Cersa-Cane

FDA 510(k) K790558 · Maddak, Inc.

Substantially Equivalent

510(k) numberK790558

Submission

Device name
Cersa-Cane
Applicant
Maddak, Inc.
Mchenry, IL, US
Received
March 19, 1979
Decision date
April 3, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IPS – Cane
Device class
Class I (low risk)
Regulation
21 CFR 890.3075
Specialty
Physical Medicine

Other 510(k)s with product code IPS

510(k)DeviceApplicantDecision
K832970Cane ReacherIPS · Traditional Maddak, Inc.09/29/1983SE
K832969Walking CaneIPS · Traditional Maddak, Inc.09/29/1983SE
K821402Light Weight Aluminum CanesIPS · Traditional Manuco Manufacturing Co., Inc.04/21/1982SE
K790561Offset Aluminum CaneIPS · Traditional Maddak, Inc.04/03/1979SE
K790299Forearm-CaneIPS · Traditional Guardian Products Co., Inc.02/21/1979SE
K780085Cane/ReacherIPS · Traditional Fred Sammons, Inc.01/30/1978SE
K772267Quadraplegic Walking AidIPS · Traditional Med Fusion Systems, Inc.12/20/1977SE
K770529Unicet IIPS · Traditional Union Carbide Corp.04/05/1977SE

More from Union Carbide Corp.

510(k)DeviceDecision
K841700Walk & RollINM · Traditional 05/11/1984SE
K841698Heat PackIMA · Traditional 05/10/1984SE
K841695CrawlerKNL · Traditional 05/10/1984SE
K841697Hydro-Thero PadIRT · Traditional 05/09/1984SE
K841693Standing Frame · Traditional 05/09/1984SE
K841692Prone Stander · Traditional 05/09/1984SE
K841691Split Seat Positioning ChairINN · Traditional 05/09/1984SE
K834311Night TrainerKPN · Traditional 03/30/1984SE
K833870Knee WalkerION · Traditional 11/29/1983SE
K833177Glossectomy Feeding SpoonsILC · Traditional 10/31/1983SE

Questions and answers

When was Cersa-Cane cleared by the FDA?

Cersa-Cane (K790558) received a 510(k) decision of Substantially Equivalent on April 3, 1979, 15 days after the submission was received.

What is the product code of K790558?

The FDA product code is IPS – Cane, a Class I (low risk) device regulated under 21 CFR 890.3075.