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510(k) K152884

DermaTherapy Bed Linens by Precision Fabrics Group, Inc. — Product Code FMW

K152884 is an FDA 510(k) premarket notification submitted by Precision Fabrics Group, Inc. for the device "DermaTherapy Bed Linens". The FDA issued a decision of Substantially Equivalent on June 20, 2016. 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
June 20, 2016
Date Received
September 30, 2015
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.

  • K061242 — DERMATHERAPY, MODEL 22216 (January 25, 2007)

Other clearances for product code FMW

  • K061242 — DERMATHERAPY, MODEL 22216 (January 25, 2007)
  • 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