Cleared Traditional

PROSANA BELT

K812719 · Bandwagon, Inc. · Physical Medicine
Oct 1981
Decision
11d
Days
Class 1
Risk

About This 510(k) Submission

K812719 is an FDA 510(k) clearance for the PROSANA BELT, a Orthosis, Lumbar (Class I — General Controls, product code IQE), submitted by Bandwagon, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 6, 1981, 11 days after receiving the submission on September 25, 1981. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3490.

Submission Details

510(k) Number K812719 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 1981
Decision Date October 06, 1981
Days to Decision 11 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code IQE — Orthosis, Lumbar
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.3490