510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K880486Substantially Equivalent

Dermgard System 800 and 900

Dermgard, Inc., New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880486 is the FDA 510(k) clearance record for DERMGARD SYSTEM 800 AND 900, a class II device, cleared for Dermgard, Inc. on under FDA product code IOQ (Bed, Flotation Therapy, Powered). FDA records list one 510(k) clearance for Dermgard, Inc. As of , FDA records show no recalls naming K880486.

Clearance record

Decision date
Received
(18 days to decision)
Product code
IOQ Bed, Flotation Therapy, Powered
Regulation
21 CFR 890.5170
Device class
Class II
Review panel
Physical Medicine
Applicant
Dermgard, Inc. 14 Wall St., New York NY
Third party review
No

Clearances, product code IOQ

Trailing 12 months

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

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