<br>ISO 10993-23: 2021. | Yes | Conforms |
| Software | ANSI AAMI IEC<br>62304:2006/A1:2016 | Yes | Conforms |
| Lithium battery | IEC 62133-2: 2017 | Yes | Conforms |
| Wireless Coexistence | IEEE ANSI USEMCSC<br>C63.27-2021<br>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<br>Qianli-beoka<br>Medical<br>Technology Inc. | NormaTec Industries, LP | Theragun Inc | NA |
| Product name | Air compression massager (Model No.:<br>ACM-PLUS-A1, ACM-PLUS-A2, ACM-<br>PLUS-A3, ACM-PLUS-A4, ACM-PLUS-<br>A5, ACM-PLUS-A6) | Normatec Elite | RecoveryAir PRO (Model RecoveryAir<br>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<br>Use (IFU) | The Air Compression Massager is an air<br>pressure<br>massager<br>intended<br>to<br>temporarily relieve minor muscle aches<br>and/or<br>pains, and to temporarily<br>increase circulation to the treated areas. | The Normatec Elite is an air pressure<br>massager intended to temporarily relieve<br>minor muscle aches and/or pains, and to<br>temporarily increase circulation to the<br>treated areas. | The RecoveryAir PRO is an air<br>compression therapy device intended to<br>provide graduated pressure to<br>compression garments.<br>The RecoveryAir PRO is indicated for the<br>temporary relief of minor muscle aches<br>and pains, and for temporary increase in<br>blood circulation to the treated areas in<br>people who are in good health.<br>The RecoveryAir PRO simulates<br>kneading and stroking of tissues by using<br>an inflatable garment. | Same |
| Anatomical<br>Coverage | Control unit mounted to inflatable<br>segment with integral hoses. | Control unit mounted to inflatable<br>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<br>Environment | Clinics, hospital, athlete training, and<br>home environments | Clinics, hospital, athlete training, and<br>home environments | Not publicly available | Same |
| Power<br>Source(s) | 7.3 V / 2600mAh Rechargeable Li-ion<br>battery | 12 VDC via an IEC 60601-1<br>compliant power supply (100-240 VAC input) Integrated rechargeable<br>battery | 100-240 V AC, 50/60 Hz, 12 V or internal<br>battery. | Minor<br>different<br>Note 1 |
| Software /<br>Firmware<br>Micro-<br>processor<br>Control | Microprocessor | Microprocessor | Microprocessor | Same |
| Technology | Compressor and valve system that<br>sequentially inflates cells.<br>Bluetooth communication ability. | Compressor and valve system that<br>sequentially inflates cells.<br>Bluetooth communication ability. | Compressor and valve system that<br>sequentially inflates cells.<br>Bluetooth communication ability. | Same |
| Output<br>Pressure<br>range | 0 - 110 mm Hg | 0 - 110 mm Hg | 20-100mmHg | Same:<br>the same as<br>the primary<br>predicate<br>device |
| Pressure<br>Levels | A total of 15 pressure levels, the lowest<br>level is 40mmHg, 5mmHg increments | Level 1: 40 mm Hg<br>Level 2: 50 - 60 mm Hg | Not publicly available | Minor<br>different |
| Device | Subject device | Primary Predicate device (K240122) | Secondary predicate device (K211745) | Comparison |
| | per level, and the highest level is<br>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<br>Time | Can be set up to turn off in a<br>range of 15 minutes to 60 minutes | Stays on until the user turns it off<br>or can be set up to turn off in a<br>range of 15 minutes to 60 minutes | 10min-90min, step of 5min | Same:<br>The same as<br>the primary<br>predicate<br>device |
| Inflation/Deflation<br>Cycle<br>Type | Sequential Gradient, Peristaltic<br>and Pulsing | Sequential Gradient, Peristaltic<br>and Pulsing | Sequential Gradient, Peristaltic<br>and Pulsing | Same |
| Contact<br>Surface<br>Material | Nylon, TPU, metal, polyester fibre, PP | 200 denier nylon with a<br>polyurethane laminate/extrusion | Polyether Nylon Fabric | Different<br>Note 3 |
| Number of<br>Inflatable<br>segments | 5 segments for leg attachment | 5 segments for leg attachment | 4 segments for leg attachment | Same:<br>The same as<br>the primary<br>predicate<br>device |
| Weight | S size: 3.2kg; M size:3.3kg;<br>L size :3.5kg; XL: 3.7Kg | 3.0 lbs | 4.202 pounds | Minor<br>different |
| Control Unit<br>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<br>of<br>sleeves | S(L840xW330xH120)mm;<br>M(L950 X W380 X H140)mm;<br>L(L1020xW380xH150)mm;<br>XL(L1100xW410xH150)mm | Not publicly available | RecoveryAir Compression Boots: 95*28.7<br>cm | |
| Housing<br>Materials<br>And<br>Construction | Molded ABS enclosure | Molded ABS enclosure | Molded ABS enclosure | Same |
| Patient<br>contact | Non-conductive wrap<br>Surface Device<br>Intact Skin | Non-conductive wrap<br>Surface Device<br>Intact Skin | Non-conductive appliances | Same |
| Modes<br>(massage<br>sequences) | A total of 5 mode can be selected:<br>M1 Fatigue relief mode<br>M2 Training activation mode<br>M3 Workout recovery mode<br>M4 Overall relaxation mode<br>M5 Deep care mode<br><br><b>M1 Fatigue relief mode and M2 Training activation mode:</b><br>The Massage sequence:<br>①→①<br>②→① ②→③→① ② ③→① ② ③④→① ②<br>③④⑤ | Not publicly available | Sequential, ISO or Rehab (wave), Flow<br>cycles<br><br><b>Sequential mode:</b><br>Sequential mode that applies a directional<br>massage, starting at the base of the<br>treated area, and progresses upwards<br>towards the torso and then releases:<br><br><br> | Minor<br>different<br>Note 4 |
| | <b>M3 Workout recovery mode:</b> | | <b>ISO mode:</b> | |
| Device | Subject device | Primary Predicate device (K240122) | Secondary predicate device (K211745) | Comparison |
| | ①*→①②*→①②③*→②③④*→<br>③④⑤* (The chamber marked with"*"<br>means this chamber will be inflated-<br>deflated for 3 times) | | ISO mode that applies a directional<br>massage to a smaller, user selected area.<br>The first chamber inflates, and after a few<br>seconds, the second chamber starts to<br>inflate until both chambers reach the set<br>pressure. Then both chambers deflate,<br>and after a pause the process starts again | |
| | M4 Overall relaxation mode:<br>The default Massage sequence of one<br>cycle:<br>(①)×2→ (①→①②)×2→<br>((①→①②)→(①②③))×2→<br>(①→①②→①②③→①②③④)×2<br>→<br>(①→①②→①②③→①②③④→①<br>②③④⑤)×2<br>Under the default Massage sequence,<br>each step is inflate-deflated for 2 times,<br>which we call frequency 2. The<br>frequency can be set to 1~5 through the<br>APP:<br>Frequency 1: each step is inflate-<br>deflated for 1 time, and then go to the<br>next step.<br>Frequency 2: each step is inflate-<br>deflated for 2 times,and then go to the<br>next step.<br>Frequency 3: each step is inflate- | | <br>Image: Chambers 1 & 2 (Distal)<br><br>Image: Chambers 2 & 3 (Mid)<br><br>Image: Chambers 3 & 4 (Proximal) | |
| |…