Cleared Traditional

BTE CPM-10

K955105 · Baltimore Therapeutic Equipment Co. · Physical Medicine
Dec 1995
Decision
51d
Days
Class 1
Risk

About This 510(k) Submission

K955105 is an FDA 510(k) clearance for the BTE CPM-10, a Exerciser, Powered (Class I — General Controls, product code BXB), submitted by Baltimore Therapeutic Equipment Co. (Hanover, US). The FDA issued a Cleared decision on December 29, 1995, 51 days after receiving the submission on November 8, 1995. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5380.

Submission Details

510(k) Number K955105 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 1995
Decision Date December 29, 1995
Days to Decision 51 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

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