510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061242Substantially Equivalent

Dermatherapy, Model 22216

Precision Fabrics Group, Inc., Norfolk MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061242 is the FDA 510(k) clearance record for DERMATHERAPY, MODEL 22216, a class I device, cleared for Precision Fabrics Group, Inc. on under FDA product code FMW (Cover, Mattress (Medical Purposes)). FDA records list 2 510(k) clearances for Precision Fabrics Group, Inc., from to . As of , FDA records show no recalls naming K061242.

Clearance record

Decision date
Received
(267 days to decision)
Product code
FMW Cover, Mattress (Medical Purposes)
Regulation
21 CFR 880.6190
Device class
Class I
Review panel
General Hospital
Applicant
Precision Fabrics Group, Inc. 18 Bridie Ln., Norfolk MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FMW

Trailing 12 months

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

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