Lymphedema Compression

K240011 · Jkh Health Co., Ltd. · JOW · Feb 23, 2024 · Cardiovascular

Device Facts

• Record ID: K240011
• Device Name: Lymphedema Compression
• Applicant: Jkh Health Co., Ltd.
• Product Code: JOW · Cardiovascular
• Decision Date: Feb 23, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Lymphedema Compression is comprised of a gradient compression sleeve and a portable intermittent pump to provide graduated compression in both sustained and intermittent settings for use in both the hospital and outpatient setting. It is pre-set to the default setting of 50 mmHg that cannot be adjusted or can be adjusted by the physician to a pressure within the specified range. It is intended for use in: Treatment of lymphedema Treatment of chronic venous insufficiency Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers Reducing venous leg ulcer healing time Reducing edema due to venous stasis Enhancing venous return The device is intended for home, and hospital use.

Device Story

Portable, rechargeable intermittent pneumatic compression device; consists of control unit with air pump and inflatable cuff/sleeve. Used in home or hospital settings by patients or clinicians. Input: user-selected or default (50 mmHg) pressure settings. Operation: microprocessor-controlled pump inflates multiple air chambers in sequence (foot to knee) to compress extremities, followed by deflation cycle. Output: cyclic pneumatic pressure to aid venous return. Healthcare providers use device to manage lymphedema and venous conditions; output affects clinical decision-making by providing non-invasive edema reduction. Benefits include improved venous return and ulcer healing. Device features audible/visual alarms for system faults and low battery.

Clinical Evidence

No clinical data. Bench testing only, including electrical safety (ANSI AAMI ES60601-1), electromagnetic compatibility (IEC 60601-1-2), and software verification per FDA guidance.

Technological Characteristics

Microprocessor-controlled pneumatic pump; 5V DC power supply (100-240 VAC) and 3.7V rechargeable battery. Cuff consists of multiple air chambers encased in biocompatible nylon fabric. Dimensions/form factor: portable, ambulant. Connectivity: standalone. Sterilization: clean, non-sterile. Software: moderate level of concern.

Indications for Use

Indicated for patients requiring venous return and lymphedema treatment, including chronic venous insufficiency, stasis dermatitis, venous stasis ulcers, and edema due to venous stasis. Contraindicated for patients with suspected/active deep vein thrombosis, ischemic vascular disease, severe arteriosclerosis, pulmonary edema, severe congestive heart failure, thrombophlebitis, active infection, neuropathy, or insensitive extremities. Not for use where increased venous/lymphatic return is undesirable or on legs with vein ligation, gangrene, open wounds, recent skin grafts, massive edema, or extreme deformity.

Regulatory Classification

Identification

A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.

Predicate Devices

• ManaFlow (K200353)

Submission Summary (Full Text)

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February 23, 2024

JKH Health Co., Ltd. % Bill Dai Managing Member Jkh Usa LLC 20 Fairbanks. Suite 171 Irvine, California 92618

Re: K240011

Trade/Device Name: Lymphedema Compression Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible limb sleeve Regulatory Class: Class II Product Code: JOW Dated: December 8, 2023 Received: January 2, 2024

### Dear Bill Dai:

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.

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).

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approvals in the device master record (21 CFR 820.181).

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 OS 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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Image /page/1/Picture/6 description: The image shows the name "Eric E. Richardson -S" in a clear, sans-serif font. The text is positioned on the left side of the image. To the right of the name, there is a faint, stylized logo that appears to be a company or organization emblem.

for Nicole Gillette Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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# Indications for Use

Submission Number (if known)

K240011

Device Name

Lymphedema Compression

#### Indications for Use (Describe)

The Lymphedema Compression is comprised of a gradient compression sleeve and a portable intermittent pump to provide graduated compression in both sustained and intermittent settings for use in both the hospital and outpatient setting. It is pre-set to the default setting of 50 mmHg that cannot be adjusted or can be adjusted by the physician to a pressure within the specified range. It is intended for use in:

- Treatment of lymphedema
- · Treatment of chronic venous insufficiency
- · Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers
- · Reducing venous leg ulcer healing time
- · Reducing edema due to venous stasis
- Enhancing venous return

The device is intended for home, and hospital use.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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### 510(k) Summary

### 1. Submitter's Information

JKH Health Co., Ltd. Address: 4-5F, Building 12, Hengmingzhu Industrial Park, Xinqiao Tongfuyu Industrial Area, Shajing, Baoan, Shenzhen, China Tel: [phone] Fax: [phone] E-mail: [e-mail] Date of Preparation: 12/8/2023

## 2. Subject Device

Trade/Device Name: Lymphedema Compression Common Name: Compressible Limb Sleeve Regulation Medical Specialty: Cardiovascular Review Panel: Cardiovascular Product Code: JOW Regulation Number: 21 CFR 870.5800 Device Class: II Use: Prescription

### 3. Predicate device

Predicate Device: ManaFlow 510(k) Number: K200353 Clearance Date: August 6, 2020 Submitter: ManaMed, Inc.

## 4. Description of Subject Device

As a portable and rechargeable prescriptive device, the Lymphedema Compression is intended to be used in the home or clinical/hospital setting by or under the direction of a medical professional. It applies pressure to treat lymphedema and other edematous conditions.

Supplied clean and non-sterile, the Lymphedema Compression utilizes the pneumatically controlled cuff and is actuated by an electronically controlled air pump unit. All pump, battery and control components are protectively housed in a plastic case of the control unit, which is attached to an inflatable cuff/sleeve. The Lymphedema Compression contains an ON/OFF button, a SET button, and a display for user interface. In addition, there is also a port on the control unit for connecting the battery charger/AC adapter plug. The cuff component consists of multiple air chambers/bladders encased inside a soft nylon fabric or equivalent biocompatible fabric for increased patient comfort and biocompatibility compliance.

In operation, the user simply press the ON/OFF button to turn on the control unit, to which a cuff containing air chambers/bladders is connected. And the control unit then inflates the cuff to the default pre-determined pressure (50 mmHg) that cannot be adjusted to a pressure within the specified range via the SET button. Once the cuff pressure of the multiple air chambers/bladders reaches the pre-determined or adjusted level, the pump is turned off, and the cuff deflates to the ambient pressure through a valve inside the control unit. After the rest period, the cycle of inflation and deflation repeats until the device is turned off automatically or manually.

#### 5. Indications for Use

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## Prescription Use:

The Lymphedema Compression is comprised of a gradient compression sleeve and a portable intermittent pump to provide graduated compression in both sustained and intermittent settings for use in both the hospital and outpatient setting. It is pre-set to the default setting of 50 mmHg that cannot be adjusted or can be adjusted by the physician to a pressure within the specified range. It is intended for use in:

- Treatment of lymphedema ●
- Treatment of chronic venous insufficiency
- Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers
- . Reducing venous leg ulcer healing time
- Reducing edema due to venous stasis
- Enhancing venous return

The device is intended for home, and hospital use.

#### 6. Summary of Substantial Equivalence

The following comparison Table 1 summarizes the comparison between the subject device and the predicate device, indicating the intended use and technical characteristics of the subject device are substantially equivalent to those of the predicate device.

| | Subject Device | Primary Predicate Device | Equivalence |
|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| 510(k) Number | N/A | K200353 | N/A |
| Device Name/Model | Lymphedema Compression | ManaFlow | N/A |
| Submitter | JKH Health Co., Ltd. | ManaMed, Inc. | N/A |
| Intended Use | The Lymphedema Compression is<br>comprised of a gradient compression sleeve<br>and a portable intermittent pump to provide<br>graduated compression in both sustained<br>and intermittent settings for use in both the<br>hospital and outpatient setting. It is pre-set<br>to the default setting of 50 mmHg that<br>cannot be adjusted or can be adjusted by the<br>physician to a pressure within the specified<br>range. It is intended for use in:<br>Treatment of lymphedema<br>Treatment of chronic venous<br>insufficiency<br>Treatment and promotion of<br>healing of stasis dermatitis and venous<br>stasis ulcers<br>Reducing venous leg ulcer<br>healing time<br>Reducing edema due to venous<br>stasis<br>Enhancing venous return<br>The device is intended for home, and<br>hospital use. | The ManaFlow system, part numbers<br>MFLOW51 and MFLOW52, is comprised of<br>a gradient compression sleeve and a portable<br>intermittent pump to provide graduated<br>compression in both sustained and<br>intermittent settings for use in both the<br>hospital and outpatient setting. ManaFlow 51<br>is pre-set to the default setting of 50 mmHg<br>and cannot be adjusted, whereas the<br>ManaFlow 52 can be adjusted by the<br>physician to a pressure within the specified<br>range. It is intended for use in:<br>Treatment of lymphedema<br>Treatment of chronic venous<br>insufficiency<br>Treatment and promotion of<br>healing of stasis dermatitis and venous stasis<br>ulcers<br>Reducing venous leg ulcer healing<br>time<br>Reducing edema due to venous<br>stasis<br>Enhancing venous return | Identical |
| | | The device is intended for home, and hospital<br>use. | |
| Prescription or OTC | Prescription | Prescription | Identical |
| Power Source(s) | 5V DC power supply (100-240 VAC input)<br>and 3.7V rechargeable battery | 5V DC power supply (100-240 VAC input)<br>and 3.7V rechargeable battery | Identical |
| Battery Charge | Takes approximately 4 hours (from depleted<br>state). | Takes approximately 4 hours (from depleted<br>state). | Identical |
| Power Supply | Input: 100 - 240 Vac, 50 - 60 Hz,<br>Output: 5 Vdc @ 2 Amp) | Input: 100 - 240 Vac, 50 - 60 Hz,<br>Output: 5 Vdc @ 2 Amp) | Identical |
| Internal rechargeable<br>batteries | Yes | Yes | Identical |
| Compliance with<br>Voluntary Standards? | Yes | Yes | Identical |
| Electrical Safety<br>Mechanical Safety<br>Chemical Safety<br>Thermal Safety<br>Radiation Safety? | Yes | Yes | Identical |
| Functions and design | Aids venous return by using cyclic,<br>intermittent, pneumatic pressure application<br>(inflation followed by deflation) to<br>compress the extremities. | Aids venous return by using cyclic,<br>intermittent, pneumatic pressure application<br>(inflation followed by deflation) to compress<br>the extremities. | Identical |
| Contraindication(s) | MUST NOT be used to treat the following<br>conditions: Persons with suspected, active<br>or untreated: deep vein thrombosis,<br>ischemic vascular disease, severe<br>arteriosclerosis, pulmonary edema,<br>severe congestive heart failure,<br>thrombophlebitis, or an active infection.<br>On the legs where cuffs would interfere<br>with the following conditions: vein ligation,<br>gangrene, dermatitis, open wounds, a recent<br>skin graft, massive edema or extreme<br>deformity of the leg.<br>On any neuropathy.<br>On extremities that are insensitive to pain.<br>Where increased venous or lymphatic return<br>is undesirable. | MUST NOT be used to treat the following<br>conditions: Persons with suspected, active or<br>untreated: deep vein thrombosis, ischemic<br>vascular disease, severe arteriosclerosis,<br>pulmonary edema,<br>severe congestive heart failure,<br>thrombophlebitis, or an active infection.<br>On the legs where cuffs would interfere with<br>the following conditions: vein ligation,<br>gangrene, dermatitis, open wounds, a recent<br>skin graft, massive edema or extreme<br>deformity of the leg.<br>On any neuropathy.<br>On extremities that are insensitive to pain.<br>Where increased venous or lymphatic return<br>is undesirable. | Identical |
| Target Population /<br>Intended Users | Patients who need venous return and<br>lymphedema treatment | Patients who need venous return and<br>lymphedema treatment | Identical |
| Where Used | Home, Hospital, Surgery Center, Altitude<br>travel, areas of limited mobility | Home, Hospital, Surgery Center, Altitude<br>travel, areas of limited mobility | Identical |
| Application | Non-invasive / external | Non-invasive / external | Identical |
| Portability | Portable, ambulant | Portable, ambulant | Identical |
| Basis of operation | Aids venous return by using cyclic,<br>intermittent, pneumatic pressure application<br>(inflation followed by deflation) to<br>compress the extremities | Aids venous return by using cyclic,<br>intermittent, pneumatic pressure application<br>(inflation followed by deflation) to compress<br>the extremities | Identical |
| Anatomical Site /<br>Location of treatment<br>application | Extremities | Leg | Identical or<br>Similar |
| System management | Microprocessor | Microprocessor | Identical |
| Pressure Source | Micro pump controlled by microprocessor | Micro pump controlled by microprocessor | Identical |
| Operating Modes | Preset and adjustable modes | Preset and adjustable modes | Identical |
| Working Pressure | Preset at 50 mmHg and adjustable from 20<br>- 80 mmHg | Preset at 50 mmHg and adjustable from 20 -<br>80 mmHg | Identical |
| Cycle Time | In the preset 50mmHg mode, each chamber<br>will inflate in sequence, starting at the foot | In the preset 50mmHg mode, each chamber<br>will inflate in sequence, starting at the foot | Identical |
| | the chambers reach the intended pressure<br>levels. All four chambers will then deflate | the chambers reach the intended pressure<br>levels. All four chambers will then deflate to | |
| | to the low pressure level. This cycle of | the low pressure level. This cycle of inflation | |
| | inflation and deflation will continue until | and deflation will continue until the device is | |
| | the device is turn off. | turn off. | |
| | In the adjustable 20 - 80 mmHg mode, the | In the adjustable 20 - 80 mmHg mode, the | |
| | pressure of each chamber could be adjusted | pressure of each chamber could be adjusted | |
| | first, and each chamber will inflate in<br>sequence, starting at the foot and working | first, and each chamber will inflate in<br>sequence, starting at the foot and working up | |
| | up toward the knee until all of the chambers | toward the knee until all of the chambers | |
| | reach the intended pressure levels. All the | reach the intended pressure levels. All the | |
| | chambers will then deflate to the low | chambers will then deflate to the low | |
| | pressure level. This cycle of inflation and | pressure level. This cycle of inflation and | |
| | deflation will continue until the device is | deflation will continue until the device is turn | |
| System diagnostics | turn off.<br>Audible and visual alarms prompt | off.<br>Audible and visual alarms prompt | Identical |
| | recognition of system faults…