Cleared Traditional

HLE-1000 HIGH/LOW TREATMENT TABLE

K883659 · Rich-Mar Corp. · Physical Medicine
Oct 1988
Decision
48d
Days
Class 1
Risk

About This 510(k) Submission

K883659 is an FDA 510(k) clearance for the HLE-1000 HIGH/LOW TREATMENT TABLE, a Table, Powered (Class I — General Controls, product code INQ), submitted by Rich-Mar Corp. (Inola, US). The FDA issued a Cleared decision on October 13, 1988, 48 days after receiving the submission on August 26, 1988. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3760.

Submission Details

510(k) Number K883659 FDA.gov
FDA Decision Cleared SESE
Date Received August 26, 1988
Decision Date October 13, 1988
Days to Decision 48 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code INQ — Table, Powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.3760

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