Capiflo 5001

K222158 · K&L Distributing, Inc. · JOW · Jan 20, 2023 · Cardiovascular

Device Facts

• Record ID: K222158
• Device Name: Capiflo 5001
• Applicant: K&L Distributing, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Jan 20, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Capifio 5001 Deep Vein Thrombosis Prevention Therapy System is intended to be an easy to use portable system. prescribed by a physician, and used to help prevent the onset of Deep Vein Thrombosis (DVT) in patients by stimulating blood flow in the extremities (through the stimulation of muscle contractions). This device can be used in the home or clinical setting to: - Assist and aid in the prevention of Deep Vein Thrombosis (DVT). - As a prophylaxis for Deep Vein Thrombosis (DVT) by persons expecting to be stationary for long periods of time. - To increase blood circulation in the lower limbs. - Help reduce postoperative swelling and pain. - Cut down on wound healing time. - Capiflo can assist in the treatment of: - Chronic venous insufficiency - The reduction of edema in lower limbs - Venous stasis ulcers - Arterial leg ulcers - Diabetic leg ulcers - Stasis dermatitis

Device Story

Capiflo 5001 is a portable, physician-prescribed system for DVT prevention and circulation enhancement. Device stimulates muscle contractions in extremities to increase blood flow. Used in home or clinical settings. Patients or caregivers operate the system to aid in reducing postoperative swelling, pain, and wound healing time, and to manage conditions like venous stasis ulcers and chronic venous insufficiency. Output is mechanical stimulation of limbs; healthcare providers use this to manage venous health and prevent thrombus formation.

Technological Characteristics

Compressible limb sleeve system; portable design; intended for home or clinical use; prescription-only.

Indications for Use

Indicated for patients requiring DVT prophylaxis, including those stationary for long periods, and treatment of chronic venous insufficiency, lower limb edema, venous/arterial/diabetic leg ulcers, and stasis dermatitis. Prescription use only.

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.

Submission Summary (Full Text)

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January 20, 2023

K&L Distributing, Inc. Jody Hartlove Assistant 16034 US Highway 19 North Hudson, Florida 34667

Re: K222158

Trade/Device Name: Capiflo 5001 Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: July 11, 2022 Received: July 20, 2022

Dear Jody Hartlove:

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 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,

Eric E. Richardson -5 _ 2023.01.20 16:21:05 -05'00'

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

Enclosure

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## Indications for Use

510(k) Number (if known)

## K222158

Device Name Capiflo 5001

Indications for Use (Describe)

The Capifio 5001 Deep Vein Thrombosis Prevention Therapy System is intended to be an easy to use portable system. prescribed by a physician, and used to help prevent the onset of Deep Vein Thrombosis (DVT) in patients by stimulating blood flow in the extremities (through the stimulation of muscle contractions).

This device can be used in the home or clinical setting to:

- Assist and aid in the prevention of Deep Vein Thrombosis (DVT).
- As a prophylaxis for Deep Vein Thrombosis (DVT) by persons expecting to be stationary for long periods of time.
- To increase blood circulation in the lower limbs.
- Help reduce postoperative swelling and pain.
- Cut down on wound healing time.
- Capiflo can assist in the treatment of:
- Chronic venous insufficiency
- The reduction of edema in lower limbs
- Venous stasis ulcers
- Arterial leg ulcers
- Diabetic leg ulcers
- Stasis dermatitis

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

| <span></span> | <div> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
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