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510(k) K061242

DERMATHERAPY, MODEL 22216 by Precision Fabrics Group, Inc. — Product Code FMW

K061242 is an FDA 510(k) premarket notification submitted by Precision Fabrics Group, Inc. for the device "DERMATHERAPY, MODEL 22216". The FDA issued a decision of Substantially Equivalent on January 25, 2007. The device falls under product code FMW (Cover, Mattress (Medical Purposes)), a Class I device regulated under 21 CFR 880.6190. Precision Fabrics Group, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2007
Date Received
May 3, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cover, Mattress (Medical Purposes)
Device Class
Class I
Regulation Number
880.6190
Review Panel
HO
Submission Type

Other clearances by Precision Fabrics Group, Inc.

  • K152884 — DermaTherapy Bed Linens (June 20, 2016)

Other clearances for product code FMW

  • K152884 — DermaTherapy Bed Linens (June 20, 2016)
  • K001003 — Z-NET (December 10, 2001)
  • K992702 — EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PI (November 8, 1999)
  • K940327 — INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MAT (February 25, 1994)
  • K935220 — CORE PREVENT MATTRESS MODIFICATION (November 29, 1993)
  • K924807 — REUSABLE INCONTIENT UNDERPAD (February 10, 1993)
  • K924477 — WIPEABLE PILLOW (January 29, 1993)
  • K921928 — SOFT-COVER (November 6, 1992)
  • K923173 — OBALON COVER (November 6, 1992)
  • K903382 — ALLERGY CONTROL COVERS (November 2, 1990)

FDA data resources