510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K903321Substantially Equivalent

Sandbox I, Sandbox II, Sandbox Jr.

Sandbox Ent., Mt. Gilead OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903321 is the FDA 510(k) clearance record for SANDBOX I, SANDBOX II, SANDBOX JR., a class II device, cleared for Sandbox Ent. on under FDA product code IRT (Pad, Heating, Powered). FDA records list one 510(k) clearance for Sandbox Ent. As of , FDA records show no recalls naming K903321.

Clearance record

Decision date
Received
(209 days to decision)
Product code
IRT Pad, Heating, Powered
Regulation
21 CFR 890.5740
Device class
Class II
Review panel
Physical Medicine
Applicant
Sandbox Ent. P.O. Box 395, Mt. Gilead OH
Third party review
No

Clearances, product code IRT

Trailing 12 months

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

FDA records show no clearances under product code IRT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IRT, 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