510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K933964Substantially Equivalent

The Cradle

The Primal Energy Research Foundation, Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K933964 is the FDA 510(k) clearance record for THE CRADLE, a class II device, cleared for The Primal Energy Research Foundation on under FDA product code IKZ (Bed, Patient Rotation, Powered). FDA records list one 510(k) clearance for The Primal Energy Research Foundation. As of , FDA records show no recalls naming K933964.

Clearance record

Decision date
Received
(413 days to decision)
Product code
IKZ Bed, Patient Rotation, Powered
Regulation
21 CFR 890.5225
Device class
Class II
Review panel
Physical Medicine
Applicant
The Primal Energy Research Foundation 2222 Westerland, Houston TX
510(k) summary
Statement
Third party review
No

Clearances, product code IKZ

Trailing 12 months

FDA records hold no clearances under product code IKZ in the trailing twelve months.

FDA records show no clearances under product code IKZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IKZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260