FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEUROMOVE NM900
K Number: K012885
·
Decision Nov 8, 2001
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
547
Applicant Total
6
Review Days
72
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Basic Information
- Device Name
- NEUROMOVE NM900
- K Number
- K012885
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Dan Med, Inc.
- Date Received
- August 28, 2001
- Decision Date
- November 8, 2001
- 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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| K Number | Device Name | ||
|---|---|---|---|
| K013210 | TRUWAVE | Apr 4, 2002 | Substantially Equivalent |
| K010745 | EMS 3000 | Jun 27, 2001 | Substantially Equivalent |
| K991241 | IF8000 | Nov 2, 1999 | Substantially Equivalent |
| K972997 | AM800 AUTOMOVE EMG TRIGGERED ELECTRICAL MUSCLE STIMULATION | Nov 10, 1997 | Substantially Equivalent |
| K964738 | ELPHA 2000 CONTI | Aug 14, 1997 | Substantially Equivalent |