THE CRADLE— 510(k) K933964

Name: FDA 510(k) clearance K933964
Creator: U.S. Food and Drug Administration
Published: 1994-10-03

Substantially Equivalent

The Primal Energy Research Foundation

FDA 510(k) clearance K933964 for THE CRADLE, Substantially Equivalent on 1994-10-03. Applicant: The Primal Energy Research Foundation. Device class: 2.

Clearance details

Applicant: The Primal Energy Research Foundation
Product code: Code IKZ
Device class: Class 2
Regulation: 21 CFR 890.5225
Advisory panel: Physical Medicine
Date received: 1993-08-16
Decision date: 1994-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IKZ

view all

K972486 — PRESSUREGUARD IV1998-02-20
K972111 — RUMORS DYNAMIC AIR THERAPY UNIT1998-02-02
K962788 — CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM1997-04-30
K954671 — THE FREEDOM BED1996-04-01
K950756 — PULMONEX DYNAMIC AIR THERAPY UNIT1995-05-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.