Cleared Traditional

THERAPACER 3000

K925666 · Kvm Technologies, Inc. · Physical Medicine
Mar 1993
Decision
119d
Days
Class 1
Risk

About This 510(k) Submission

K925666 is an FDA 510(k) clearance for the THERAPACER 3000, a Exerciser, Powered (Class I — General Controls, product code BXB), submitted by Kvm Technologies, Inc. (Houston, US). The FDA issued a Cleared decision on March 9, 1993, 119 days after receiving the submission on November 10, 1992. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5380.

Submission Details

510(k) Number K925666 FDA.gov
FDA Decision Cleared SESE
Date Received November 10, 1992
Decision Date March 09, 1993
Days to Decision 119 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code BXB — Exerciser, Powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5380