Walking Aid

FDA 510(k) K772049 · Guardian Products Co., Inc.

Substantially Equivalent

510(k) numberK772049

Submission

Device name
Walking Aid
Applicant
Guardian Products Co., Inc.
Mchenry, IL, US
Received
October 31, 1977
Decision date
November 11, 1977
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
ITJ – Walker, Mechanical
Device class
Class I (low risk)
Regulation
21 CFR 890.3825
Specialty
Physical Medicine

Other 510(k)s with product code ITJ

510(k)DeviceApplicantDecision
K833869Child's WalkerITJ · Traditional Kaye Products, Inc.11/29/1983SE
K833195Umbrella WalkerITJ · Traditional Convaid Products, Inc.10/27/1983SE
K830784Walk N RollITJ · Traditional Meta-Morris05/25/1983SE
K830848Resi-WalkerITJ · Traditional Lic-Orthion04/05/1983SE
K823105Resi-WalkerITJ · Traditional Orthion Corp.11/05/1982SE
K821404Light Weight Aluminum WalkerITJ · Traditional Manuco Manufacturing Co., Inc.05/21/1982SE
K820711Walk-A-CycleITJ · Traditional Walk-A-Cycle Division04/08/1982SE
K811485Walker/Crutch BagITJ · Traditional Fred Sammons, Inc.06/16/1981SE
K792064Delta Rolling Self-Licking WalkerITJ · Traditional Staricat, Inc.10/30/1979SE
K790529Walking AidITJ · Traditional Maddak, Inc.04/03/1979SE

More from Maddak, Inc.

510(k)DeviceDecision
K915108Folding WheelchairIOR · Traditional 01/13/1992SE
K842650Wall Grab Bars 98130-98136IKX · Traditional 08/10/1984SE
K842649Bath Tub Transfer ChairIKN · Traditional 08/10/1984SE
K842651Commode Chair 98200ILS · Traditional 08/07/1984SE
K821010Bathtub Transfer BenchIKX · Traditional 04/21/1982SE
K821009Bathtub Grab BarILS · Traditional 04/21/1982SE
K790299Forearm-CaneIPS · Traditional 02/21/1979SE

Questions and answers

When was Walking Aid cleared by the FDA?

Walking Aid (K772049) received a 510(k) decision of Substantially Equivalent on November 11, 1977, 11 days after the submission was received.

What is the product code of K772049?

The FDA product code is ITJ – Walker, Mechanical, a Class I (low risk) device regulated under 21 CFR 890.3825.