Ness Children System
FDA 510(k) K024279 · Ness-Neuromuscular Electrical Stimulation Systems
510(k) numberK024279
Submission
- Device name
- Ness Children System
- Applicant
- Ness-Neuromuscular Electrical Stimulation Systems
Washington, DC, US - Received
- December 23, 2002
- Decision date
- February 5, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IPG – Shoe, Cast
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3025
- Specialty
- Physical Medicine
Other 510(k)s with product code IPG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K790652 | ToguardIPG · Traditional | Togard, Inc. | 04/04/1979SE |
| K781363 | Cast ShoeIPG · Traditional | Cutler Biomedical | 08/14/1978SE |
| K780617 | EqualizerIPG · Traditional | Ballert Orthopedic Corp. | 04/18/1978SE |
| K760575 | Rocker-Sole Cast SandalIPG · Traditional | Richard'S Medical Equip., Inc. | 10/06/1976SE |
| K760578 | Balanced Cast SoleIPG · Traditional | Parke-Davis Co. | 09/27/1976SE |
More from Parke-Davis Co.
| 510(k) | Device | Decision |
|---|---|---|
| K111767 | Ness H200 Wireless Hand Rehabilitation System User Kit and Clinican KitGZI · Traditional | 09/15/2011SE |
| K080219 | Modification To:Ness L300GZI · Special | 02/28/2008SE |
| K053468 | Ness L300GZI · Traditional | 07/07/2006SE |
| K031900 | HandmasterGZI · Special | 08/08/2003SE |
| K022776 | Ness SystemIPF · Special | 09/11/2002SE |
| K012823 | Modification to HandmasterGZI · Traditional | 11/14/2001SE |
Questions and answers
When was Ness Children System cleared by the FDA?
Ness Children System (K024279) received a 510(k) decision of Substantially Equivalent on February 5, 2003, 44 days after the submission was received.
What is the product code of K024279?
The FDA product code is IPG – Shoe, Cast, a Class I (low risk) device regulated under 21 CFR 890.3025.