Toguard

FDA 510(k) K790652 · Togard, Inc.

Substantially Equivalent

510(k) numberK790652

Submission

Device name
Toguard
Applicant
Togard, Inc.
Mchenry, IL, US
Received
April 4, 1979
Decision date
April 4, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IPG – Shoe, Cast
Device class
Class I (low risk)
Regulation
21 CFR 890.3025
Specialty
Physical Medicine

Other 510(k)s with product code IPG

510(k)DeviceApplicantDecision
K024279Ness Children SystemIPG · Traditional Ness-Neuromuscular Electrical Stimulation Systems02/05/2003SE
K781363Cast ShoeIPG · Traditional Cutler Biomedical08/14/1978SE
K780617EqualizerIPG · Traditional Ballert Orthopedic Corp.04/18/1978SE
K760575Rocker-Sole Cast SandalIPG · Traditional Richard'S Medical Equip., Inc.10/06/1976SE
K760578Balanced Cast SoleIPG · Traditional Parke-Davis Co.09/27/1976SE

Questions and answers

When was Toguard cleared by the FDA?

Toguard (K790652) received a 510(k) decision of Substantially Equivalent on April 4, 1979, 0 days after the submission was received.

What is the product code of K790652?

The FDA product code is IPG – Shoe, Cast, a Class I (low risk) device regulated under 21 CFR 890.3025.