Cleared Traditional

K925195 - MALIBU BATHING SYSTEM (FDA 510(k) Clearance)

K925195 · Medi-Man Rehabilitation Products, Inc. · Physical Medicine device

Oct 1994

Decision

732d

Days

Class 2

Risk

K925195 is an FDA 510(k) clearance for the MALIBU BATHING SYSTEM. This device is classified as a Bath, Hydro-massage (Class II - Special Controls, product code ILJ).

Submitted by Medi-Man Rehabilitation Products, Inc. (Canada, L4w 1p4, CA). The FDA issued a Cleared decision on October 17, 1994, 732 days after receiving the submission on October 15, 1992.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5100.

Submission Details

510(k) Number	K925195 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 15, 1992
Decision Date	October 17, 1994
Days to Decision	732 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement