# K981822: DRS System

- Pathway: 510(k) (Traditional)
- Applicant: Professional Distribution Systems, Inc.
- Decided: Jun 24, 1998 after 33 days
- Product code: ITH (Equipment, Traction, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K894435 (1989). 3 ancestors in all.
16 later devices descend from it; 8 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K844385: Escotek Est Trac 401, Nor-Am Patient Care Products, Inc. (1985) Summary page 1.
- K951622: Vax-D Therapeutic Table, Vat-Tech, Inc. (1996) Summary page 1.

## Most influential descendants
- K030060: Spinemed (2003), 10 descendants of its own
- K031862: Spinerx-LDM (2003), 9 descendants of its own
- K053223: Triton/Tru-Trac/TX/Triton DTS Traction (2006), 8 descendants of its own
- K992545: TM-300 Traction System (1999), 2 descendants of its own
- K151640: Eltrac 471 (2015), 1 descendant of its own

## Indications for use
The DRS System provides a program of treatments for relief from pain for those patients suffering with low back pain. Each treatment consists of a physician prescribed treatment period on the DRS System and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain. It relieves pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.

Source page: https://510kreport.com/device/K981822
Methodology: https://510kreport.com/methodology