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Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL

Q: Who is the manufacturer of Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL?

Bio Compression Systems, Inc. filed the 510(k) submission for Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL (K210417).

Q: What is the FDA product code for Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL?

JOW. It is classified under 21 CFR 870.5800 as a Class 2 device in the Cardiovascular panel.

Q: What is the regulatory pathway for Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL?

510(k) clearance (submission type: Traditional).

K210417 · Bio Compression Systems, Inc. · JOW · May 14, 2021 · Cardiovascular

Device Facts

Record ID	K210417
Device Name	Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
Applicant	Bio Compression Systems, Inc.
Product Code	JOW · Cardiovascular
Decision Date	May 14, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.5800
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Bio Compression Systems' Sequential, pneumatic compression devices intended for either primary or adjunctive treatment of lymphedema, peripheral edema, venous insufficiency, and venous stasis ulcers. Sequential Circulators are also intended for the prophylaxis of deep vein thrombosis (DVT). Intended for use in a home or healthcare setting.

Device Story

Sequential pneumatic compression device consisting of segmented garment and pneumatic pump. Pump cyclically inflates garment chambers from distal to proximal to stimulate interstitial fluid and blood flow. Used in home or healthcare settings by patients or clinicians. Pump components include motor, air compressor, disc valves, and micro switch. Controlled via softkeys/LED (1000/2000 series) or touch screen LCD (4000 series). Features include adjustable cycle time, pressure, compliance meter, focus therapy, pause, and pre-therapy modes. Output is mechanical compression of limbs. Benefits include edema reduction and DVT prophylaxis.

Clinical Evidence

No clinical or animal studies were submitted or relied upon. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1 series), EMC (IEC 60601-1-2), functional verification (cycle/treatment time, pressure endpoint testing), and software validation.

Technological Characteristics

Pneumatic compression pump with motor, air compressor, and disc valve assembly. Garments: 200 Denier Nylon Oxford with 3 mil Polyurethane coating. Power: 120-240V, 50/60 Hz. Class II, Type BF applied part, IP21 ingress protection. Software class A (IEC 62304).

Indications for Use

Indicated for patients requiring treatment for lymphedema, peripheral edema, venous insufficiency, venous stasis ulcers, or DVT prophylaxis. Contraindicated for limb infections (e.g., cellulitis) without antibiotics, lymphangiosarcoma, suspected/confirmed DVT, inflammatory phlebitis, pulmonary embolism, or uncontrolled congestive heart failure.

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

Sequential Circulator models SC-3004-DL and SC-3008-DL (K142640)

Reference Devices

Related Devices

K181409 — Pressure Therapy System PT1003 · Xiamen Senyang Co., Ltd. · Feb 19, 2019
K151189 — Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System · Devon Medical Products · Sep 18, 2015
K120944 — KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER · Covidien · May 31, 2012
K102737 — KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER · Covidien, LLC · Oct 19, 2010
K013436 — NORMATEC PCD · Normatec, Inc. · Dec 21, 2001

Submission Summary (Full Text)

{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" followed by the words "U.S. Food & Drug Administration". May 14, 2021 Bio Compression Systems, Inc. Marc Somelofski Director of RA/QA 120 West Commercial Ave Moonachie, New Jersey 07074 ### Re: K210417 Trade/Device Name: Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: April 13, 2021 Received: April 15, 2021 ### Dear Marc Somelofski: 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 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 {1}------------------------------------------------ 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Nicole Gillette Assistant Director (Acting) 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K210417 Device Name Sequential Circulator models SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL Indications for Use (Describe) The Bio Compression Systems' Sequential, pneumatic compression devices intended for either primary or adjunctive treatment of lymphedema, peripheral edema, venous insufficiency, and venous stasis ulcers. Sequential Circulators are also intended for the prophylaxis of deep vein thrombosis (DVT). Intended for use in a home or healthcare setting. 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) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Bio Compression Systems Inc. The logo is blue and white. The word "BIO" is in large, bold letters, and the words "COMPRESSION SYSTEMS INC." are in smaller letters to the right of "BIO". There are vertical blue lines on either side of the text. # Section 5: Summary Date Prepared: April 13, 2021 ## I. SUBMITTER Bio Compression Systems, Inc. 120 West Commercial Avenue Moonachie, NJ 07074, USA Phone: +1-201-939-0716 Contact Person: Marc L. Somelofski ### II. DEVICE | Device Name | Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL | |------------------------|-----------------------------------------------------------------------------------------------| | Trade/Proprietary Name | Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL | | Common/Usual Name | Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL | | Classification Name | Compressible Limb Sleeve (21 CFR 870.5800) | | Product Code | JOW | | Class | Class II | ### III. PREDICATE DEVICE Sequential Circulator models SC-3004-DL and SC-3008-DL (K142640). Reference devices K043423, K122112, K131306, K150953, K171793, K182003, and K203178 are mentioned. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Bio Compression Systems Inc. The logo is in blue and consists of the word "BIO" in large, bold letters, followed by the words "COMPRESSION SYSTEMS INC." in smaller letters. The logo is flanked on both sides by a series of vertical bars of varying widths, also in blue. The bars give the logo a sense of depth and dimension. # IV. DEVICE DESCRIPTION Bio Compression Systems' Sequential Circulators are sequential pneumatic compression device which consists of a segmented pneumatic compression sleeve ("qarment") connected to a pneumatic compression pump ("pump"). The pump cyclically inflates the garment's segments ("chambers") in sequence from the distal end toward the trunk of the body. The inflation of the garment compresses the limb on which it is worn, stimulating the movement of interstitial fluid and blood flow. The core components of the pump are the motor, air compressor, disc valves, and micro switch. The air compressor generates air flow into a stationary disc valve. The motor moves a rotating disc valve. The geometry of the disc valve directs air flow and cyclically triggers the micro switch. The pump is controlled by softkeys and an LED display (models SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL) or by a touch screen LCD (models SC-4004-DL, SC-4008-DL). The device uses the Predicate Device's garments. | | Subject Device (K210417) | Predicate Device (K142640) | Comparison | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The Bio Compression Systems' Sequential Circulators are sequential, pneumatic compression devices intended for either primary or adjunctive treatment of lymphedema, peripheral edema, lipedema, venous insufficiency, and venous stasis ulcers. Sequential Circulators are also intended for the prophylaxis of deep vein thrombosis (DVT). Intended for use in a home or healthcare setting. | The Bio Compression Systems' SC-3008-DL, SC- 3004-DL, SC-3004DC-DL, and SC-2008-DL are sequential, pneumatic compression devices intended for either primary or adjunctive treatment of primary or secondary lymphedema. The devices are also intended for additional or alternate treatment of venous insufficiency and chronic venous stasis ulcers associated with venous insufficiency as well as general treatment for swelling of the extremities. The devices are intended for both home and hospital use | The addition of the lipedema and deep vein thrombosis prophylaxis indications is not a new use; devices in the category with similar characteristics and indications have been cleared for these indications (Reference Devices K131306, K182003, K203178). | # V. INDICATIONS FOR USE {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Bio Compression Systems Inc. The logo is in blue and white. The word "BIO" is in large, bold letters, with vertical bars on either side. To the right of "BIO" are the words "COMPRESSION SYSTEMS INC." in smaller letters. | | Subject Device (K210417) | Predicate Device (K142640) | Comparison | |-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contra - indications | Compression IS NOT recommended in the following conditions: • Infections in the limb, including cellulitis, without appropriate antibiotic coverage • The presence of lymphangiosarcoma • Suspicion or confirmation of the presence of Deep Vein Thrombosis (DVT) • Inflammatory phlebitis or episodes of pulmonary embolism • Congestive Heart Failure (CHF) unless controlled by medication • Other indications as identified by the treating physician | Compression IS NOT recommended in the following conditions: • Infections in the limb, including cellulitis, without appropriate antibiotic coverage • The presence of lymphangiosarcoma • Suspicion or confirmation of the presence of Deep Vein Thrombosis (DVT) • Inflammatory phlebitis or episodes of pulmonary embolism • Congestive Heart Failure (CHF) • Active cancer except for palliative care • Other indications as identified by the treating physician | The cancer contraindication and clarifies the CHF contraindication. Removal of the cancer contraindication does not suggest a new use. Devices in the category with similar characteristics and indications have been cleared without this contra-indication (Reference Devices K182003, K203178). | | Prescription/ over-the- counter use | Prescription | Prescription | Identical | #### TECHNOLOGICAL CHARACTERISTICS WITH VI. COMPARISON OF THE PREDICATE DEVICE | | Subject Device (K210417) | Predicate Device (K142640) | Comparison | |-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Operating Principle | Same as Predicate | An air compressor generates air flow in a stationery disc valve. A motor turns the top disc valve which directs air and trigger's a micro switch. | Identical | | Power Supply Rating | 120-240V, 50/60 Hz | 120 VAC, 60 Hz | Equivalent - the Subject Device and Predicate Device both connect to mains power. This is the same as other similar cleared devices (Reference Device K203178). | | | Subject Device (K210417) | Predicate Device (K142640) | Comparison | | Rated Input | 12VDC, 3A | 120 VAC, 0.5 A | Equivalent - the Subject Device has a lower input voltage. This is the same as other similar cleared devices (Reference Device K203178). | | Electrical Classification | Class II | Class II | Identical | | Applied Part | Type BF | Type BF | Identical | | Ingress Protection | IP21 | IP21 | Identical | | Cycle Time | • 1000 series: 60-120 seconds in 30- second increments • 2000/4000 series: 60-120 seconds in 15-second increments | 60 seconds | Similar - other devices in this category with the same operating principle have cycle times longer than 60 | | Treatment Time | Continuous or adjustable as follows: • 1000 series: 30-120 minutes adjustable in 30-minute increments • 2000/4000 series: 10-120 minutes in 5- minute increments | Continuous or 60 minutes | Equivalent | | Pressure Range | • 20-100 mmHg, adjustable in 5 mmHg increments • 10-120 mmHg, adjustable in 1 mmHg increments • 0-120 mmHg, adjustable in 1 mmHg increments | 0-120 mmHg, adjustable in 1 mmHg increments | Equivalent - Endpoint pressure values are not frequently used | | Pressure Accuracy | ± 20% | ± 20% | Identical | | Pressure Gradient (decrease/proximal chamber) | -1 mmHg (8-chamber models) or -2 mmHg (4-chamber models) | -1 mmHg | Equivalent - the Subject Device's 8-chamber models are identical and the 4- chamber models have the same total gradient as the Predicate Device's model SC- 3008-DI | | | Subject Device (K210417) | Predicate Device (K142640) | Comparison | | Software Safety Class (IEC 62304) | A | A | Identical | | Weight (4-chamber model) | • SC-1004-DL, SC- 2004-DL: 3.3 lbs. (1.5 kg) • SC-1008-DL, SC- 2008-DL: 3.65 lbs. (1.66 kg) • SC-4004-DL: 3.5 lbs. (1.59 kg) • SC-4008-DL: 3.85 lbs. (1.75 kg) | • SC-3004-DL: 5.65 lbs. (2.56 kg) • SC-3008-DL: 5.9 lbs. (2.68 kg) | Similar - The Subject Device's models are lighter | | Dimensions | • 1000 series: 4.5" x 11.75" x 7.75" (114 mm x 298 mm x 197 mm) • 2000/4000 series: 4.5" x 12" x 7.34" (114 mm x 304 mm x 186 mm) | 4.5" x 11.75" x 7.75" (114 mm x 298 mm x 197 mm) | Similar | | Compression Sleeves ("Garments") | Uses Predicate's garments | 200 Denier Nylon Oxford, coated with 3 mil of Polyurethane | Identical | | Features | • Adjustable Cycle Time • Adjustable Pressure • Compliance/Usage Meter • Focus Therapy Mode (2000/4000 series) • Pause • Pre-Therapy Mode (SC-4008-DL) • Timed Treatment • Individual Chamber Adjustment (4000 series) | • Adjustable Pressure • Compliance/ Usage Meter • Pre-Therapy Mode (SC-3008-DL) • Timed Treatment • Individual Chamber Adjustment | Minor differences in features. Subject Device: • has Adjustable Cycle Time - the range of which is comparable to the Predicate Device (60 seconds) and similar cleared devices (Reference Device K150953, 90 seconds). • has a Focus Therapy mode (2000/4000 series) which doubles inflation time on a group of garment chambers for the first 10 minutes - this is similar to the Predicate Device's Pre- Therapy mode which inflates the most distal group of garment chambers for the first 10 minutes • can pause treatment and treatment time - this is the same as other similar | Section 5: Summary Page 5-3 {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ | | 120 West Commercial Avenue, Moonachie, New Jersey 07074 | | | | | |--|---------------------------------------------------------|--|--|--|--| |--|---------------------------------------------------------|--|--|--|--| | Subject Device (K210417) | Predicate Device (K142640) | Comparison | |-----------------------------|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | cleared devices (Reference Device K203178). • 1000 and 2000 series lack Individual Chamber Adjustment feature - this is the same as other similar cleared devices (Reference Device K150953). | The Subject Device is based upon the Predicate Device and has the same technological characteristics with respect to design, materials used, and construction. - . Subject Device and Predicate Device have the same operating principle and use the same disc valve assembly for operation - . Components used in Subject and Predicate Devices are identical, the same material, or have the same specifications - The Predicate Device uses the Subject Device's compression garments. - . Subject Device and Predicate Device have the same or similar performance specifications The differences between the Subject Device and Predicate Device exist in similar cleared devices and do not raise any different questions of safety and/or effectiveness. - The Adjustable Cycle Time range is similar to cycle times for cleared devices with . the same Predicate as the Subject Device (Reference Device K150953) - . The lack of Individual Chamber Adjustment in 1000 and 2000 series is identical as cleared devices with the same Predicate as the Subject Device (Reference Device K150953) - The differences in rated input and power supply rating are equivalent, and the Pause feature is the same as similar cleared devices Reference Device (Reference Device K203178). # VII. PERFORMANCE DATA The following testing and performance data were provided in support of the substantial equivalence determination. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for Bio Compression Systems Inc. The logo is in blue and consists of the word "BIO" in large block letters, with the words "COMPRESSION SYSTEMS INC." stacked to the right of the "BIO". The logo is flanked on both sides by a series of vertical blue bars. ### Electrical safety and electromagnetic compatibility (EMC) - ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012 . - ANSI/AAMI HA60601-1-11:2015-08 ● - IEC 60601-1:2005/AMD1:2012 ● - IEC 60601-1-2:2014 ● - IEC 60601-1-6:2010/AMD1:2013 ● - IEC 60601-1-11:2015 ● ## Predicate Device routine acceptance tests conducted on Subject Device - Observation of continuous and timed operation ● - Pressure testing . - HiPot (dielectric withstand test) testing ● ## Functional verification and validation testing - Cycle time verification and validation - Treatment time verification and validation ● - Pressure setting endpoint testing ● - Operation to confirm all modes, settings, and mode/setting changes function as ● intended ## Comparative pressure testing of Subject and Predicate Device Individual Chamber Adjustment - The standard gradient setting ● - . Typical upper extremity settings - Typical fibrotic leg setting . ### Software Verification and Validation Testing Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices". The software for this device is considered as a "minor" level of concern and there are no cybersecurity risks. ### Clinical/Animal Studies Clinical/animal studies were not submitted, referenced, or relied on in this premarket notification submission for a determination of substantial equivalence. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for Bio Compression Systems Inc. The logo is primarily blue and white. The word "BIO" is in large, bold, blue letters, with a series of blue vertical bars on either side. To the right of "BIO" are the words "COMPRESSION SYSTEMS INC." in smaller, white letters. ### VIII. CONCLUSION The data included in this submission demonstrates that the Subject Device is substantially equivalent to the legally marketed Predicate Device and performs comparably to the Predicate Device that is currently marketed for the same intended use.

Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

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Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

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