Cleared Traditional

K162702 - Teeter Manual Inversion Table (FDA 510(k) Clearance)

Also includes:
Teeter Gravity Boots Teeter Forward Rotation Decompression Device Teeter Portable Decompression Device Teeter Horizontal Decompression Table

Class I Neurology device.

K162702 · Stl International, Inc. · Neurology device
Download Printable Device Report (PDF)
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Dec 2016
Decision
93d
Days
Class 1
Risk

K162702 is an FDA 510(k) clearance for the Teeter Manual Inversion Table. Classified as Apparatus, Traction, Non-powered (product code HST), Class I - General Controls.

Submitted by Stl International, Inc. (Puyallup, US). The FDA issued a Cleared decision on December 30, 2016 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 888.5850 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Stl International, Inc. devices

Submission Details

510(k) Number K162702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 148d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HST Apparatus, Traction, Non-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.5850
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.