Cleared Traditional

PROM NAID

K843581 · Lossing Orthopedic, Inc. · Physical Medicine
Dec 1984
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K843581 is an FDA 510(k) clearance for the PROM NAID, a Equipment, Traction, Powered (Class II — Special Controls, product code ITH), submitted by Lossing Orthopedic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on December 11, 1984, 91 days after receiving the submission on September 11, 1984. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5900.

Submission Details

510(k) Number K843581 FDA.gov
FDA Decision Cleared SESE
Date Received September 11, 1984
Decision Date December 11, 1984
Days to Decision 91 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code ITH — Equipment, Traction, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5900

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