FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NESS CHILDREN SYSTEM
K Number: K024279
·
Decision Feb 5, 2003
Classifications
1
FEI Numbers
93
Registration Numbers
93
Same Product Code
5
Applicant Total
7
Review Days
44
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Basic Information
- Device Name
- NESS CHILDREN SYSTEM
- K Number
- K024279
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3025
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ness-Neuromuscular Electrical Stimulation Systems
- Date Received
- December 23, 2002
- Decision Date
- February 5, 2003
- Product Code
- IPG
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IPG | Shoe, Cast | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IPG), ordered by most recent decision date.
TOGUARD
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CAST SHOE
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EQUALIZER
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ROCKER-SOLE CAST SANDAL
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BALANCED CAST SOLE
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Other Clearances by Ness-Neuromuscular Electrical Stimulation Systems
| K Number | Device Name | ||
|---|---|---|---|
| K111767 | NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT | Sep 15, 2011 | Substantially Equivalent |
| K080219 | MODIFICATION TO:NESS L300 | Feb 28, 2008 | Substantially Equivalent |
| K053468 | NESS L300 | Jul 7, 2006 | Substantially Equivalent |
| K031900 | HANDMASTER | Aug 8, 2003 | Substantially Equivalent |
| K022776 | NESS SYSTEM | Sep 11, 2002 | Substantially Equivalent |
| K012823 | MODIFICATION TO HANDMASTER | Nov 14, 2001 | Substantially Equivalent |