FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MAXEMS, MODELS 1000 AND 2000
K Number: K091248
·
Decision Nov 30, 2009
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
547
Applicant Total
17
Review Days
216
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Basic Information
- Device Name
- MAXEMS, MODELS 1000 AND 2000
- K Number
- K091248
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bio Protech, Inc.
- Date Received
- April 28, 2009
- Decision Date
- November 30, 2009
- Product Code
- IPF
- 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 |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | FDA class 2 | Physical Medicine |
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