How does decompression compare to traction?
In 510k correspondence documents, the FDA required a competitor to clarify that decompression is, “unweighting due to distraction and positioning.” This was to decrease the potential confusion of the term with surgical decompression, and to clarify that decompression had not been proven to be different than traction. Several competitors go to great pains to try to distinguish themselves from “traction”. The fact is: All devices marketed as “decompression devices”, including the 3D ActiveTrac, are TRACTION DEVICES. If in doubt, ask the manufacturer for a copy of the FDA 510k submittal or find it here. In their 510k submittal documents, the manufacturers told the FDA that their devices were traction devices, and claimed substantial equivalence to other traction devices already on the market! All traction/decompression device manufacturers hope to convince you that only their devices have the essential features for the most effective decompression therapy. Fair enough. Just don’t let them
