← Product Code [DWL](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/DWL) · K061411 # TORBOT VASCULAR COMPRESSION GARMENTS (K061411) _Torbut Group, Inc. · DWL · Oct 18, 2006 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/DWL/K061411 ## Device Facts - **Applicant:** Torbut Group, Inc. - **Product Code:** [DWL](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/DWL.md) - **Decision Date:** Oct 18, 2006 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5780 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for Use Torbot Vascular Compression Garments are intended to be used to apply pressure to the extremity and are indicated for use in the management of pooling of blood and/or lymphedema. ## Device Story Torbot Vascular Compression Garments are custom and ready-to-wear elastic garments designed to apply controlled graduated pressure to extremities. Fabric consists of nylon and spandex. Device functions by applying circumferential pressure via elastic yarns to reduce capillary leakage and improve capillary and lymphatic drainage/absorption. Used to manage edema and lymphedema. No electronic components, software, or automated processing involved. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Medical support stocking; nylon and spandex fabric; circumferential graduated compression via elastic yarns; non-powered; manual application. ## Regulatory Identification Medical support stocking to prevent the pooling of blood in the legs: A medical support stocking to prevent the pooling of blood in the legs is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for use in the prevention of pooling of blood in the leg. Medical support stocking for general medical purposes: A medical support stocking for general medical purposes is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for medical purposes other than the prevention of pooling of blood in the leg. ## Special Controls *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.(b) *Medical support stocking for general medical purposes* —(1)*Identification.* A medical support stocking for general medical purposes is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for medical purposes other than the prevention of pooling of blood in the leg.(2) *Classification.* Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter. ## Predicate Devices - Jobst Custom Compression Garments ([K925154](/device/K925154.md)) - Jobst Elvarex Compression Garments ([K963573](/device/K963573.md)) - Jobst Ready-To-Wear Arm Sleeves ([K991570](/device/K991570.md)) - D.R. Medical Controlled Pressure Garments ([K001300](/device/K001300.md)) - Dr. Emily Iker's DM Sleeve ([K021102](/device/K021102.md)) - Jobst Ready-To-Wear Gauntlet ([K013852](/device/K013852.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ ## OCT 1 8 2006 ## Torbot Group, Inc., Jobskin Division 510(k) Summary ## I. General Information on Submitter | Name: | Torbot Group, Inc., Jobskin Division | |------------|--------------------------------------| | Address: | 653 Miami Street
Toledo, OH 43605 | | Telephone: | (419) 724-1475 | Fax: (419) 724-1476 E-mail: greg.johnson@torbot.com Name of Contact Person: Greg Johnson Date Summary Prepared: May 16, 2006 ### II. General Information on Device Trade name: Torbot Vascular Compression Garments Classification Name: Medical Support Stocking #### III. Predicate Devices Torbot Vascular Compression Garments are substantially equivalent to the following devices: - Jobst Custom Compression Garments K925154 . - Jobst Elvarex Compression Garments K963573 . - Jobst Ready-To-Wear Arm Sleeves K991570 . - D.R. Medical Controlled Pressure Garments K001300 . - Dr. Emily Iker's DM Sleeve K021102 . - . Jobst Ready-To-Wear Gauntlet K013852 {1}------------------------------------------------ ## IV. Description of the Device Torbot Vascular Compression Garments, custom and ready-to-wear, help to prevent pooling of blood and fluid in the extremities by applying controlled graduated pressure. The fabric used is comprised of nylon and spandex which is used in the predicate devices. K061411 #### V. Intended Use Torbot Vascular Compression Garments are intended to be used to apply pressure to the extremity and are indicated for use in the management of pooling of blood and/or lymphedema. ### VI. Technological Characteristics of Device Compared to Predicate Device Compression for the Torbot Vascular Garments, as well as all the predicate devices, is provided by elastic yarns that act circumferentially on the extremity. The gradient compression present in these products helps reduce capillary leakage and improve capillary and lymphatic drainage and/or absorption. Consequently, they can be used to manage the same indications, i.e. edema and lymphedema. Greg Johnson General Manager Torbot Group, Inc., Jobskin Division {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Torbot Group, Incorporated Mr. Greg Johnson General Manager Jobskin Division 653 Miami Street Toledo, Ohio 43605 ## OCT 1 8 2006 Re: K061411 Trade/Device Name: Torbot Vascular Compression Garment Regulation Number: 880.5780 Regulation Name: Medical Support Stocking Regulatory Class: II Product Code: DWL Dated: August 14, 2006 Received: August 14, 2006 Dear Mr. Johnson: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations offecting 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 Ederal Register. {3}------------------------------------------------ Page 2 - Mr. Johnson 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) 276-0115. 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. Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ K061411 # Indications for Use 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ Device Name: Torbot Vascular Compression Garment Indications For Use: Torbot Vascular Compression Garments are intended to be used to apply pressure to the extremity and are indicated for use in the management of pooling of blood and/or lymphedema. 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) hle for Aow 10/17/2002 ം Anesthesiology, General Hospital on Control, Dental Devices Page 1 of 1 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/DWL/K061411](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/DWL/K061411) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com