FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EMPI, MODEL 489, TENS
K Number: K890604
·
Decision Jun 1, 1989
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
60
Review Days
115
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Basic Information
- Device Name
- EMPI, MODEL 489, TENS
- K Number
- K890604
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Empi
- Date Received
- February 6, 1989
- Decision Date
- June 1, 1989
- Product Code
- GZJ
- 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 |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | FDA class 2 | Neurology |
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Other Clearances by Empi
| K Number | Device Name | ||
|---|---|---|---|
| K093324 | EMPI CONTINUUM | Mar 5, 2010 | Substantially Equivalent |
| K090922 | EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR | Jun 5, 2009 | Substantially Equivalent |
| K072946 | HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM | Nov 16, 2007 | Substantially Equivalent |
| 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 |