Cleared Traditional

MBATH 1000 (60)

K052479 · Enneking Medical, Inc. · Physical Medicine
Jan 2006
Decision
139d
Days
Class 2
Risk

About This 510(k) Submission

K052479 is an FDA 510(k) clearance for the MBATH 1000 (60), a Bath, Hydro-massage (Class II — Special Controls, product code ILJ), submitted by Enneking Medical, Inc. (Kansas City, US). The FDA issued a Cleared decision on January 26, 2006, 139 days after receiving the submission on September 9, 2005. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5100.

Submission Details

510(k) Number K052479 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 2005
Decision Date January 26, 2006
Days to Decision 139 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code ILJ — Bath, Hydro-massage
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5100

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