510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K965207Substantially Equivalent

Rid-Decube II

Skin Care Management, Inc., East Burnswick NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K965207 is the FDA 510(k) clearance record for RID-DECUBE II, a class II device, cleared for Skin Care Management, Inc. on under FDA product code FNM (Mattress, Air Flotation, Alternating Pressure). FDA records list one 510(k) clearance for Skin Care Management, Inc. As of , FDA records show no recalls naming K965207.

Clearance record

Decision date
Received
(237 days to decision)
Product code
FNM Mattress, Air Flotation, Alternating Pressure
Regulation
21 CFR 880.5550
Device class
Class II
Review panel
General Hospital
Applicant
Skin Care Management, Inc. 29 Ainsworth Ave., East Burnswick NJ
510(k) summary
Summary
Third party review
No

Clearances, product code FNM

Trailing 12 months

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

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