FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STAODYN MAX PRESET, MODEL 4470
K Number: K061516
·
Decision Feb 6, 2007
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
2
Review Days
250
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Basic Information
- Device Name
- STAODYN MAX PRESET, MODEL 4470
- K Number
- K061516
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Compex Technologies, Inc.
- Date Received
- June 1, 2006
- Decision Date
- February 6, 2007
- 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 Compex Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K050046 | REHABILICARE IF 3 WAVE INTERFERENTIAL STIMULATOR SYSTEM, MODEL 7110S | Apr 13, 2005 | Substantially Equivalent |