HANG UPS POWER II

K991835 · Stl Intl., Inc. · ITH · Dec 20, 1999 · Physical Medicine

Device Facts

• Record ID: K991835
• Device Name: HANG UPS POWER II
• Applicant: Stl Intl., Inc.
• Product Code: ITH · Physical Medicine
• Decision Date: Dec 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The InvertAlign is a non-invasive traction device that utilizes gravity to apply traction. The traction force is a result of the natural force of gravity, and is affected only by the user's body weight and angle of invertAlign is indicated to increase intervertebral dimensions, to decrease pressure on the intervertebral discs, to stretch and relax muscles, and to temporarily relieve back pain associated with the listed conditions.

Device Story

InvertAlign is a motorized, gravity-assisted traction table. User stands on platform, secures ankles in foam-padded clamps, and reclines. Motorized controls allow user or supervisor to adjust inversion angle; device can stop at any angle or exceed 90 degrees for full inversion. Emergency crank provided for manual return during power loss. Device uses gravity and user body weight for traction; no mechanical force applied to body. Intended for use in clinic or home settings to stretch weight-bearing joints (ankles, knees, hips, spine) and relieve back pain. Benefits include non-invasive, natural traction and reduced user error compared to manual inversion tables.

Clinical Evidence

No clinical data provided. Bench testing only. Safety and effectiveness supported by historical use of inversion therapy since the 1960s and comparison to legally marketed predicate devices.

Technological Characteristics

Gravity-assisted traction table. Motorized tilt mechanism with emergency manual ascension crank. Foam-padded ankle clamps for user securement. Operates via user body weight and inversion angle. No mechanical force applied to body. Standalone device.

Indications for Use

Indicated for individuals seeking gravity-assisted traction to increase intervertebral dimensions, decrease intervertebral disc pressure, stretch/relax muscles, and temporarily relieve back pain.

Regulatory Classification

Identification

Powered traction equipment consists of powered devices intended for medical purposes for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body.

Predicate Devices

• F5000-Series (510(k) Exempt)
• InverChair (K821002)
• Vax-D (K951622)
• ATT-300 (K944699)
• Midland Vari-trac II (K862746)

Submission Summary (Full Text)

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DEC 2 0 1999

# 510(k) Summary for Hang Ups InvertAlign

K991835

| Submitter: | Roger C. Teeter<br>Hang Ups Div. of STL International, Inc.<br>10004 - 162nd St. Ct. E<br>Puyallup, WA 98375<br>Phone: [phone]<br>Fax: [phone] | | |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|---------------------------------|
| Contact: | Same as above. | | |
| Date prepared: | December 17, 1999 | | |
| Name of device: | Hang Ups InvertAlign | | |
| Common or Usual Name: | Rotation-Powered Gravity-Assisted Traction Table<br>Inversion Table | | |
| Classification Name: | Equipment, Traction, Powered | | |
| Predicate Devices: | F5000-Series<br>InverChair<br>Vax-D<br>ATT-300<br>Midland Vari-trac II | 510(k) Exempt<br>K821002<br>K951622<br>K944699<br>K862746 | HST<br>ITH<br>ITH<br>ITH<br>ITH |

#### Device Description:

The InvertAlign is a non-invasive traction device that utilizes gravity to apply traction. The user straddles the main shaft of the InvertAlign and while resting his seat on the base of the table frame, the user places each foot on the foot platform. The user's ankles slide between the foam padded ankle clamps. In the InvertAlign's full upright position, the user will be reclined in the supine position at approximately 10 degrees off vertical. By pulling the locking pin and locking the clamps securely to the ankles, the user or supervisor is able to manually adjust the foam clamps to form a secure but comfortable fit. The user or supervisor may then use the tilt control button to increase / decrease the angle of inversion. The InvertAlign can be stopped at any angle and is able to tilt beyond ninety degrees from horizontal to allow the user to hang and move freely at full inversion.

#### Intended Use:

The InvertAlign is a non-invasive traction device that utilizes gravity to apply traction. The traction force is a result of the natural force of gravity, and is affected only by the user's (510(k) Summary, cont.)

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pg 4 96

body weight and angle of invertAlign is indicated to increase intervertebral dimensions, to decrease pressure on the intervertebral discs, to stretch and relax muscles, and to temporarily relieve back pain associated with the listed conditions. Explanations for these claims are found in Appendix C.

### Technological Characteristics:

The InvertAlign is a gravity-assisted traction device. The traction force applied to the body is a measure of the user's weight and angle of inversion. The InvertAlign itself does not apply a mechanical force to the body. The device to which the InvertAlign is most similar is the F5000III Inversion Table. Essentially, the only difference between these two devices is that the InvertAlign is operated by a motor. The InvertAlign tilts with the help of motorized controls, whereas the F5000II uses the body's arm movements to control the angle of inversion. With the motor, this upgraded inversion table no longer requires the users to adjust the table to individual height settings, reducing the possibility of user error.

Another device to which the InvertAlign is very similar is the InverChair. The main difference between these two devices is the body position in which the device places the user. The InverChair is a motorized device which inverts the patient in a 90/90 position (seated). The InvertAlign inverts the user in a standing, supine position. By allowing for a full-body inversion experience, the InvertAlign gives the body a chance to stretch and perform body-enhancing exercises.

The other three devices to which the InvertAlign is compared, the Vax-D, ATT-300, and Midland Vari-trac II, physically apply a traction force to the body. This is the vital difference between these devices and the InvertAlign the InvertAlign allows for a natural form of traction, whereas the Vax-D, ATT-300, and Midland Vari-trac II make use of a mechanically applied form of traction. The InvertAlign is a safer alternative form of traction because it relies on gravity and the user's body weight to apply the traction force. The InvertAlign is easy to use and does not require the help of a medical supervisor to operate. The InvertAlign may be returned upright at any time and requires only one user-sensitive adjustment-the foot clamps must be fitted to the users' ankles.

#### Summary of Safety and Effectiveness:

Inversion has been used since the age of Hypocrites and has been widely accepted as a natural form of traction in the United States since the 1960's. The fundamental purpose of the Hang Ups InvertAlign is to permit the application of inversion to the ankles, knees, hips and spine (all weight-bearing joints). The important attributing to the safety and effectiveness of the device include the easy-to-use controls which require only one user-specific adjustment (i.e.: adjustable ankle clamps), the moderate, controlled rate of inversion and ascension, and the use of gravity to apply a natural and non-invasive traction force to weightbearing joints. The emergency ascension crank may be used in the event of a power outage to return the user to an upright position.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three wing-like shapes.

AUG 2 5 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Roger C. Teeter STL International, Inc. 10004 - 162nd Street, Ct. E. Puyallup, Washington 98375

Re: K991835 Trade Name: Hang Ups InvertAlign Regulatory Class: II Product Code: ITH Dated: December 17, 2000 Received: December 17, 2000

Dear Mr. Teeeter:

This letter corrects our substantially equivalent letter of December 20, 1999, which incorrectly identified your device as a prescription use device on the indications for use enclosure.

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

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Page 2 - Mr. Roger C. Teeter

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 CFF) Part 801 and If you desire specific advice for your devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, [phone]. Additionally, for quee at [phone]. Also, please note the regulation prease contact the Office or Comphanes as (as a ) Dotification" (21 CFR 807.97). Other general entitled, "Misoraliding by releveles to promation hours be obtained from the Division of Small information on your responsionnes ander the new now [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Neville Jackson

4- 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

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## Statement of Indications for Use

510(k) Number (if known): K991835

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indication for Use:

Hang Ups InvertAlign is intended to be used for inversion, a method of gravity-assisted traction that utilizes the user's own body weight. Inversion is indicated of gray intervertebral dimentions, decrease pressure on the intervetebral discs, stretch and relax muscles, and temporarily relieve back pain associated with the listed contitions.

(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Pcr 21 CFR 801.109)

OR

Over-the-Counter Use

Arnold Sager

(Division Sign-Off) Division of Cieneral Restorative Devices 510(k) Number _

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Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized depiction of an eagle with three wings, symbolizing health, services, and human concerns. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

DEC 2 0 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Roger C. Teeter STL International, Inc. 10004 - 162nd Street, Ct. E. Puyallup, Washington 98375

Re: K991835 Trade Name: Hang Ups InvertAlign Regulatory Class: II Product Code: ITH Dated: December 17, 1999 Received: December 17, 1999

Dear Mr. Teeter:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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Page 2 - Mr. Roger C. Teeter

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Mishranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

tocoe

Jim È. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure