FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT
K Number: K111767
·
Decision Sep 15, 2011
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
60
Applicant Total
7
Review Days
84
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Basic Information
- Device Name
- NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT
- K Number
- K111767
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5810
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ness-Neuromuscular Electrical Stimulation Systems
- Date Received
- June 23, 2011
- Decision Date
- September 15, 2011
- Product Code
- GZI
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GZI | Stimulator, Neuromuscular, External Functional | FDA class 2 | Neurology |
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Other Clearances by Ness-Neuromuscular Electrical Stimulation Systems
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K024279 | NESS CHILDREN SYSTEM | Feb 5, 2003 | Substantially Equivalent |
| K022776 | NESS SYSTEM | Sep 11, 2002 | Substantially Equivalent |
| K012823 | MODIFICATION TO HANDMASTER | Nov 14, 2001 | Substantially Equivalent |