FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FES ORTHOSIS MODEL NO. 2000
K Number: K800380
·
Decision Mar 17, 1980
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
60
Applicant Total
60
Review Days
24
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Basic Information
- Device Name
- FES ORTHOSIS MODEL NO. 2000
- K Number
- K800380
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5810
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Empi
- Date Received
- February 22, 1980
- Decision Date
- March 17, 1980
- 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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| K070427 | DUPEL TRANSPORT IONTOPHORESIS SYSTEM | May 14, 2007 | Substantially Equivalent |
| K061650 | SELECT TENS, MODEL 4600S | Jan 22, 2007 | Substantially Equivalent |
| K041920 | INFINITY PLUS ELECTROTHERAPY SYSTEM | Jan 21, 2005 | Substantially Equivalent |
| K042057 | INFINITY ELECTROTHERAPY SYSTEM | Dec 17, 2004 | Substantially Equivalent |
| K030395 | EMPI ACTION PATCH IONTOPHORESIS SYSTEM | Apr 8, 2003 | Substantially Equivalent |
| K021100 | 300 PV COMPLETE ELECTROTHERAPY SYSTEM | Jun 18, 2002 | Substantially Equivalent |
| K991991 | DUPEL IONTOPHORESIS SYSTEM | Sep 10, 1999 | Substantially Equivalent |