510(k) K024279
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