510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K922965Substantially Equivalent

Tumble Forms Tristander

Tumble Forms, Inc., Great Neck NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922965 is the FDA 510(k) clearance record for TUMBLE FORMS TRISTANDER, a class I device, cleared for Tumble Forms on under FDA product code INW (Table, Mechanical). FDA records list one 510(k) clearance for Tumble Forms. As of , FDA records show no recalls naming K922965.

Clearance record

Decision date
Received
(24 days to decision)
Product code
INW Table, Mechanical
Regulation
21 CFR 890.3750
Device class
Class I
Review panel
Physical Medicine
Applicant
Tumble Forms 55 Northern Blvd., Suite 301, Great Neck NY
510(k) summary
Statement
Third party review
No

Clearances, product code INW

Trailing 12 months

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

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