Cleared Traditional

K933964 - THE CRADLE
(FDA 510(k) Clearance)

K933964 · The Primal Energy Research Foundation · Physical Medicine

Oct 1994

Decision

413d

Days

Class 2

Risk

K933964 is an FDA 510(k) clearance for the THE CRADLE. This device is classified as a Bed, Patient Rotation, Powered (Class II — Special Controls, product code IKZ).

Submitted by The Primal Energy Research Foundation (Houston, US). The FDA issued a Cleared decision on October 3, 1994, 413 days after receiving the submission on August 16, 1993.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5225.

Submission Details

510(k) Number	K933964 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 16, 1993
Decision Date	October 03, 1994
Days to Decision	413 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement