510(k) K831149

PERSONAL KNEE CRUTCH PAD by Tecnol New Jersey Wound Care, Inc. — Product Code INP

K831149 is an FDA 510(k) premarket notification submitted by Tecnol New Jersey Wound Care, Inc. for the device "PERSONAL KNEE CRUTCH PAD". The FDA issued a decision of Substantially Equivalent on May 3, 1983. The device falls under product code INP (Tips And Pads, Cane, Crutch And Walker), a Class I device regulated under 21 CFR 890.3790. Tecnol New Jersey Wound Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1983
Date Received
April 8, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tips And Pads, Cane, Crutch And Walker
Device Class
Class I
Regulation Number
890.3790
Review Panel
PM
Submission Type