510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K971592Substantially Equivalent

Xtank2 Mobile Extremity Whirlpool System

The Silcraft Corp., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971592 is the FDA 510(k) clearance record for XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM, a class II device, cleared for The Silcraft Corp. on under FDA product code ILJ (Bath, Hydro-Massage). FDA records list 2 510(k) clearances for The Silcraft Corp. As of , FDA records show no recalls naming K971592.

Clearance record

Decision date
Received
(301 days to decision)
Product code
ILJ Bath, Hydro-Massage
Regulation
21 CFR 890.5100
Device class
Class II
Review panel
Physical Medicine
Applicant
The Silcraft Corp. 555 Thirteenth St. NW, Washington DC
510(k) summary
Summary
Third party review
No

Clearances, product code ILJ

Trailing 12 months

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

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