PANTHERA MECHANICAL WHEELCHAIR, MODELS S2, U2, BAMBINO, MICRO, BT
FDA 510(k) clearance K083231 · decided 2009-01-26
Clearance details
- K-number
- K083231
- Device name
- PANTHERA MECHANICAL WHEELCHAIR, MODELS S2, U2, BAMBINO, MICRO, BT
- Applicant
- Panthera Production AB
- Decision
- Substantially Equivalent
- Date received
- 2008-11-03
- Decision date
- 2009-01-26
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- IOR
- Device class
- 1
- Regulation number
- 890.3850
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.