FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PREMIER PLUS
K Number: K032003
·
Decision Jan 7, 2004
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
11
Review Days
194
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PREMIER PLUS
- K Number
- K032003
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- American Imex
- Date Received
- June 27, 2003
- Decision Date
- January 7, 2004
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GZJ), ordered by most recent decision date.
STIMPOD NMS460 Nerve Stimulator
FDA 510(k)
FDA Class 2
·Neurology
actiTENS mini
FDA 510(k)
FDA Class 2
·Neurology
CP Relief Wand Rx - TENS/NMES
FDA 510(k)
FDA Class 2
·Neurology
Unipro (K-UNIPRO-US)
FDA 510(k)
FDA Class 2
·Neurology
TENSWave
FDA 510(k)
FDA Class 2
·Neurology
Electrical Neuromuscular Stimulator, Cure Trio
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by American Imex
| K Number | Device Name | ||
|---|---|---|---|
| K982221 | PREMIER AP | Sep 22, 1998 | Substantially Equivalent |
| K926326 | MICROCARE(TM) | Jun 1, 1993 | Substantially Equivalent |
| K912289 | ULTIMA XS, MODIFICATION | Nov 22, 1991 | Substantially Equivalent |
| K895295 | ULTIMA XS MICROCURRENT TENS | Nov 6, 1989 | Substantially Equivalent |
| K894388 | ZIMMER TENS | Aug 10, 1989 | Substantially Equivalent |
| K881704 | EASY TENS | May 4, 1988 | Substantially Equivalent |
| K881424 | PREMIER 10S (TENS) | Apr 11, 1988 | Substantially Equivalent |
| K880751 | ULTIMA XS (TENS) | Apr 6, 1988 | Substantially Equivalent |
| K864735 | A-TENS - MODEL AI-87 | Feb 20, 1987 | Substantially Equivalent |
| K861709 | A TENS (MODEL AI-86) | May 16, 1986 | Substantially Equivalent |