Compressible Limb and Circulation Therapy System

K200660 · Wonjin Mulsan Co., Ltd. · IRP · Mar 8, 2021 · Physical Medicine

Device Facts

• Record ID: K200660
• Device Name: Compressible Limb and Circulation Therapy System
• Applicant: Wonjin Mulsan Co., Ltd.
• Product Code: IRP · Physical Medicine
• Decision Date: Mar 8, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

POWER RECOVERY 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 RECOVERY simulates kneading and stroking of tissues by using an inflatable garment (cuff).

Device Story

POWER RECOVERY is a powered inflatable tube massager for home, clinic, or athlete training use. System comprises main control unit, AC-DC adapter, and inflatable cuffs (leg, arm, hip) with hoses. Device operates by sequentially inflating and deflating cuff chambers to simulate tissue kneading and stroking. User selects from 5 modes (Sequential, Addition, Massage), pressure levels (60-150 mmHg), and durations (10, 20, 30 minutes). Powered by external supply or internal lithium-ion battery. Output is mechanical compression applied to limbs/hips to promote circulation and relieve muscle pain. Healthcare providers or patients operate device via control unit interface. Benefits include temporary muscle pain relief and improved local circulation.

Clinical Evidence

No clinical testing was performed. Substantial equivalence is supported by non-clinical bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), usability (IEC 60601-1-6, IEC 62366-1), and software life cycle (IEC 62304).

Technological Characteristics

Powered inflatable tube massager; 6-chamber (leg/arm) or 5-chamber (hip) cuffs. Pressure range 60-150 mmHg. Power: 15 VDC via IEC 60601-1 compliant supply or internal Li-ion battery. Control unit manages sequential/addition/massage modes. Software developed per IEC 62304. Standards: IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2.

Indications for Use

Indicated for healthy individuals seeking temporary relief of minor muscle aches and pains and temporary increase in blood circulation in treated areas (leg, arm, hip).

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

• Rapid Reboot Compression Therapy System (K182668)

Submission Summary (Full Text)

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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 8, 2021

Wonjin Mulsan Co., Ltd Ha Yong Jung 89, Geomdan-ro, Seo-gu, Incheon, 22653 Republic of Korea

Re: K200660

Trade/Device Name: Compressible Limb and Circulation Therapy System, Model POWER RECOVERY Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: December 8, 2020 Received: December 15, 2020

Dear Ha Jung:

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 (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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 (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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Heather Dean, PhD Assistant Director. Acute Injury Devices 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

#### K200660

Device Name

Compressible Limb and Circulation Therapy System, Model POWER RECOVERY

#### Indications for Use (Describe)

POWER RECOVERY 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 RECOVERY simulates kneading and stroking of tissues by using an inflatable garment (cuff).

| 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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# 510(K) Summary

[as required by 21 CFR 807.02]

| Date Prepared: | Feb. 17, 2021 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Wonjin Mulsan Co., Ltd.<br>89, Geomdan-ro, Seo-gu, Incheon, 22653, Republic of Korea<br>Tel: [phone], Fax: [phone]<br>Establishment Registration Number: 3006797972<br>Contact Person: HaYong Jung<br>Email: [e-mail] |
| Trade Name: | Compressible Limb and Circulation Therapy System<br>Model POWER RECOVERY |
| Common Name: | Powered Inflatable Tube Massager |
| Classification Name: | Massager, Powered Inflatable Tube |
| Regulation Number: | 890.5650 |
| Product Code: | IRP |
| Classification: | Class II |
| Predicate Device: | Rapid Reboot Compression Therapy System which was cleared for<br>marketing under K182668 |

#### Device Description

Compressible Limb and Circulation Therapy System Model POWER RECOVERY is a powered inflatable tube massager, and comprised of a main body, an AC-DC adapter, cuffs with hose, and a hose adapter and a main hose for connecting the device to the cuffs. The device is powered from an external IEC 60601-1 compliant power supply and can optionally be powered by an internal lithium ion battery. There are three cuffs to apply to different body areas, such as leg, arm, and hip. Leg cuff and arm cuff have 6-chambers and hip cuff has 5-chambers. The cuffs can be inflating and deflating sequentially to apply the pressure on the target body areas which are controlled by the main body. The device simulates kneading and stroking of tissues by using an inflatable garment (cuff) to temporarily relieve minor muscle aches and pains and to temporarily increase blood circulation to the tested areas in people who are in good health.

#### Indications for Use

POWER RECOVERY 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 RECOVERY simulates kneading and stroking of tissues by using an inflatable garment (cuff).

| Item | Description |
|----------------|-------------------------------------------------------------------------------------------------------------|
| Operation Mode | 5 modes such as SEQUENTIAL, ADDITION and MASSAGE |
| Pressure Range | Level 1 (60 mmHg) to Level 10 (150 mmHg) |
| Operation Time | 10, 20, and 30 minutes |
| Rest Time | Adjustable at interval of 0/5/10/30 sec at SEQUENTIAL mode<br>Fixed at 30 sec at ADDITION and MASSAGE modes |

#### Technologic Characteristics

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## Non-Clinical Testing

The device has been tested and met the requirements of the following standards:

IEC 60601-1:2005+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance ANSVAAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/(R)2012

IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for safety and essential performance - Collateral Standard: Usability

IEC 60601-1-11 Edition 2.0 2015-01 Medical electrical equipment - Part 1-11: General requirements for safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment ANSI/AAMI HA60601-1-11:2015

IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests

IEC 62366-1 Edition 1.0 2015-02 Medical device – Part 1: Application of usability engineering to medical devices

IEC 62304 Edition 1.1 2015-06 Medical device software - Software life cycle process

## Clinical Testing

No clinical testing was performed.

### Conclusions

Wonjin Mulsan Co., Ltd. believes that all applicable items of information specified in this submission have been supplied in full. The enclosed non-clinical data demonstrate that the subject device described herein raises no new questions concerning safety or effectiveness and may therefore be properly considered by the Agency as substantially equivalent to the predicate device that has previously been legally distributed in interstate commerce in the United States.

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## Comparison with Predicate Devices

| Item | Subject Device | Predicate Device | Differences |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| | | | Discussion |
| Model | POWER RECOVERY | Rapid Reboot Compression<br>Therapy System | NA |
| Manufacturer | Wonjin Mulsan Co., Ltd. | Rapid Reboot Recovery<br>Products, LLC | NA |
| Classification | Class II Device, IRP (21<br>CFR 890.5650) | Class II Device, IRP (21 CFR<br>890.5650) | NA |
| 510(k) number | K200660 | K182668 | NA |
| Indications for<br>use | POWER RECOVERY is<br>intended for the temporary<br>relief of minor muscle aches<br>and pains, and for temporary<br>increase in blood circulation<br>to the treated areas in people<br>who are in good health.<br>POWER RECOVERY<br>simulates kneading and<br>stroking of tissues by using<br>an inflatable garment (cuff). | The Rapid Reboot Compression<br>Therapy System is indicated for<br>the temporary relief of minor<br>muscle aches and pains and for<br>temporary increase in circulation<br>to the treated areas in people<br>who are in good health. The<br>Rapid Reboot Compression<br>Therapy System simulates<br>kneading and stroking of tissues<br>by using an inflatable garment. | Identical |
| Prescriptive or<br>OTC | OTC | OTC | Identical |
| Environment<br>of Use | Clinics, hospital, athlete<br>training, and home<br>environments | Clinics, hospital, athlete<br>training, and home<br>environments | Identical |
| Power<br>Source(s) | 15 VDC via in IEC 60601-1<br>compliant power supply<br>(100-240 VAC input),<br>Optional integrated<br>rechargeable battery | 110VAC, 60Hz | Minor<br>difference |
| Weight | 2 kg including battery | 2.63 kg (5.8 pounds) | Minor<br>difference |
| Dimensions<br>(W x H x D) | 114 x 141 x 245 mm | 25.4 x 16.51 x 12.7 cm<br>(10" x 6.5" x 5") | Minor<br>difference |
| Device<br>pressure range | 60-150 mmHg | 0-200 mmHg | Pressure range<br>of subject<br>device is smaller<br>than that of<br>predicate<br>device. |
| Treatment<br>Time | User can select operation<br>time among 10, 20, and 30<br>minutes. | User determines therapy time.<br>Choose from 10, 20, or 30<br>minute session time, with option<br>to add additional 10 minutes to<br>any therapy time. | Identical |
| Number of<br>inflatable<br>appliance<br>segments | 6 or less for leg and arm<br>cuffs<br>5 or less for hip cuff | 4 | Minor<br>difference |
| Sleeve and<br>chamber | Leg: 6-chambers<br>Arm: 6-chambers<br>Hip: 5-chambers | Leg: 4-chambers<br>Arm: 4-chambers<br>Hip: 4-chambers | Minor<br>difference |
| Anatomical<br>site | Leg (including of foot, calf,<br>knee, upper leg)<br>Hip (including of upper leg,<br>glutes, hips, lower lack)<br>Arm (including of entire arm,<br>shoulder) | Leg (including of foot, calf,<br>knee, upper leg)<br>Hip (including of upper leg,<br>glutes, hips, lower lack)<br>Arm (including of entire arm,<br>shoulder, upper chest and back) | Identical |
| Mode of<br>compression | Sequential, Addition, and<br>Massage | Sequential and Peristaltic | Refer to the<br>visual<br>description<br>below. |
| Mode of<br>compression<br>(visual<br>description) | Sequential<br>Image: Sequential compression | Mode A<br>Image: Mode A compression | Sequential mode<br>of POWER<br>RECOVERY is<br>similar to Mode<br>A of the<br>predicate. |
| | Addition<br>Image: Addition compression | Mode B<br>Image: Mode B compression | Addition mode<br>of POWER<br>RECOVERY is<br>similar to Mode<br>B of the<br>predicate. |
| | Massage:<br>Combination of<br>SEQUENTIAL and Addition<br>modes | None | Massage mode<br>of POWER<br>RECOVERY is<br>a combination<br>of<br>SEQUENTIAL<br>and Addition<br>modes. |

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Image /page/7/Picture/0 description: The image shows the appearance and size of cuffs for legs and hips. The leg cuffs are shown in two different styles, one with the word "RECOVERY" and the other with "RAPID REBOOT". The dimensions of the leg cuffs are 355x97mm (14" x 38.4") and X-Short: 14" x 41", Short: 14" x 43", Medium: 14" x 45", Long: 14" x 48", X-Long: 14" x 52". The hip cuffs are also shown in two different styles, with dimensions of 780x775mm (30.7" x 30.5") and Regular: 26" x 32", Large: 26" x 35".

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| | Arm<br>Image: Arm sleeves<br>Image: Arm sleeve dimension<br>300x945mm<br>(11.8" x 37.2") | Arm<br>Image: Arm wraps<br>Regular: 18" x 38"<br>Long: 18" x 44" | Minor<br>difference |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|---------------------|
| Other<br>accessories | Image: AC-DC Adapter<br>AC-DC Adapter<br>Image: Main Hose and Hose Adapter<br>Main Hose Hose Adapter<br>Image: Carrier<br>Carrier | "Not publicly available in the<br>official 510K Summary" | Minor<br>difference |