BASS ANTALGIC-TRAK

K042482 · Traction Masters, LLC · ITH · Mar 21, 2005 · Physical Medicine

Device Facts

• Record ID: K042482
• Device Name: BASS ANTALGIC-TRAK
• Applicant: Traction Masters, LLC
• Product Code: ITH · Physical Medicine
• Decision Date: Mar 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Patients with disc protrusions. Patients with mild disc herniations. Patients with pinched nerves. Patients with limited spinal flexibility. Patients with muscle spasms. Patients with spinal vertebral fixations. Patients with spinal facet imbrication and fixation. Patients with spinal nerve root radiculitis. Patients with foraminal encroachment.

Device Story

Bass Antalgic-Trak is a multi-functional, chair-like powered traction table. Device accommodates patients in sitting or reclined positions (up to 90 degrees). Input: clinician-set parameters via control panel. Operation: electric single-columned actuator motors power seat-bottom, cervical traction, thigh extension, and table recline; manual foot pedal option for traction. Patient secured via leather/vinyl straps at iliac crest, shins, and forehead. Seat-bottom manually rotates 80 degrees left/right and flexes 45 degrees forward/backward; thigh length adjustable by 6 inches. Used in clinical settings by clinicians to provide spinal traction. Output: mechanical force applied to patient spine/musculature. Benefit: relief of symptoms associated with spinal conditions through controlled traction.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and intended use compared to legally marketed predicate devices.

Technological Characteristics

Powered traction table; chair-like form factor; vinyl-covered dense foam cushions on plywood backing. Actuation: electric single-columned actuator motors for recline, cervical traction, thigh extension, and seat-bottom positioning. Manual adjustment for rotation and flexion. Connectivity: none (standalone). Power source: electric. Sterilization: not applicable (surface cleaning).

Indications for Use

Indicated for patients with disc protrusions, mild disc herniations, pinched nerves, limited spinal flexibility, muscle spasms, spinal vertebral fixations, spinal facet imbrication/fixation, spinal nerve root radiculitis, and foraminal encroachment.

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

• DRS System (K981822)
• Tru-Trak Traction Table (K8893448)
• Vax-D Therapeutic Table (K951622)
• Saunders 3-D activetrac (K001712)
• Jilco Traction Flexion Chair (K001361)

Submission Summary (Full Text)

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Koy2482

MAR 2 1 2005

Image /page/0/Picture/2 description: The image shows a cartoon drawing of an atom with legs and a large eye. The atom is depicted with a central nucleus and orbiting electrons. The atom has two legs, giving it the appearance of walking. A large eye is positioned above the atom's structure, adding a whimsical touch to the image.

TRACTION MASTERS, INC. AKA SPINETRONICS, LLC 737 NW 6514 Place PARKLAND, FLORIDA 33076

Dr. David B Bass, Pres. Cell. 516 4.26-95 IR. David D Denny, V.P. Cell: 954 5:99-9766

### 510(k) summary

| Company Name: | Traction Masters, Inc. AKA: Spinetronics, LLC<br>9737 NW 65 PL |
|-----------------|----------------------------------------------------------------|
| | Parkland, Florida 33076 |
| Telephone: | 954-752-1994 |
| Fax: | 954-693-8834 |
| Contact Person: | David B Bass<br>Scott Denny |
| Date Prepared: | September 8th, 2004 |

| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Trade Name: | Bass Antalgic-Trak |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Common Name: | Powered Traction Table |
| Classification Name: | Powered Traction Table (per CFR 890.5900) |

#### Indications for Use

- 1) Patients with disc protrusions.
- 2) Patients with mild disc herniations.
- 3) Patients with pinched nerves.
- 4) Patients with limited spinal flexibility.
- 5) Patients with muscle spasms.
- 6) Patients with spinal vertebral fixations.
- 7) Patients with spinal facet imbrication and fixation.
- 8) Patients with spinal nerve root radiculitis.
- 9) Patients with foraminal encroachment.

#### Substantially Equivalent To:

The Bass Antalgic-Trak is substantially equivalent to products currently in commercial distribution. These include the:

- 1) The DRS System (K981822)
- 2) The Tru-Trak Traction Table (K8893448)
- 3) The Vax-D Therapeutic Table (K951622)
- 4) The Saunders 3-D activetrac (K001712)
- 5) The Jilco Traction Flexion Chair (K001361)

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ત્ત્વન્યું તે કરી

TRACTION MASTERS, INC. AKA SPINETRONICS, LLC Parkland, Florida 33076

Image /page/1/Picture/2 description: The image shows a cartoon drawing of an atom with a face and legs. The atom has a six-pointed star in the center with a circle in the middle. There are two oval shapes orbiting the star. The atom has two legs and a face with one eye.

DR, DAVID B BASS, PRES. CELL: 516-42 DR. SCOTT DENNY, V.P. CELL: 954-59

## Device Description:

The Bass Antalgic-Trak is a multi-functional traction device. It is chair like in its appearance and The Dass Amargic Truk is a mark tull sit upon a chair or recliner. The chair/table can recline the patient 90 degrees. It maintains the patient's sitting posture during the recline. the patient 90 degrees: it maintains the parchies befores 24 inches wide by 20 inches tong by I it is seat bottom is a viry? covered assist as a seat bottom, at the knee joint, the 5 inches ticep backed by 74 men pry roomes as a calf support. The cushion continues 18 inches to support the calves. This seat-bottom section can manually rotate 80 degrees left or right, support the carves. This sout ootion socure, manually flex forward and backwards 45 degrees. manually facerary and 55 asglobal to backwards 6 inches by engaging an electric The chiller motor. This is to accommodate taller patients with longer thighs. There are 3 leather/vinyl straps that secure the patient to the seat bottom. Strap 1 securers over the iliac leather vinyl straps that secure the parent stup 3td secures over the shins. The seat back of the chair is viral 2 socures over the might is 20 inches tall and 18 inches wide and 3 inches deep Chan is villy covered done roam lead is vinyl covered dense foam. It is 12 inches tall by 8 backed with 74 men pry wood. It is mounted to the mounted to the upper portion of the chair's top frame. The headpiece has a vinyl strap to secure the forehead onto the headpiece. the chair o top the chair/table is 60 inches long. In the upright posture, the chair height is 60 which rechned, the seat-bottom is powered by an electric single-columned actuator motor. The headpiece cervical traction is powered by an electric single-columned actuator motor. The thigh extension of the seat bottom is powered by an electric single-columned actuator motor. The table/chair recline is powered by an electric single-columned actuator motor. The seat-I he table/enan footine is powered of as e cervical traction may be powered manually using foot pottom fulliour traction as foot pedal for each. The traction can be "auto" cycled using the control panel. The thigh adjustment length and table/chair recline must be engaged using the control panel. The clinician must set all functions.

David B Bass, Inventor of the Bass Antalgic-Trak Traction Masters, LLC., AKA Spinetronics, LLC. March 3, 2005

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three curved lines representing its body and wings. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.

MAR 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

Dr. David Bass President Traction Masters, Inc. 9737 NW 65th Way Parkland, Florida 33076

Re: K042482

Trade/Device Name: Bass Antalgic-Trak Regulation Number: 21 CFR 890.5900 Regulation Name: Power traction equipment Regulatory Class: II Product Code: ITH Dated: June 1, 2004 Received: September 13, 2004

Dear Dr. Bass:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications felerenced above and have acterings ally marketed predicate devices marketed in interstate for use stated in the encrosale) to regardy the Medical Device Amendments, or to commerce problem to May 20, 1978, the cannot with the provisions of the Federal Food, Drug, devices mat have been recuire approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require subject to the general controls provisions of the Act. The r ou may, merceboo, manel a e Act include requirements for annual registration, listing of general controls provisions of the simment of the prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (500 abor b) the existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of may be subject to such additional controllations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous neements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 Tcase be advised that I Drived... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . that I DA has made a determinations administered by other Federal agencies. You must of any it cach statutes and regulations and limited to: registration and listing (21 comply with an the Act 31equirements,01); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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# Page 2 -- Dr. David Bass

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin makemig your article quivalence of your device to a legally premarket notification. The PDA midning of substantal equive 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 If you desire specific advice for your de need on one note the regulation entitled, the regulation entitled, contact the Office of Compliance an [phone] (21CFR Patt 807.97). You may obtain " Misbranding by reference to premation on <= < < < 1 trom the Division of Small
other general information on your responsibilities under the Act from worker (800) 638, 200 other general information on your responsibilities and with the number [phone] or and Manufacturers, International and Consumer Fiberantos on one of thindustry/support/index.html.

Sincerely yours,

Sincerely yours,

Mark-Ol-Millenn

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

Device Name: Bass Antalgic-Trak

Indications for Use:

- leations with disc protrusions.
- 2) Patients with mild disc herniations.
- Patients with pinched nerves. 3)
- 4) Patients with limited spinal flexibility.
- 5) Patients with muscle spasms.
- 5) 1 utlents with spinal vertebral fixations.
- 6) Patients with spinal vortebrarion and fixation.
7) Patients with spinal facet imbrication and fixation.
- 8) Patients with spinal nerve root radiculitis.
- 9) Patients with foraminal encroachment.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Milherson

Division of General, Restorative, and Neurological Devices

210(K) Num

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