FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE
K Number: K063465
·
Decision Feb 28, 2007
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
72
Applicant Total
17
Review Days
104
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Basic Information
- Device Name
- CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE
- K Number
- K063465
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5525
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Iomed, Inc.
- Date Received
- November 16, 2006
- Decision Date
- February 28, 2007
- Product Code
- EGJ
- 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 |
|---|---|---|---|
| EGJ | Device, Iontophoresis, Other Uses | FDA class 2 | Physical Medicine |
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Other Clearances by Iomed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K060236 | MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE | Mar 31, 2006 | Substantially Equivalent |
| K033192 | RH-950 | Dec 22, 2003 | Substantially Equivalent |
| K031115 | RH-900 | Jul 10, 2003 | Substantially Equivalent |
| K001522 | TRANSQ3 | Oct 18, 2000 | Substantially Equivalent |
| K001410 | PHORESOR MODEL PM2000 | Aug 1, 2000 | Substantially Equivalent |
| K982668 | PHORESOR II,MODEL PM900 | Mar 2, 1999 | Substantially Equivalent |
| K974855 | PHORESOR II, MODEL PM900 | Mar 27, 1998 | Substantially Equivalent for Some Indications |
| K954126 | TRANSQ ELECTRODE PHORESOR II | Jan 19, 1996 | Substantially Equivalent for Some Indications |
| K934335 | PHORESOR II AUTO, MODEL PM800 MODIFICATION | Jul 26, 1994 | Substantially Equivalent |
| K932621 | RH-801/GS MODEL TRANSQ(R)1 | Jul 26, 1994 | Substantially Equivalent |