Cleared Traditional

K770611 - PARALLEL BARS
(FDA 510(k) Clearance)

Apr 1977
Decision
8d
Days
Class 1
Risk

K770611 is an FDA 510(k) clearance for the PARALLEL BARS. This device is classified as a Bars, Parallel, Exercise (Class I - General Controls, product code IOE).

Submitted by Will Ross Co. (Mchenry, US). The FDA issued a Cleared decision on April 8, 1977, 8 days after receiving the submission on March 31, 1977.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5370.

Submission Details

510(k) Number K770611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1977
Decision Date April 08, 1977
Days to Decision 8 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary

Device Classification

Product Code IOE — Bars, Parallel, Exercise
Device Class Class I - General Controls
CFR Regulation 21 CFR 890.5370