HIROLLER ELEVATING WHEELCHAIR
FDA 510(k) clearance K102837 · decided 2010-12-23
Clearance details
- K-number
- K102837
- Device name
- HIROLLER ELEVATING WHEELCHAIR
- Applicant
- Max Mobility, LLC
- Decision
- Substantially Equivalent
- Date received
- 2010-09-29
- Decision date
- 2010-12-23
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- IPL
- Device class
- 2
- Regulation number
- 890.3900
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Antioch, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.