BALANCEBACK MOBILE INTUITIVE VNG SYSTEM
FDA 510(k) clearance K070729 · decided 2007-03-30
Clearance details
- K-number
- K070729
- Device name
- BALANCEBACK MOBILE INTUITIVE VNG SYSTEM
- Applicant
- Fall Prevention Technologies, LLC
- Decision
- Substantially Equivalent
- Date received
- 2007-03-15
- Decision date
- 2007-03-30
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- GWN
- Device class
- 2
- Regulation number
- 882.1460
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Kettering, OH, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.