Who is the manufacturer of NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPS?

Thermotek, Inc. filed the 510(k) submission for NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPS (K061866).

What is the FDA product code for NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPS?

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

What is the regulatory pathway for NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPS?

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

What are the predicate devices for NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPS?

Chattanooga Group, Inc. PresSsion S III (K942796); KCI PlexiPulse® All-in-1 System (K981311); Aircast VenaFlow System Disposable Cuffs (K023800); Bio Compression Systems BioComfort Garments (K043423); MicroTek Medical Holdings, Inc. Venodyne DVT Advantage Plus+ (K011318); Ormed Artrotherm Cryotherapy and Thermotherapy (K964799).

Who can help prepare an FDA 510(k) submission like NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPS

K061866 · Thermotek, Inc. · JOW · Aug 22, 2006 · Cardiovascular

Device Facts

Record ID	K061866
Device Name	NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPS
Applicant	Thermotek, Inc.
Product Code	JOW · Cardiovascular
Decision Date	Aug 22, 2006
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.5800
Device Class	Class 2
Attributes	Therapeutic, 3rd-Party Reviewed

Indications for Use

The NanoTherm and VascuTherm systems are new devices that are intended to function as intermittent, external pneumatic compression devices. The intended therapy of the device is to aid in the reduction and control of edema including lymphedema of the upper and lower extremities and venous stasis ulcers. The intended therapy of the device is to reduce the risk of the formation of deep venous thrombosis and aid blood flow back to the heart via lower extremity limb compression in addition to the intended uses of the NanoTherm device.

Device Story

NanoTherm and VascuTherm are intermittent, external pneumatic compression systems. NanoTherm provides compression and thermal therapy (chilled/heated fluid); VascuTherm adds an air-only DVT compression mode. Systems consist of a microprocessor-controlled pump unit and single-patient-use inflatable wraps. Used in clinical settings for non-ambulatory adults. Microprocessor monitors sensors for safety, triggering visual/audible alarms for malfunctions or overpressure. Therapy reduces edema, lymphedema, and DVT risk by enhancing blood flow and reducing compartmental pressures. Healthcare providers prescribe and oversee therapy, particularly for patients with sensory deficits, low blood pressure, or diabetes. Output allows clinicians to manage post-surgical/traumatic recovery and vascular conditions.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, comparison of technological characteristics, and performance specifications against legally marketed predicate devices.

Technological Characteristics

Microprocessor-controlled pneumatic pump; 110 VAC power. Thermal therapy range: 43°F–49°F (cold), 105°F (heat). Wraps: 200 Denier Nylon Oxford or DuPont Softesse medical fabric. Safety: high/low temperature alarms, malfunction alarms, pressure vent switch. Connectivity: standalone. Standards: UL 60601 Class II Type B, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2.

Indications for Use

Indicated for non-ambulatory adults for treatment of vascular/lymphatic insufficiency (CVI, venous stasis ulcers, post-mastectomy edema, chronic lymphedema), reduction of edema (burns, postoperative, ligament sprains), and localized thermal therapy (hot/cold) for post-traumatic/surgical conditions. VascuTherm is additionally indicated to decrease DVT risk, aid venous return, and assist healing of cutaneous ulcerations. Contraindicated for patients with CHF, DVT/PE, inflammatory phlebitis, pulmonary edema, arterial/venous occlusive disease, Raynaud's, or hypersensitivity to cold.

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

Chattanooga Group, Inc. PresSsion S III (K942796)
KCI PlexiPulse® All-in-1 System (K981311)
Aircast VenaFlow System Disposable Cuffs (K023800)
Bio Compression Systems BioComfort Garments (K043423)
MicroTek Medical Holdings, Inc. Venodyne DVT Advantage Plus+ (K011318)
Ormed Artrotherm Cryotherapy and Thermotherapy (K964799)

Submission Summary (Full Text)

{0}------------------------------------------------ KC61866 Page 1 of 7 # Section 5. 510(k) Summary AUG 2 2 2006 APPLICANT [As Required by 21 CFR 807.92 a(1)] Applicant: Address: Telephone Number: ThermoTek, Inc. 1454 Halsey Way Carrollton, TX 75007 972-242-3232 972-446-1195 (fax) Company Contact: Tony Quisenberry President June 21, 2006 Date: DEVICE NAME [As Required by 21 CFR 807.92 a(2)] Proprietary Name: NanoTherm™ and VascuTherm™ Common Name: Intermittent, External Pneumatic Compression Device Classification Name: Compressible Limb Sleeve (per 21 CFR section 870.5800) # IDENTIFICATION OF PREDICATE DEVICES [As Required by 21 CFR 807.92 a(3)] | • | Chattanooga Group, Inc. PresSsion S III | K942796 | |---|-----------------------------------------------------------------|---------------------------------------------------------------------| | • | KCI PlexiPulse® All-in-1 System | K981311 | | • | Aircast VenaFlow System Disposable Cuffs as bundled | K023800 | | • | Bio Compression Systems BioComfort Garments | K043423 | | • | MicroTek Medical Holdings, Inc. Venodyne DVT Advantage Plus+ | K011318 | | • | Ormed Artrotherm Cryotherapy and Thermotherapy | K964799 sited and currently exempt Class II, per 21 CFR 890.5720 | {1}------------------------------------------------ KC61866 Page 2 of 7 ### DEVICE DESCRIPTION [As Required by 21 CFR 807.92 a(4)] #### Intended Use The NanoTherm and VascuTherm systems are new devices that are intended to function as intermittent, external pneumatic compression devices. The intended therapy of the niconfiteen, envice is to aid in the reduction and control of edema including lymphedema of the upper and lower extremities and venous stasis ulcers. The intended therapy of the or the upper and were is to reduce the risk of the formation of deep venous thrombosis new Yasour nen a blood flow back to the heart via lower extremity limb compression in addition to the intended uses of the NanoTherm device. #### Physical Description The NanoTherm device is comprised of a reusable pump (NanoTherm unit) and various The Nation use inflatable wraps (NanoTherm Wraps). The VascuTherm device consists single patient use mixes of herm unit) and various single-patient use inflatable wraps (VascuTherm Wraps). The VascuTherm unit has additional equipment installed and specially designed wraps specifically for the preventive treatment of DVT. #### Therapy Modality Used I herapy modality Oba The NanoTherm unit thermal control therapy provides chilled fluid and heated fluid to the The Nano Fierin and themity therapy site to reduce pain and swelling and compresses the writinou on an one on an enormance and fluid transfer and treatment of edema and lymphedema. The VascuTherm unit contains a DVT mode that is not present on the NanoTherm unit. This therapy mode is for air-only DVT compression therapy using air-only DVT wraps. #### Safety Features Sancey Features The NanoTherm and VascuTherm systems utilize microprocessor control with multiple r he Nano Filent and vansafety and system functionality, and to provide consistent and Sensors to choure panolalities. Alarms are both visual on the unit display and audible. repeatable therapy modentially unsafe situation and to terminate therapy to Alarms are in place to detect a possible in the situations are listed in the risk and hazard analysis covered in Appendices 16.3.A and 16.3.B. ### STATEMENT OF INTENDED USE [As Required by 21 CFR 807.92 a(5)] #### Patient Population The NanoTherm and VascuTherm devices` intended patient population is a non-ambulatory adult. {2}------------------------------------------------ KC61866 Page 3 of 7 NanoTherm Indications: - Treatment of disorders associated with vascular or lymphatic insufficiency such as o . I reatment of disorders associated with rabonial ess ulcers, post-mastectomy edema and chronic lymphedema. - and chronic lymphedelha. Reduction of edema associated with soft tissue injuries such as burns, postoperative ■ edema, and ligament sprains. - edema, and figallent splains. Localized thermal therapy (hot or cold) for post traumatic and post surgical medical в and/or surgical conditions. ## NanoTherm Contraindications - Presumptive evidence of congestive heart failure 트 - Presumptive evidence of congesting deep vein thrombosis or pulmonary embolism 트 - Suspected/observed deep acute venal thrombosis (phlebothrombosis) 트 - Suspected/observed inflammatory phlebitis process 트 - Suspected/observed pulmonary edema l - Suspected/observed acute inflammations of the veins (thrombophlebitis) . - Suspected/observed decompensated cardiac insufficiency 트 - Suspected/observed arterial dysregulation 트 - Suspected/observed erysipelas ■ - Suspected/observed carcinoma and carcinoma metastasis in the affected extremity 트 - Suspected/observed decompensated hypertonia 보 - Suspected/observed acute inflammatory skin diseases or infection 트 - Suspected/observed venous or arterial occlusive disease . - Determine venous and lymphatic return is undesirable I - Suspected/observed patient has Raynaud's Disease I - Suspected/observed poor peripheral circulation b - Suspected/observed hypersensitivity to cold I - Patient therapy contact on extremity containing a fracture 트 - Extremities that are not sensitive to pain ■ VascuTherm Indications: - nerm indications. Treatment of disorders associated with vascular or lymphatic insufficiency such as ■ Treathent of disorders associated +1), venous stasis ulcers, post-mastectomy edema and chronic lymphedema. - and chrome fymphedema. Reduction of edema associated with soft tissue injuries such as burns, postoperative . edema, and ligament sprains. - edema, and figativent sprains. Localized thermal therapy (hot or cold) for post traumatic and post surgical medical .. and/or surgical conditions. - Decrease the risk of deep venous thrombosis (DVT). - Aids the blood flow back to the heart. . - Alds the brood frow back to the neat: Treat and assist healing of cutaneous ulceration (wounds), reduce would healing ■ Treat and assist healing of catalional (blood flow), reduce compartmental pressures, time, cimance arena (swelling), reduce the need for anticoagulant (blood thinning) medications. {3}------------------------------------------------ KC61866 Page 4 of 7 - Treat and assist healing of cutaneous ulceration (wounds), reduce would healing I time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications. ### VascuTherm Contraindications - Presumptive evidence of congestive heart failure 트 - Suspected/observed pre-existing deep vein thrombosis or pulmonary embolism 트 - Suspected/observed deep acute venal thrombosis (phlebothrombosis) 트 - Suspected/observed inflammatory phlebitis process 트 - Suspected/observed pulmonary edema 트 - Suspected/observed acute inflammations of the veins (thrombophlebitis) 트 - Suspected/observed decompensated cardiac insufficiency ■ - Suspected/observed arterial dysregulation 제 - Suspected/observed erysipelas 이 - Suspected/observed carcinoma and carcinoma metastasis in the affected extremity I - Suspected/observed decompensated hypertonia 1 - Suspected/observed acute inflammatory skin diseases or infection 트 - Suspected/observed venous or arterial occlusive disease 제 - Determine venous and lymphatic return is undesirable 트 - Suspected/observed patient has Raynaud's Disease 미 - Suspected/observed poor peripheral circulation 트 - Suspected/observed hypersensitivity to cold 비 - Patient therapy contact on extremity containing a fracture 트 - Extremities that are not sensitive to pain I The following patients must use the NanoTherm or VascuTherm therapy systems for t he forlowing ptact therapy under the supervision of a physician if they are: - Individuals with extremities not sensitive to pain 메 - Individuals with extremely low blood pressure . - Individuals with Raynaud's Disease I - Hypersensitive to cold I - Children - l Diabetics ### Differences in Indications Dirrerences in manoTherm and VascuTherm devices are the same as those for the predicate devices listed in the Tables 1, 3 and 5 below. {4}------------------------------------------------ K061866 Page 5 of 7 ## TECHNOLOGICAL CHARACTERISTICS [As Required by 21 CFR 807.92 a(6)] The NanoTherm and VascuTherm devices have the same performance characteristics as the predicate devices. The pneumatic control circuitry is a microprocessor-controlled system. Multiple safety The plicultiatio control one system including: high and low temperature alarms, alarms for unit malfunction situations, and system malfunction overpressure safety via a pressure vent switch. Power is supplied via 110 VAC line current. vent Switch. I ower is supplied the 110 is received in cooling from 43°F to 49° and to 105°F in heating mode. # Comparison of features and principles of operation between the NanoTherm and Comparison of teatures and the predicate devices per Section 510(k) of the Act. | Table 1. Summary of Edema/Lymphedema Therapy Modality Comparison for the Units | | | |--------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Parameter | NanoTherm and VascuTherm for edema/lymphedema only | Chatttanooga Group, Inc. PresSsion S III (K942796) | | Pump Pressure Range | 30 mm Hg. ±5 mm Hg. | 30-100 mm Hg. ±5 mm Hg. | | Default Pressure | 30 mm Hg. | User Selectable | | Cycle Time | Inflation: 20 seconds Deflation: 40 seconds | Inflation: 5-120 seconds Deflation: 5-60 seconds | | Indications for Use | Compression therapy is indicated for the following: Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post- mastectomy edema and chronic lymphedema. Reduction of edema associated with soft tissue injuries such as burns, postoperative edema, and ligament sprains. (K942796) | Compression therapy is indicated for the following: Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post- mastectomy edema and chronic lymphedema. Reduction of edema associated with soft tissue injuries such as burns, postoperative edema, and ligament sprains. Decrease the risk of deep venous thrombosis (DVT). | | UL Mark | UL 60601 Class II, Type B | Class I, Type BF | | CE Mark | IEC 60601-1 (safety) IEC 60601-1-1 (Emissions, Class A) IEC 60601-1-2 (Immunity) | Not known | na Therany Modality Comparison for the Units #### f Edema/Lymphedema Biocompatibility Comparison for the Wraps | Table 2. Summary of Edema/Lymphedema Biocompatibility Comparison | | | |------------------------------------------------------------------|--------------------------------------------|------------------------------------------------------------------| | Parameter | Therapy wraps for edema/lymphedema only | BioCompression Systems, Inc. BioComfort Garments (K043423) | | Material in Skin Contact | 200 Denier Nylon Oxford | 200 Denier Nylon Oxford | | Sterile/Non-Sterile | Sterile and Non-Sterile | Sterile and Non-Sterile | | Single Patient Use | Yes | Yes | {5}------------------------------------------------ K061866 Page 6 of 7 | Parameter | VascuTherm | Chatttanooga Group, Inc. PresSsion S III (K942796) | MicroTek Medical Venodyne DVT Advantage Plus+ (K011318) | KCI PlexiPulse All-in-1 System (K981311) | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Pump Pressure Range | 45-100 mm Hg. ±5 mm Hg. | 30-100 mm Hg. ±5 mm Hg. (calf therapy only) | 40-45 mm Hg. (calf and foot therapy) | 140-180 mm Hg. ±5 mm Hg. (foot therapy only) | | Default Pressure | 45 mm Hg. (calf) 100 mm Hg. (foot) | User Selectable | 45 mm Hg. | 160 mm Hg. (foot therapy only) | | Cycle Time | Inflation: 30 seconds Deflation: 30 seconds | Inflation: 5-120 seconds Deflation: 5-60 seconds | Inflation: 12 seconds Deflation: 48 seconds | Inflation: 1-5 seconds Deflation 20-60 seconds | | Indications for Use | Decrease the risk of deep venous thrombosis, DVT. (K942796, K011318, K981311) Aids the blood flow back to the heart. (K011318) Treat and assist healing of cutaneous ulceration (wounds), reduce would healing time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications. (K981311) | Compression therapy is indicated for the following: Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema and chronic lymphedema. Reduction of edema associated with soft tissue injuries such as burns, postoperative edema, and ligament sprains. Decrease the risk of deep venous thrombosis (DVT). | The Venodyne DVT Advantage model 620 is designed to compress the lower limbs aiding the blood flow back toward the heart to prevent deep vein thrombosis in patients at risk. | The Cowboy XV is intended for patients in the home who would benefit from increased blood flow to: Treat and assist healing of cutaneous ulceration (wounds), reduce would healing time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant medications (medications that thin the blood), and prevent deep venous thrombosis (DVT) (blood clots in deep veins). | | UL Mark | UL 60601 Class II, Type B | UL - Type BF, Class 1 | Not Known | UL | | CE Mark | IEC 60601-1 (safety) IEC 60601-1-1 (Emissions, Class A) IEC 60601-1-2 (Immunity) | Not Known | Yes | Not Known | #### of DVT Therany Modality Comparison for the Unit ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ . . {6}------------------------------------------------ KC61866 Page 7 of 7 | Table 4.Summary of DVT Biocom Parameter | VascuTherm air-only therapy wraps for DVT prevention only | Aircast Vena Flow Sterile Disposable Cuffs (K023800) | |--------------------------------------------|-----------------------------------------------------------------|------------------------------------------------------------| | Material in Skin Contact | DuPont Softesse® Medical Fabric (non-latex, non-woven) | DuPont Softesse® Medical Fabric (non-latex, non-woven) | | Sterile/Non-Sterile | Non-Sterile | Non-Sterile and Sterile | | Single Patient Use | Yes | Yes | # of DVT Biocompatibility Comparison for the Wraps # Table 5. Summary of Water Circulating Thermal Therapy | Parameter | NanoTherm and VascuTherm devices | Artrotherm Cryotherapy and Thermotherapy (K964799) | |---------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------| | Therapy Type | Heat/Cool | Heat/Cool | | Therapy Temperature Range | Heat: 105°F Cold: 43°F to 49°F | Heat: 122°F Cold: 43°F | | Indications for Use | Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions. (K964799) | Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions. | {7}------------------------------------------------ Image /page/7/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The seal is presented in black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 2 2 2006 ThermoTek, Inc. C/O Mr. Jay Kogoma Senior Staff Engineer 2307 East Aurora Road, Unit B7 Twinsburg, OH 44087 Re: K061866 K061866 Trade/Device Name: NanoTherm and VascuTherm Systems Trade/Device Name: Name 200 Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible limb sleeve Regulatory Class: Class II Product Code: JOW, ILO Dated: August 4, 2006 Received: August 7, 2006 Dear Mr. Kogoma: We have reviewed your Section 510(k) premarket notification of intent to market the device is We have reviewed your Section 5 IQ(k) premium in enwivelst (for the indications referenced above and have device is substantialy equivalent (for the indications referenced above and have determined the usevices marketed in interstate for use stated in the enclosure) to legally marketed in interstate for use stated in the enclosure) to legally market predical Device America Amendments, or to commerce prior to May 28, 1976, the enactment date of the Fedical Food, Drug, commerce prior to May 28, 1976, the enactment with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance with the provisions of the Fede devices that have been reclassified in accordance with the provisions of the Possion (PMA). and Cosmetic Act (Act) that do not require approval of a previsions of the Act. T and Cosmetic Act (Act) that do not require approval or a picularios approvisions of the Act. The You may, therefore, market the simply do recurements for annual registratio You may, therefore, market the Act include requirements for annual registration, listing of general controls provisions of the Act include requirements misbranding and general controls provisions of the Act include requirements to: Michile of Groups of the adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) nito either cities in especial estable on the line can may be subject to such additional controls. Existing major regulations affect may be subject to such additional controls. EXSthig inajor regalitation and more of the may be found in the Code of Federal Regulations, Title 21, Parts 800 to 898, In and be found in the Code of Federal Regulations, Title BT, Care of Federal Register. publish further announcements concerning your device in the Federal Register. {8}------------------------------------------------ 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, R. vichner Image /page/8/Picture/4 description: The image contains a handwritten symbol that appears to be a combination of curved and angular lines. The symbol is black and stands out against a white background. It is positioned on the left side of the image. The symbol is next to the letters 'E' and 'D'. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ # Indications for Use 510(k) Number (if known): _K061866 Device Name: NanoTherm________________________________________________________________________________________________________________________________________________________ Indications for Use: - Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema and chronic lymphedema. - Reduction of edema associated with soft tissue injuries such as burns, postoperative edema, and ligament sprains. - Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions. | Prescription Use | X | |-----------------------------|---| | (Part 21 CFR 801 Subpart D) | | AND/OR | Over-The-Counter Use | | |------------------------|--| | (21 CFR 801 Subpart C) | | - Device Name: VascuTherm ______________________________________________________________________________________________________________________________________________________ Indications for Use: - Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema and chronic lymphedema. - Reduction of edema associated with soft tissue injuries such as burns, postoperative edema, and ligament sprains. - Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions. - Decrease the risk of deep venous thrombosis (DVT). Aids the blood flow back to the heart. - Treat and assist healing of cutaneous ulceration (wounds), reduce would healing time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications. Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) mountine of CDRH, Office of Device Evaluation (ODE) Division Sign-Off) Division of Cardiovascular Devices Page 1 of 1 510(k) Number. K061866

NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPS

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