THERMO-THERAPY, MODELS TT-101, TT-201, AND TT-202

{0}------------------------------------------------ K011768 450 Houte 30, Imperial, PA 15126 (724) 695-1890 Fax (724) 695-1892 Toll Free No. 1-800-633-8080 Specialists in precise temperature control ## AUG - 3 2001 Page 6-1 510(K) Summary ## 510 (K) Summary We at Thermo-Electric Company believe our Thermo-Therapy products (Models TT-101, TTwe at Thermo-Ilectric Company oceloro to the equivalent sized Fluidotherapy models - with the 201, and 11-202) all Virtually lecitied to Fluidotherapy Model T-11, although the same in size exception that only 11-171 equiralent to Pally - not home use - and the cautions are so provided. This 510 (K) is being submitted by: ## Thermo-Electric Company 455 Route 30 Imperial, PA 15126 Telephone Number (724) 695-1890 Fax Number (724) 695-1892 Lawrence E. Madson, Jr. - June 1, 2001 Thermo-Electric Company is an Ohio Corporation having been in business since 1924 and is also The manufacture of many other products for the use in the professional physical and occupational therapy market. The substantially equivalent (SE) product to our Thermo-Therapy is 510 (K) K871802 and 510 (K) K896817 both product code LSB and commonly known as Fluidotherapy. The Fluidotherapy type devices describe a process where ground cellulose is held in animated The railoonetapy type do roos attrough a screen filter (often called the Fluidizing Bed) and held captive by a housing and flexible velcro tightening sleeves. This process then allows for a hand, wrist, foot, ankle, and on larger units, the lower leg to be immersed in the heated cellulose. The now fluidized cellulose gently and warmly massages the extremity resulting in improved blood circulation, wound healing, comfort, etc. Thermo-Electric's Thermo-Therapy devices have identical technology characteristics to that of Fluidotherapy. {1}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle, represented by three curved lines that suggest the bird's wings and body. Public Health Service AUG - 3 2001 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Lawrence E. Madson, Jr. Vice President Thermo-Electric Company 455 Route 30 Imperial, Pennsylvania 15126 Re: K011768 Ko11700 Trade/Device Name: Thermo-Therapy - Models TT-101, TT-201, and TT-202 Regulatory Class: Unclassified Product Code: LSB Dated: July 13, 2001 Received: July 25, 2001 Dear Mr. Madson: We have reviewed your Section 510(k) notification of intent to market the device referenced we have teviewed your becally of the is substantially equivalent (for the indications for use above and we nave determined the avedicate devices marketed in interstate commerce stated in the enclosure) to logally markets of the Medical Device Amendments, or to devices that provision in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (Act. The general controls provisions of the Act include requirements for annual provisions of the Act. "The general conanufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations (Fremarket Apploval), it may of subject to save as a legulations, Title 21, Parts 800 to 895. arreoung your at novelant determination assumes compliance with the Current Good A subscantaily equirements, as set forth in the Quality System Regulation (QS) for Manufacturing Practice requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to inspections, the Food and Drag realiting to result in regulatory action. In addition, FDA may publish comply with the GMT regaraters anyour device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might response to your premating of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {2}------------------------------------------------ Page 2 - Mr. Lawrence E. Madson, Jr. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nontication. The I Driving sification 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 and 11 you desire specific acrise diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, (2017) 594-1639. Traditional (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small miorination on your responsible free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours, illon for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Page 8-1 Indications for Use Statement (Revised July 11, 2001) 510 (k) Number (if known): ___________________________________________________________________________________________________________________________________________________ K 011768 Device Name: Thermo-Therapy - Models TT-101, TT-201, and TT-202 Indications for Use: Increase of Local Blood Circulation. Treatment of Range of Motion when combined with exercise. Treatment for minor pain and stiffness of non-rheumatoid arthritis. (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter-Use_ Tomlinson Mcraw (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number K011768 (Optional Format 1-2-96)