Cleared Traditional

DELUXE ADJUST-ANGLE BOARD-BK4066

K831538 · Fred Sammons, Inc. · Physical Medicine
Jun 1983
Decision
27d
Days
Class 1
Risk

About This 510(k) Submission

K831538 is an FDA 510(k) clearance for the DELUXE ADJUST-ANGLE BOARD-BK4066, a Exerciser, Non-measuring (Class I — General Controls, product code ION), submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 8, 1983, 27 days after receiving the submission on May 12, 1983. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5370.

Submission Details

510(k) Number K831538 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 1983
Decision Date June 08, 1983
Days to Decision 27 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code ION — Exerciser, Non-measuring
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5370