Cleared Traditional

HAMEX TWO

K951028 · Northern Orthopaedic Products, Inc. · Physical Medicine
Dec 1995
Decision
279d
Days
Class 1
Risk

About This 510(k) Submission

K951028 is an FDA 510(k) clearance for the HAMEX TWO, a Exerciser, Powered (Class I — General Controls, product code BXB), submitted by Northern Orthopaedic Products, Inc. (Hamden, US). The FDA issued a Cleared decision on December 11, 1995, 279 days after receiving the submission on March 7, 1995. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5380.

Submission Details

510(k) Number K951028 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 1995
Decision Date December 11, 1995
Days to Decision 279 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