Cleared Traditional

K844976 - MEDI-MAN WATER POWERED BATH LIFT & HYDRAULIC LIFT
(FDA 510(k) Clearance)

Apr 1985
Decision
96d
Days
Class 1
Risk

K844976 is an FDA 510(k) clearance for the MEDI-MAN WATER POWERED BATH LIFT & HYDRAULIC LIFT. This device is classified as a Lift, Patient, Non-ac-powered (Class I - General Controls, product code FSA).

Submitted by Medi-Man Rehabilitation Products, Inc. (Mississauga, CA). The FDA issued a Cleared decision on April 1, 1985, 96 days after receiving the submission on December 26, 1984.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5510.

Submission Details

510(k) Number K844976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1984
Decision Date April 01, 1985
Days to Decision 96 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary

Device Classification

Product Code FSA — Lift, Patient, Non-ac-powered
Device Class Class I - General Controls
CFR Regulation 21 CFR 880.5510