510(k) K760575

ROCKER-SOLE CAST SANDAL by Richard'S Medical Equip., Inc. — Product Code IPG

K760575 is an FDA 510(k) premarket notification submitted by Richard'S Medical Equip., Inc. for the device "ROCKER-SOLE CAST SANDAL". The FDA issued a decision of Substantially Equivalent on October 6, 1976. The device falls under product code IPG (Shoe, Cast), a Class I device regulated under 21 CFR 890.3025. Richard'S Medical Equip., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1976
Date Received
September 3, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shoe, Cast
Device Class
Class I
Regulation Number
890.3025
Review Panel
PM
Submission Type