SmartDrive Wheelchair Power Assist
FDA 510(k) clearance K151199 · decided 2015-07-30
Clearance details
- K-number
- K151199
- Device name
- SmartDrive Wheelchair Power Assist
- Applicant
- Max Mobility, LLC
- Decision
- Substantially Equivalent
- Date received
- 2015-05-05
- Decision date
- 2015-07-30
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- ITI
- Device class
- 2
- Regulation number
- 890.3860
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Antioch, TN, US
- Third-party review
- Yes
- Expedited review
- No
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