Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and recognizable, and it is often used to represent the U.S. Department of Health & Human Services. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 30, 2016 STL International, Inc. % Korina Akhondzadeh Regulatory Consultant to STL International, Inc. Kara & Associates 6965 El Camino Real Suite 105-428 Carlsbad, California 92009 Re: K162702 Trade/Device Name: Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table Regulation Number: 21 CFR 888.5850 Regulation Name: Nonpowered Orthopedic Traction Apparatus and Accessories Regulatory Class: Class I Product Code: HST Dated: December 02, 2016 Received: December 05, 2016 Dear Korina Akhondzadeh: 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. 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 {1}------------------------------------------------ Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely. # Michael J.Hoffmann -S for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K162702 Device Name Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table ### Indications for Use (Describe) Teeter Decompression Devices are multiple user, reusable devices for home use, intended to provide traction to the spine while stretching the para-spinal muscles and soft tissues. The devices provide non-powered traction and are meant for use by adults. Use of the Teeter Decompression Devices is indicated for the following conditions: back pain, muscle tension, degenerative disc disease, spinal degenerative joint disease, spinal stenosis, herniated disc, spinal curvature due to tight muscles, sciatica, muscle spasm, and facet syndrome. Type of Use (Select one or both, as applicable)Prescription Use (Part 21 CFR 801 Subpart D) |X | 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 Teeter. The logo consists of a stylized letter "T" above the word "TEETER" in a sans-serif font. The "T" is made up of three triangles in different shades of blue and gray. The word "TEETER" is in a gray color. ## 510(k) Summary — K162702 This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92. | SUBMITTER | STL International, Inc.<br>9902 162nd Street, Court E<br>Puyallup, WA 98375<br>Tel: (253) 200-6119<br>Fax: (253) 840-5757 | |------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact:<br>Email: | Rylie Teeter Leier, CEO<br>rylie@teeter.com | | Official Correspondent | Korina A. Akhondzadeh<br>KARA & Associates (Regulatory Consultant to STL International, Inc.)<br>6965 El Camino Real, Suite 105-428<br>Carlsbad, CA 92009<br>Tel: 760-798-9642<br>Fax: 760-798-9643 | | Email | korina@kara2a.com | - Date Prepared: December 29, 2016 #### II. DEVICE | Device Name: | Teeter Decompression Devices | |----------------------|-----------------------------------------------------------| | Common/Usual Name: | Apparatus, Traction, Non-Powered | | Regulation: | 21 CFR 888.5850 | | Classification Name: | Nonpowered Orthopedic Traction Apparatus and Accessories | | Product Code: | HST | | Class: | I | #### lll. PREDICATE DEVICE This predicate device has not been subject to a recall. #### DEVICE DESCRIPTION IV. Teeter's decompression devices are designed to decompress the spine and stretch paraspinal soft tissues. The devices are non-powered, external (non-invasive) and usercontrolled. Decompression is accomplished in various ways depending on the model within the Teeter product family. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for the company Teeter. The logo consists of a stylized letter "T" above the word "TEETER" in a sans-serif font. The "T" is made up of three triangles, with the top triangle in teal, the middle triangle in gray, and the bottom triangle in light blue. The word "TEETER" is in gray. version type devices, which are illustrated below, decompress the spinal region with the weight of the upper body, (angle only applies to the manual table, the others only offer full inversion – so variable loads are not an option) Manual Inversion Table - Supporting the user at the ankles, the device enables the user to rotate into the inverted position and allows the user to maintain a relaxed state as their body weight combined with the downward force of gravity creates progressive traction, decompressing each joint by the same weight that compresses it while upright. The user is able to predetermine or stop at their chosen degree of rotation, allowing increasing stretching intensity as the angle of inversion advances. Image /page/4/Picture/3 description: In the image, a woman is using an inversion table. The woman is upside down with her feet secured in the ankle clamps. The inversion table is made of metal and has a padded backrest. The woman is wearing a blue tank top and gray leggings. Manual Inversion Table Gravity Boots - Supporting the user at the ankles, the device enables the user to hang in the inverted position, keeping the user relaxed while their body weight combined with the downward force of gravity creates progressive traction, decompressing each joint by the same weight that compresses it while upright. Image /page/4/Picture/6 description: In the image, a man is hanging upside down from an inversion table. The man is wearing a blue shirt and black shorts. He is smiling and looking at the camera. The inversion table is black and has blue padding around the ankles. The background is a white wall and a wooden door frame. Gravity Boots Forward Rotation Decompression Device - The user leans over a foam lap pad, supported at their upper thighs, to rotate forward on the device into an inverted position while bending the knees behind a roller for support. The lap pad and foam rollers provides a contact support, holding the user in the inverted position. The hips and knees {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for the company Teeter. The logo consists of a stylized letter "T" above the word "TEETER" in a bold, sans-serif font. The "T" is made up of two triangles, one in a darker shade of blue and the other in a lighter shade of blue. 90 degrees, placing the body in a position that flattens the lumbar curve, increasing muscle relaxation and decompression of the spine. Image /page/5/Picture/2 description: In the image, a man is using an ab exercise machine. The man is positioned upside down with his legs secured by pads. He is holding onto handles for support. The machine is made of metal and has a padded seat. Forward Rotation Decompression Device The manual traction devices, which are illustrated below, apply decompression to the spinal region by applying force with the bilateral upper extremities on the device's handlebars while the user's legs are secure and stationary. Portable Decompression Device - While seated on a flat surface, the user positions the device so the left and right thigh contacts align with upper-most thigh area and the foam roller contacts are behind the knees. The user reclines into the supine position, with knees and hips at 90°, flattening the lumbar curve to increase muscle relaxation and decompression of the lumbar spine once the device is utilized. The contacts provide leverage at the front and back of the thighs so that when the user pushes with their hands on the handles toward the feet, straightening their arms and applying selfcontrolled traction force to decompress the lumbar and mid-spine. Image /page/5/Picture/6 description: In the image, a woman is lying on her back while using a piece of exercise equipment. Her legs are bent at the knees, and her feet are resting on a chair. The exercise equipment is positioned between her legs and is being held in place by her hands. The woman is wearing a light green tank top and black shorts. She is looking up at the ceiling. Portable Decompression Device Horizontal Decompression Device - Laying in the supine position with knees bent at 90°, with supports under the armpits and behind the knees, the user pushes with their hands on the handles toward the feet. This causes the device to separate at the mid-point, pushing against the knees to pull the lower body away from the head and deliver traction to the lumbar and mid-spine. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Teeter. The logo consists of the word "TEETER" in a bold, sans-serif font, with a stylized triangular shape above it. The triangular shape is divided into three sections, with the top section being a darker teal color, the middle section being gray, and the bottom section being a lighter teal color. The word "TEETER" is in a gray color. Image /page/6/Picture/1 description: The image shows a blue and black Teeter FreeStep recumbent cross trainer. The machine has a padded seat and foot platforms. The machine is designed to provide a low-impact workout. Horizontal Depression Table All Teeter Decompression Devices are made of rigid, powder coated steel, plastic and foam, requiring little or no regular maintenance and allowing for easy product care. The devices allow the user to apply traction and control the force without use of mechanical weights, pulleys or weights. #### V. INDICATIONS FOR USE Teeter Decompression Devices are multiple user, reusable devices for home use, intended to provide traction to the spine while stretching the para-spinal muscles and soft tissues. The devices provide non-powered traction and are meant for use by adults. Use of the Teeter Decompression Devices is indicated for the following conditions: back pain, muscle tension, degenerative disc disease, spinal degenerative joint disease, spinal stenosis, herniated disc, spinal curvature due to tight muscles, sciatica, muscle spasm, and facet syndrome. Type of Use: Over-the-Counter Use ## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE Both the Teeter Decompression Devices and the predicate Lo-Bak TRAX are non-powered traction devices used to provide traction to the lumbar spine while stretching the para-spinal muscle and soft tissues. Refer to the following table for comparison of the technological characteristics with the Teeter Decompression Devices and the predicate. | Characteristic | Teeter Decompression Devices | | | | | | |----------------------------------------|----------------------------------|-------------------------------------|------------------------------------------------|----------------------------------------------|-----------------------------------|------------------------------------------| | | Manual<br>Inversion<br>Table | Gavity<br>Boots | Forward<br>Rotation<br>Decompression<br>Device | Portable<br>Decompression<br>Device | Horizontal<br>Depression<br>Table | Lo-Bak<br>TRAX<br>(Predicate)<br>K110858 | | Traction Type | Non-<br>Power | Non-<br>Power | Non-Power | Non-Power | Non-Power | Non-Power | | Product Type | Inversion | Inversion | Inversion | Manual | Manual | Manual | | Treatment<br>Position | Inverted at<br>various<br>angles | Inverted<br>at<br>various<br>angles | Inverted at<br>various angles | Supine | Supine | Supine | | Method of<br>generating<br>decompress- | Gravity<br>and<br>weight of | Gravity<br>and<br>weight of | Gravity and<br>weight of upper<br>body | Upper bilateral<br>extremities with<br>lower | Upper<br>bilateral<br>extremities | Upper<br>bilateral<br>extremities | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for the company "TEETER". The logo consists of a stylized letter "T" above the company name. The "T" is formed by two triangles, one in a dark teal color and the other in gray. The company name "TEETER" is written in a bold, sans-serif font in a dark color. | Characteristic | Teeter Decompression Devices | | | | | | |----------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------|-------------------------------------------------|-------------------------------------------------------|-------------------------------------------------------| | | Manual<br>Inversion<br>Table | Gavity<br>Boots | Forward<br>Rotation<br>Decompression<br>Device | Portable<br>Decompression<br>Device | Horizontal<br>Depression<br>Table | Lo-Bak<br>TRAX<br>(Predicate)<br>K110858 | | sion force | upper<br>body | upper<br>body | | extremities<br>secure and<br>stationary | with lower<br>extremities<br>secure and<br>stationary | with lower<br>extremities<br>secure and<br>stationary | | Amount of<br>force applied | Variable -<br>Based on<br>upper<br>body<br>weight<br>and angle<br>of<br>inversion | Variable<br>- Based<br>on upper<br>body<br>weight<br>and<br>angle of<br>inversion | Variable -<br>Based on<br>upper body<br>weight and<br>angle of<br>inversion | Variable -<br>Based on force<br>exerted by user | Variable -<br>Based on<br>force<br>exerted by<br>user | Variable -<br>Based on<br>force<br>exerted by<br>user | | Frame<br>construction | Powder-<br>coated<br>steel | Powder-<br>coated<br>steel | Powder-coated<br>steel | Powder-coated<br>steel | Powder-<br>coated<br>steel | Powder-<br>coated<br>steel | | Height Range | 56-78" | None | 56-78" | None | 78" | None | | Weight Limit | 300 lb. | 250 lb. | 300 lb. | None | 300 lb. | None | ## VII. SAFETY AND EFFECTIVNESS The manual traction Teeter Decompression Devices have treatment position and generating the decompression forces in the same method. The difference in treatment position and the method of generating the decompression forces in the inversion type Teeter Decompression Devices does not affect the effectiveness and safety as it relates to the predicate device. Inversion decompression devices have been in use since the 1960's and are a commonly accepted form of traction. However, it is important for the users to read the "Instructions of Use" document to ensure that specified requirements (e.g., weight, height) are met. The amount of decompression force that is applied to the user is controlled by the user. ## VII. PERFORMANCE DATA The following evaluations were conducted on the Teeter Decompression Devices: - Safety evaluations (Inversion table and gravity boots only) ● - . Risk analysis ## VIX. CONCLUSIONS Based on the information submitted in the 510(k) application, Teeter Decompression Devices are as safe and effective as the legally marketed device (i.e., Lo-Bak TRAX) device.