510(k) K024279

NESS CHILDREN SYSTEM by Ness-Neuromuscular Electrical Stimulation Systems — Product Code IPG

K024279 is an FDA 510(k) premarket notification submitted by Ness-Neuromuscular Electrical Stimulation Systems for the device "NESS CHILDREN SYSTEM". The FDA issued a decision of Substantially Equivalent on February 5, 2003. The device falls under product code IPG (Shoe, Cast), a Class I device regulated under 21 CFR 890.3025. Ness-Neuromuscular Electrical Stimulation Systems has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2003
Date Received
December 23, 2002
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