(189 days)
No
The device description details a mechanical traction device with manual and automated (cycled) functions controlled by a clinician. There is no mention of AI or ML in the description of its operation or capabilities.
Yes
The device is clearly indicated for the treatment of various medical conditions related to the spine, such as disc protrusions, herniations, pinched nerves, and muscle spasms, and its function involves applying traction to the spinal column. These are all therapeutic applications aimed at alleviating symptoms or treating ailments.
No
Explanation: The provided text describes a "multi-functional traction device" used for treating various spinal conditions. Its function is to apply traction, not to diagnose medical conditions or identify diseases. The "Intended Use / Indications for Use" section lists conditions that the device is used to treat, not to diagnose.
No
The device description clearly describes a physical, multi-functional traction device with mechanical and electrical components (motors, straps, chair structure). It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The description clearly outlines a physical traction device designed to apply mechanical forces to the spine. It involves a chair-like structure, motors for movement and traction, and straps to secure the patient.
- Intended Use/Indications for Use: The listed indications are all related to musculoskeletal conditions affecting the spine (disc protrusions, herniations, pinched nerves, etc.). These are treated through physical intervention, not by analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory tests.
The device is a therapeutic device used for physical treatment of spinal conditions.
N/A
Intended Use / Indications for 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.
Product codes
ITH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K981822, K8893448, K951622, K001712, K001361
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5900 Power traction equipment.
(a)
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.(b)
Classification. Class II (performance standards).
0
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
9737 NW 65 PL |
|-----------------|----------------------------------------------------------------|
| | Parkland, Florida 33076 |
| Telephone: | 954-752-1994 |
| Fax: | 954-693-8834 |
| Contact Person: | David B Bass
Scott Denny |
| Date Prepared: | September 8th, 2004 |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| Trade Name: | Bass Antalgic-Trak |
|---|---|
| Common Name: | Powered Traction Table |
| Classification Name: | Powered Traction Table (per CFR 890.5900) |
Indications for 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.
Substantially Equivalent To:
The Bass Antalgic-Trak is substantially equivalent to products currently in commercial distribution. These include the:
-
- The DRS System (K981822)
-
- The Tru-Trak Traction Table (K8893448)
-
- The Vax-D Therapeutic Table (K951622)
-
- The Saunders 3-D activetrac (K001712)
-
- The Jilco Traction Flexion Chair (K001361)
1
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
2
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.
3
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 (210) 210-01-11 (21CFR Patt 807.97). You may obtain " Misbranding by reference to premation on