The DVTCare CA5 is intended to be a portable system that is prescribed by healthcare professionals to help prevent the onset of DVT in patients, by stimulating blood flow in the legs (simulating muscle contractions). Furthermore, the unit can be used as an aid in the prophylaxis for DVT by persons traveling, or those expecting to be stationary for long periods of time (> 4 hours). This device can also be used to: aid in the prevention of DVT, enhance blood circulation, diminish post-operative pain and swelling, reduce wound healing time, and aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency, and reduction of edema in the lower limbs.

Device Description

The subject 'DVTCare CA5' is a light weight, portable, prescriptive device intended to aid in prevention of Deep Vein Thrombosis (DVT) by helping to stimulate blood flow in the legs. This functionality is accomplished through the use of electronically controlled pump unit delivering a set amount of air to the leg cuffs that, in turn, compresses the calf(s) to aid blood flow out of the lower extremities. The pump control unit components are protectively housed in a plastic shell except the outer membrane switch (needed for user interface), 2 locking, plastic quick disconnects for air tube connection, and an external power supply input jack. The device is provided with non-serviceable battery to allow user portability, and an external power supply for mains connection.

During device operation, the pump unit provides air to the cuff through flexible plastic tubing, inflating it to a specified pressure (set by user or healthcare provider), to compress the lower limb, thus aiding venous return. Air pressure and delivery are monitored by a pressure transducer and integrated system software contained in the plastic control unit. Immediately after the pressure transducer detects that the cuff has achieved the set pressure, the cuff deflates to ambient pressure. This allows the blood flow to return to the limb. The device software ensures the cycle time is a minimum of 60 seconds (the is the length of time for one complete cycle on one cuff including fill time, exhaust, and relaxation time). This is done to prevent excessive stimulation of the limb.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the DVTCare CA5 device, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for the DVTCare CA5 are primarily demonstrated through comparisons to predicate devices and extensive non-clinical bench testing. The key performance characteristics are outlined in the comparison table and further supported by test reports.

Table of Acceptance Criteria and Reported Device Performance

Characteristic / Feature	Acceptance Criteria (Implied by Predicate & Design)	Reported Device Performance (Subject Device DVTCare CA5)	Notes
Application	Non-invasive / external	Non-invasive / external	Consistent with predicate devices.
Portability	Portable, ambulant	Portable, ambulant	Consistent with predicate devices.
Basis of Operation	Aids venous return by cyclic, intermittent, pneumatic pressure application to compress lower limb(s).	Aids venous return by cyclic, intermittent, pneumatic pressure application to compress lower limb(s).	Consistent with predicate devices.
Location of Treatment Application	Lower limb(s) (Calf)	Lower limb(s) (Calf)	Consistent with predicate devices.
System Management	Electronic, microprocessor controlled	Electronic, microprocessor controlled	Consistent with predicate devices.
Treatment Delivery	Uses electronic microprocessor and pneumatics to inflate and deflate bladder cuffs.	Uses electronic microprocessor and pneumatics to inflate and deflate bladder cuffs.	Consistent with predicate devices.
Pressure Source	Micropump controlled by electronic processor	Micropump controlled by electronic processor	Consistent with predicate devices.
Outlet Ports	Two (for K061125), Three (for K103187)	Two	Differs from one predicate (K103187) but within acceptable range as not raising new safety/effectiveness concerns.
Outlet Valves	One three-way valve with two vent valves (K061125); Three 3-way valves (K103187)	Two 2-way valves with one vent valve	Differs from both predicates but justified through non-clinical testing not to raise new safety/effectiveness concerns (Software Functions Verification Report highlighted, CA5 System Safety Testing Report).
Operating Modes	'Single leg' mode, 'Double leg' mode, and potentially auxiliary modes (K103187).	'Single leg' mode, 'Double leg' mode	Consistent with the core functionalities of predicates.
Working Pressure (User Adjustable)	20-40mmHg (K061125), 20-65mmHg (K103187)	20-50mmHg (user); 20-65mmHg (healthcare provider)	The default changed from 40mmHg (predicate K061125) to 50mmHg, and the upper limit for healthcare providers is consistent with predicate K103187. This change was validated (Software Functions Verification Report highlighted).
Inflation Time	10 seconds (K061125)	10 seconds	Consistent with at least one predicate.
Hold Time	0 seconds (K061125); ~3.5 seconds (K103187)	2 seconds	Differs from predicates (changed from 0s to 2s). This change was validated (Software Functional Requirements highlighted, Software Functions Verification Report highlighted, CA5 Predicate Testing).
Cycle Time	Preset 60 seconds, adjustable 60-75 seconds	Preset 60 seconds, adjustable 60-75 seconds	Consistent with predicate devices. Confirmed minimum cycle time of 60 seconds (fill, exhaust, relaxation).
System Diagnostics	Audible and visual alarms for system faults	Audible and visual alarms for system faults (and a self-diagnostic feature every half hour).	Consistent with predicates, with an added self-diagnostic feature (Software Functional Requirements highlighted, Software Functions Verification Report highlighted) to improve monitoring.
Battery Specifications	Ni-MH rechargeable battery	Li-Po rechargeable battery	Different type of battery than predicates, but validated not to raise new safety/effectiveness concerns (DVT Charge Parameters and Verification Report, Globtek battery UN38 3 TEST REPORT, EC DECLARATION EN62133 battery, Software Functions Verification Report highlighted, CA5 System Safety Testing Report, CA5 System EMC test report).
Power Requirement	Rechargeable battery and/or 110VAC	Rechargeable battery and/or 110VAC	Consistent with predicate devices. External power supply changed but validated (UL REPORT GTM21089, Software Functions Verification Report highlighted, CA5 System Safety Testing Report, CA5 System EMC test report).
Air Delivery	Via flexible plastic (PVC) tube(s) terminated with quick disconnect CPC fittings	Via flexible plastic (PVC) tube(s) terminated with quick disconnect CPC fittings	Consistent with predicate devices.
Leg Cuffs Material	PVC bladder covered with brushed Nylon (K061125); PVC bladder encased in soft, non-woven medical fabric (K103187)	PVC bladder covered with brushed Nylon	Consistent with at least one predicate.
Leg Cuff Sterility	Clean / non sterile	Clean / non sterile	Consistent with predicate devices.
Leg Cuff Usage	Single patient use	Single patient use	Consistent with predicate devices.
Software Control for Battery	N/A (for older battery types)	Modified to provide control for Lithium Ion battery	New feature due to battery change, validated (Software Functional Requirements highlighted).
Resettable Compliance Counter	N/A	Added for provider use to record hours of use	New feature, validated (Software Functional Requirements highlighted, Software Functions Verification Report highlighted).
Electrical Safety	Compliance to IEC/UL/CAN60601-1	Compliant (verified by third-party labs)	Demonstrated through non-clinical testing.
Electromagnetic Compatibility (EMC)	Compliance to IEC 60601-1-2	Compliant (verified by third-party labs)	Demonstrated through non-clinical testing.
Environmental Testing	(Implied by device type)	Performed (by third-party labs)	Demonstrated through non-clinical testing.
Vibration Integrity	Compliance to MIL-STD 810D, section 514.3-1	Compliant (verified by third-party labs)	Demonstrated through non-clinical testing specifically for portable units.
Case Material	ABS (predicate K061125)	ASA-PC	Changed from ABS, but validated not to raise new safety/effectiveness concerns (CA5 System Safety Testing Report, V0 material trans test 110512, CA5 Crush Test).

Study that Proves the Device Meets Acceptance Criteria

The document describes non-clinical bench testing as the primary method to prove the device meets acceptance criteria and demonstrates substantial equivalence to predicate devices. There is no mention of clinical studies involving human subjects.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size for Test Set: Not explicitly stated as a number of devices. The "test set" refers to the DVTCare CA5 device itself, which underwent a series of validation tests. It's implied that typical design verification and validation testing for a medical device involves one or more units of the final device.
Data Provenance: The testing was "in-house bench testing for design, software and performance validation" by the manufacturer (Ossur Americas Inc.), and "evaluated by third-party test laboratories" for specific standards (Electrical safety, EMC, Environmental, Vibration). This indicates a combination of internal and external validation. The country of origin for the data (beyond the company's location in Foothill Ranch, CA) is not specified further. The studies are by nature prospective as they are conducted on a manufactured device to verify its performance against design specifications and regulatory standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Number of Experts: Not specified.
Qualifications of Experts: The testing was performed by "third-party test laboratories" for compliance standards and by internal "design, software and performance validation" teams. The qualifications of these individuals are not detailed, but it's implied they are experts in electrical safety, EMC, environmental testing, vibration testing, and device design/software validation.

4. Adjudication Method for the Test Set

Not applicable. The tests mentioned are objective compliance tests against established standards (e.g., IEC, UL, MIL-STD) and internal design specifications. There's no subjective assessment requiring adjudication in the context described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study typically assesses human interpretation of medical images or data, which is not relevant for this device (a DVT prevention pump).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the testing described is primarily standalone performance of the device's hardware and software. The device itself (the pump unit) functions autonomously based on its programming to deliver pneumatic compression. Its performance is evaluated based on its ability to meet specified pressure, cycle time, hold time, safety, and operational parameters, without human intervention during the functional tests.

7. The type of ground truth used

The "ground truth" for the non-clinical testing consists of:

Regulatory Standards: IEC/UL/CAN60601-1 (Electrical safety), IEC 60601-1-2 (EMC), MIL-STD 810D, section 514.3-1 (Vibration integrity).
Design Specifications: Internal design requirements for working pressure, cycle time, hold time, battery performance, software functions, etc.
Predicate Device Characteristics: The performance parameters of the legally marketed predicate devices served as a benchmark for demonstrating substantial equivalence.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI models that require a "training set" of data.

9. How the ground truth for the training set was established

Not applicable, as no training set was used.

Summary

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Section VIII

VIII.A 510(k) Summary

MAY 0 2 2013

510(k) Number K130174

Date: Mar 11 2013

Submitter:

Ossur Americas Inc. 27051 Towne Centre Drive Foothill Ranch, CA 92610 Phone: 949-268-3185 Establishment Registration Number: 3003764610

Contact Person:

Ubaldo Anaya Quality Assurance Manager

Device name and classification:

Trade Name / Model: DVTCare CA5 Common or usual name: Compressible Limb Sleeve Device Classification Name: Compressible Limb Sleeve Class: II Product Code: JOW Regulation Number: 21 CFR 870.5800

Predicate Devices:

i. DVTCare CA5, Doctors Orders (K061125), Acquired by Ossur Americas
TriplePlay-VT Vascular Therapy System TPVT-01, Wildcat Medical Inc (K103187) ii.

Device Description:

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Intended Use / Indications for Use:

The subject DVTcare CA5 is intended to be a portable system that is prescribed by healthcare professionals to help prevent the onset of DVT in patients, by stimulating blood flow in the legs (simulating muscle contractions). Furthermore, the unit can be used as an aid in the prophylaxis for DVT by persons traveling, or those expecting to be stationary for long periods of time (> 4 hours). This device can also be used to: aid in the prevention of DVT, enhance blood circulation, diminish post-operative pain and swelling, reduce wound healing time, and aid in the treatment and healing of stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency, and reduction of edema in the lower limbs.

Technological Characteristics and comparison with predicates:

The intended use of the subject 'DVTCare CA5' is same as the intended use of the predicates DVTCare CA5 (K061125) and TriplePlay-VT (K103187). The fundamental technology of the proposed device is also same as that of the predicates. A comparison of the main characteristics and features of these devices is provided as follows:

	DVTCare CA5	DVTCare CA5	TriplePlay-VT VascularTherapy System, TPVT-01
	Subject Device(Ossur Americas, Inc.)	Predicate K061125(Össur Americas)	Predicate K103187(Wildcat Medical Inc.)
Characteristics/ Features
Application	Non-invasive / external	Non-invasive / external	Non-invasive / external
Portability	Portable, ambulant	Portable, ambulant	Portable, ambulant
Basis ofoperation	Aids venous return byusing cyclic, intermittent,pneumatic pressureapplication (inflationfollowed by deflation) tocompress the lowerlimb(s).	Aids venous return byusing cyclic, intermittent,pneumatic pressureapplication (inflationfollowed by deflation) tocompress the lowerlimb(s).	Aids venous return byusing cyclic, intermittent,pneumatic pressureapplication (inflationfollowed by deflation) tocompress the lowerlimb(s).
	DVTCare CA5	DVTCare CA5	TriplePlay-VT VascularTherapy System, TPVT-01
Characteristics/ Features	Subject Device(Ossur Americas, Inc.)	Predicate K061125(Össur Americas)	Predicate K103187(Wildcat Medical Inc.)
Location oftreatmentapplication	Lower limb(s) (Calf)	Lower limb(s) (Calf)	Lower limb(s) (Calf)
Systemmanagement	Electronic,microprocessor controlled	Electronic,microprocessor controlled	Electronic,microprocessor controlled
Treatmentdelivery	Uses electronicmicroprocessor andpneumatics to inflate anddeflate bladder cuffs toachieve compressiontherapy	Uses electronicmicroprocessor andpneumatics to inflate anddeflate bladder cuffs toachieve compressiontherapy	Uses electronicmicroprocessor andpneumatics to inflate anddeflate bladder cuffs toachieve compressiontherapy
Pressure Source	Micropump controlled byelectronic processor	Micropump controlled byelectronic processor	Micropump controlled byelectronic processor
Outlet ports	Two	Two	Three
Outlet valves	Two 2-way valves withone vent valve	One three-way valve withtwo vent valves	Three 3-way valves
OperatingModes	• 'Single leg' mode• 'Double leg' mode	• 'Single leg' mode• 'Double leg' mode	• Leg 1• Leg 2• Auxiliary• Leg 1+auxiliary• Leg 2+auxiliary
WorkingPressure	Single and double legmodes are preset at50mmHg; and adjustableby user between 20-50mmHg,	Single and double legmodes are preset at40mmHg; and adjustableby user between 20-40mmHg.	Leg 1 and Leg 2 modesare preset at 50mmHg;and adjustable between20-65mmHgAuxiliary modes arepreset at 35mmHg; andadjustable between 20-50mmHg.
	Note: The HealthcareProvider can adjustpressure range from 20-65mmHg for both modes,if so prescribed.	Note: The HealthcareProvider can adjustpressure range from 20-65mmHg for both modes,if so prescribed.
Inflation time	10 seconds	10 seconds	Not Specified
	DVTCare CA5	DVTCare CA5	TriplePlay-VT VascularTherapy System, TPVT-01
	Subject Device(Ossur Americas, Inc.)	Predicate K061125(Össur Americas)	Predicate K103187(Wildcat Medical Inc.)
Characteristics/ Features	Hold Time	2 seconds	0 second	3.5 seconds(approximately)Note: Although theTriplePlay-VT usermanual does not specifythe 'hold-time'; in-housetesting by Ossur showedthe hold-time as 3.5seconds (approximately)
	Cycle time(One inflationand deflationper limb)	Preset at 60 seconds,Adjustable between 60-75seconds	Preset at 60 seconds,Adjustable between 60and 75 seconds.	Preset at 60 seconds.Adjustable between 60-70seconds
	Systemdiagnostics	Audible and visual alarmsprompt recognition ofsystem faults	Audible and visual alarmsprompt recognition ofsystem faults	Audible and visual alarmsprompt recognition ofsystem faults
	BatterySpecifications	7.4V, 1.8Ah, Li-Porechargeable battery	6V, 1.8Ah, Ni-MHrechargeable battery	6V, 2.0 Ah, Ni-MHrechargeable battery
	PowerRequirement	Rechargeable batteryand/or 110VAC	Rechargeable batteryand/or 110VAC	Rechargeable batteryand/or 110VAC
	Air deliveryfrom pump tocuff bladder	Via flexible plastic (PVC)tube(s) terminated withquick disconnect CPCfittings	Via flexible plastic (PVC)tube(s) terminated withquick disconnect CPCfittings	Via flexible plastic airtubes with locking / quickdisconnect air ports
	Leg cuffs(garments)material	PVC bladder covered withbrushed Nylon	PVC bladder covered withbrushed Nylon	PVC bladder encased in asoft, non-woven medicalfabric made fromcommon sponge material
	Leg cuff Sterile/ Not Sterile	Clean / non sterile	Clean / non sterile	Clean / non sterile
	Leg cuff usage	Single patient use	Single patient use	Single patient use

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Like the predicates, the subject device uses intermittent, pneumatic compression to simulate muscle contractions in the legs aiding the return of venous flow. The compression is achieved by air delivery, through flexible plastic tubing that are terminated with CPC quick lock connectors, to inflatable cuffs/bladders that are wrapped around the limb(s) to transmit the pneumatic force to the leg. The air delivery is controlled by a microprocessor controlled pump and valve system. The specifications of the proposed device (such as working pressure, cycle

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time and hold-time) are also comparable to the identified predicates. Like the predicates, the proposed 'DVTCare CA5' includes audible and visual alarms for system monitoring and fault recognition. Like the predicates, the proposed device also incorporates rechargeable batteries enabling the unit to be portable; and is offered with an external power supply for connection to mains supply (for normal operation and battery recharging). The difference in type of battery between the subject device (Li-PO battery) and the predicate devices (Ni-MH battery), different configuration of outlet valves and slight difference in appearance do not raise any new concerns of safety or effectiveness.

Non-Clinical Testing

The 'DVTCare CA5' has been subjected to extensive in-house bench testing for design. software and performance validation. Moreover, the device was also evaluated by third party test laboratories for compliance to Electrical safety (IEC/UL/CAN60601-1) and Electromagnetic Compatibility (IEC 60601-1-2) and Environmental testing. Being a portable unit, the DVTCare CA5 was also tested to standard MIL-STD 810D, section 514.3-1 for Vibration integrity. The results from these non-clinical tests demonstrated that the proposed DVTCare CA5 meets design. safety and performance requirements; and does not raise any new concerns of safety and effectiveness.

Design Change	Validation Document
Upgrade from NiMH batteries to Lithium Ion batteries.	DVT Charge Parameters and Verification ReportGlobtek battery UN38 3 TEST REPORTEC DECLARATION EN62133 batterySoftware Functions Verification Report highlightedCA5 System Safety Testing ReportCA5 System EMC test reportCA5 Shelf Life TestCA5 PCB Verification Report
Changes in the external power supply.	UL REPORT GTM21089Software Functions Verification Report highlightedCA5 System Safety Testing ReportCA5 System EMC test report
The single 3-way outlet valve with two vent valves has been replaced by two 2-way fill valves with one common vent valve.	Software Functions Verification Report highlightedCA5 System Safety Testing Report
Case material changed from ABS to ASA-PC.	CA5 System Safety Testing ReportV0 material trans test 110512CA5 Crush Test
Software has been modified to provide control for the Lithium Ion battery.	Software Functional Requirements highlighted

The list of Design Changes and the corresponding Validation Documents are listed below. The location of each Test Report can be found in this in the Cover Letter, Section IV.B.

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Default pressure setting for both 'single-leg' and 'double-leg' modes has changedfrom 40mmHg to 50mmHg.	Software Functions Verification Reporthighlighted
The hold-time specification for bothmodes has changed from 0 seconds to 2seconds before deflation.	Software Functional Requirements highlightedSoftware Functions Verification ReporthighlightedCA5 Predicate Testing
Self-diagnostic feature added to verifyproper operation every half hour duringuse.	Software Functional Requirements highlightedSoftware Functions Verification Reporthighlighted
Resettable Compliance Counter added forprovider use to record number of hoursuse by each patient.	Software Functional Requirements highlightedSoftware Functions Verification Reporthighlighted

Conclusion:

Based on validation testing, compliance to voluntary standards and non-clinical bench testing information provided in the submission; the proposed 'DVTCare CA5' is substantially equivalent to the predicate devices, and does not raise any new concerns of safety of effectiveness. Therefore, the proposed device is substantially equivalent to the referenced predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 2, 2013

Ossur Americas Inc. c/o Mr. Ubaldo Anaya Quality Assurance Manager 27051 Towne Center Drive Foothill Ranch, CA 92610

Re: K130174

Trade/Device Name: DVTCare CA5 Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: March 14, 2013 Received: March 15, 2013

Dear Mr. Anaya:

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. 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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Page 2 - Mr. Mark Job

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Bram D. Zuckerman

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section VII

VII.C Indications for Use

510(k) Number (if known): K130174

Device Name: DVTCare CA5

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bram D. Zuckerman 2013.05.02 16:33

VII.C - 1

Regulation Number and Section

§ 870.5800 Compressible limb sleeve.

(a)
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.(b)
Classification. Class II (performance standards).