Cleared Traditional

Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table

K162702 · Stl International, Inc. · Neurology
Dec 2016
Decision
93d
Days
Class 1
Risk

About This 510(k) Submission

K162702 is an FDA 510(k) clearance for the Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table, a Apparatus, Traction, Non-powered (Class I — General Controls, product code HST), submitted by Stl International, Inc. (Puyallup, US). The FDA issued a Cleared decision on December 30, 2016, 93 days after receiving the submission on September 28, 2016. This device falls under the Neurology review panel. Regulated under 21 CFR 888.5850.

Submission Details

510(k) Number K162702 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2016
Decision Date December 30, 2016
Days to Decision 93 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HST — Apparatus, Traction, Non-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 888.5850