AKRON ATP9 TRACTION MACHINE

K992733 · Huntleigh Technology, Inc. · ITH · Nov 10, 1999 · Physical Medicine

Device Facts

• Record ID: K992733
• Device Name: AKRON ATP9 TRACTION MACHINE
• Applicant: Huntleigh Technology, Inc.
• Product Code: ITH · Physical Medicine
• Decision Date: Nov 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ATP9 traction is intended to provide traction and mobilization of lumbar and cervical muscles and vertebrae when used in conjunction with fixed or variable height traction tables. It is indicated for use as a treatment for spinal root impingement, joint hypomobility, degenerative joint disease, discogenic pain and compression fractures.

Device Story

ATP9 Traction Machine provides mechanical traction/mobilization for lumbar and cervical regions; used with fixed or variable height traction tables. Device utilizes DC-powered motor gearbox connected to rope drum via clutch; rope attaches to patient via harness. Clinician selects therapy mode (static, intermittent, progressive, regressive, cyclic) and force parameters (2-200 lbs high force; 2-196 lbs low force; 1-99 second hold/rest times). System monitors tension via strain gauge; detects eleven fault conditions including motor malfunction, power failure, and excess tension. Used in clinical settings by healthcare professionals to treat spinal conditions; output provides controlled physical force to patient to alleviate pain and improve mobility.

Clinical Evidence

Bench testing only. Device safety verified through compliance with international standards including IEC601-1, EN60601-1-2, EN60601-1/A2, and EN60601-1-4. No clinical data provided.

Technological Characteristics

DC-powered motor gearbox with clutch-driven rope drum. Force range: 2-200 lbs (high), 2-196 lbs (low). Timing: 1-99 seconds. Integrated strain gauge for tension monitoring. Fault detection for 11 conditions (e.g., motor, power, strain gauge, tension). Standards: IEC601-1, EN60601-1-2, EN60601-1/A2, EN60601-1-4. Manufacturing: ISO9002, EN46002.

Indications for Use

Indicated for patients requiring traction and mobilization of lumbar and cervical muscles and vertebrae for treatment of spinal root impingement, joint hypomobility, degenerative joint disease, discogenic pain, joint pain, and compression fractures.

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

• TEC Traction Machine (K834405)
• ESCOTEK EST TRAC 401 (K844385)

Submission Summary (Full Text)

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HUNTLEIGH HEALTHCARE7324461938 NOV. 9. 1999 11:42AM

| Nov 10 1999 | K 992733 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 510(k) Summary |
| | Akron ATP9 Traction Machine |
| Submitters Name: | Audrey Witko<br>V.P., Administration & Compliance<br>Huntleigh Healthcare Inc.<br>227 Route 33 East<br>Manalapan, NJ 07726<br>Telephone: [phone]<br>Fax: [phone] |
| Name of Device: | Akron ATP9 Traction Machine |
| Manufactured By: | Huntleigh Akron<br>1 Farthing Road<br>Ipswich, Suffolk IP1 5AP<br>United Kingdom |
| Classification Name: | Power traction equipment (21 CFR §890.5900) ITH |
| Predicate Devices: | TEC Traction Machine (K834405)<br>ESCOTEK EST TRAC 401 (K844385) |

#### Device Description:

The ATP9 traction is intended to provide traction and mobilization of lumbar and cervical muscles and vertebrae when used in conjunction with fixed or variable height traction tables. It is indicated for use as a treatment for spinal root impingement, joint hypomobility, degenerative joint disease, discogenic pain and compression fractures.

The ATP9 machine mounts on available Akron traction tables and mobile traction stand. Traction force is applied to the patient using Akron traction harnesses. The ATP9 utilizes a DC-powered motor gearbox connected to a rope drum via a clutch. The rope is connected to a harness attached to the patient. The high force hold time and low force rest time programs are selectable from 1 second minimum to 99 seconds maximum, with a high traction force range of 2-200 lbs. and low traction force range of 2-196 lbs. There are seven combinations of therapy including static, intermittent, progressive, regressive and cyclic.

### Safety Considerations:

There are eleven fault conditions detected by the ATP9 including, control system Failure, low supply voltage, AC power failure, motor power supply failure, battery failure, excess tension detected, high force control setting failure, strain gauge failure, strain gauge mismatch, motor malfunction, unexpected increase in tension, and cord drive fault. The ATP9 conforms to the following international standards: IEC601-1, EN60601-1-2: 1993, EN60601-1/A2: 1995, EN60601-1-4: 1997. Manufactured to ISO9002 and EN46002.

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Image /page/1/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an abstract symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to create a sense of depth and connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nov 1 0 1999

Ms. Audrey Witco Vice President Administration, Compliance and Clinical Affairs Huntleigh Healthcare Incorporated 227 Route 33 East Manalapan, New Jersey 07726

K992733 Re: Akron ATP9 Traction Machine Product Code: ITH Regulatory Class: II Dated: August 9, 1999 Received: August 13, 1999

Dear Ms. Witco:

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 The general controls provisions of the Act 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. ਕੇ 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 requlation (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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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

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#### Page 2 - Ms. Audrey Witco

requlations. 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.

If you desire specific advice for your device on our labeling requlation (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, "Misbranding 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 at [phone], or at its Internet address

"http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Enclosure

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# Eriller los Mesen essame Chuliatorgiene Henline & .. P

| 510(k) Number (if known): | K992733 |
|---------------------------|-----------------------------|
| Device Name: | AKRON ATP9 TRACTION MACHINE |
| Indications for Use: | |

The ATP9 traction is intended to provide traction and mobilization of lumbar and cervical
ist the and vertebrae when used in conjunction with fixed are in the below to the muscles and verte interned to provide mobilization of lumbar and cervices
tables. It is indicated to provide with fixed of variable height traction tables . It is indicated for use as a treatment with fixed or variable height he work in the mated for use as a treatment for spinal root impingement, joint
hypomobility, degenerative joint disease, discogenic pain, joint pain and compression
fracture

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| Prescription Use<br>(Per 21 CFR 801.109) | X |
|------------------------------------------|---|
|------------------------------------------|---|

Concurence of CDRH, Office of Device Evaulation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | K992733 |
| 510(k) Number | |

(Optional Format 3-10-98)

(Posted July 1, 1998)

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Rev. B- 1/99