EXTENTRAC ELITE— 510(k) K031996

Substantially Equivalent

Advanced Back Technologies

FDA 510(k) clearance K031996 for EXTENTRAC ELITE, Substantially Equivalent on 2004-07-23. Applicant: Advanced Back Technologies. Device class: 2.

Clearance details

Applicant: Advanced Back Technologies
Product code: Code ITH
Device class: Class 2
Regulation: 21 CFR 890.5900
Advisory panel: Physical Medicine
Date received: 2003-06-27
Decision date: 2004-07-23
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Syosset, NY, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K031996

K-number listed on FDA's recall record

Z-1717-2015 — Extentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression table, for traction)Class II·Terminated·Advanced Back Technologies, Inc.·20150513
Z-1718-2015 — Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for traction)Class II·Terminated·Advanced Back Technologies, Inc.·20150513

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K031996.

Data sourced from openFDA. This site is unofficial and independent of the FDA.