Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T, FL13T, FL14T, FL15T and FL16T
FDA 510(k) clearance K171017 · decided 2017-10-18
Clearance details
- K-number
- K171017
- Device name
- Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T, FL13T, FL14T, FL15T and FL16T
- Applicant
- Convaid Products, LLC
- Decision
- Substantially Equivalent
- Date received
- 2017-04-05
- Decision date
- 2017-10-18
- Days to decision
- 196 days
- Clearance type
- Traditional
- Product code
- IOR
- Device class
- 1
- Regulation number
- 890.3850
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Torrance, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.