510(k) K963455

SLEEVED JACKET/SLEEVED JACKET WITH SLIDER CONTROL by Skil-Care Corp. — Product Code KID

K963455 is an FDA 510(k) premarket notification submitted by Skil-Care Corp. for the device "SLEEVED JACKET/SLEEVED JACKET WITH SLIDER CONTROL". The FDA issued a decision of Substantially Equivalent on October 8, 1996. The device falls under product code KID (Restraint, Wheelchair, Non-Protective), a Class I device regulated under 21 CFR 890.3910. Skil-Care Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 1996
Date Received
September 3, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Restraint, Wheelchair, Non-Protective
Device Class
Class I
Regulation Number
890.3910
Review Panel
PM
Submission Type