The Smithcot

FDA 510(k) K896261 · Ram Marketing, Inc.

Substantially Equivalent

510(k) numberK896261

Submission

Device name
The Smithcot
Applicant
Ram Marketing, Inc.
Greensburg, PA, US
Received
October 30, 1989
Decision date
December 22, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FPP – Stretcher, Hand-Carried
Device class
Class I (low risk)
Regulation
21 CFR 880.6900
Specialty
General Hospital

Other 510(k)s with product code FPP

510(k)DeviceApplicantDecision
K030283Baby PodFPP · Traditional Prism Enterprises, Inc.04/22/2003SE
K942356MED-EVAC-4 Medical Evacuation StretcherFPP · Traditional Montery Bay Corp.07/19/1994SE
K940130Stryker Model 6110 Emergency/Pole StretcherFPP · Traditional Stryker Corp.03/10/1994SE
K940245Evacu-SledFPP · Traditional Evacu Technologies, Inc.02/28/1994SE
K924275Restraining StretcherFPP · Traditional Dms07/27/1993SE
K922816U P Custom Design, Inc. Cot Equipment CarrierFPP · Traditional Up Custom Design, Inc.07/13/1993SE
K924669Ferno-Washington Basket Stretcher, Model 71-WFPP · Traditional Ferno04/29/1993SE
K920805Life Lite Emergency StretcherFPP · Traditional Design Principles, Inc.05/22/1992SE
K915874Basket Litter CarrierFPP · Traditional Bradco Med , Ltd.05/13/1992SE
K914140Grassi Gastrojejun Tube Gastric Decomp/Jejun FeedFPP · Traditional Bissell Medical Products, Inc.03/31/1992SE

Questions and answers

When was The Smithcot cleared by the FDA?

The Smithcot (K896261) received a 510(k) decision of Substantially Equivalent on December 22, 1989, 53 days after the submission was received.

What is the product code of K896261?

The FDA product code is FPP – Stretcher, Hand-Carried, a Class I (low risk) device regulated under 21 CFR 880.6900.