FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VERA
K Number: K192474
·
Decision Oct 10, 2019
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
26
Applicant Total
3
Review Days
30
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Basic Information
- Device Name
- VERA
- K Number
- K192474
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 890.5360
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Reflexion Health, Inc.
- Date Received
- September 10, 2019
- Decision Date
- October 10, 2019
- Product Code
- LXJ
- 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 |
|---|---|---|---|
| LXJ | Interactive Rehabilitation Exercise Devices | FDA class 2 | Physical Medicine |
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