Cleared Traditional

ABLE GENERATION THERAPY TILT BENCH

K923753 · The Able Generation, Inc. · Physical Medicine
Jan 1993
Decision
185d
Days
Class 1
Risk

About This 510(k) Submission

K923753 is an FDA 510(k) clearance for the ABLE GENERATION THERAPY TILT BENCH, a Chair, Adjustable, Mechanical (Class I — General Controls, product code INN), submitted by The Able Generation, Inc. (Portsmouth, US). The FDA issued a Cleared decision on January 29, 1993, 185 days after receiving the submission on July 28, 1992. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3100.

Submission Details

510(k) Number K923753 FDA.gov
FDA Decision Cleared SESE
Date Received July 28, 1992
Decision Date January 29, 1993
Days to Decision 185 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code INN — Chair, Adjustable, Mechanical
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.3100

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