SKYWAY
FDA 510(k) clearance K964682 · decided 1997-01-13
Clearance details
- K-number
- K964682
- Device name
- SKYWAY
- Applicant
- Kid'S Wheel-Chairs
- Decision
- Substantially Equivalent
- Date received
- 1996-11-22
- Decision date
- 1997-01-13
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- IOR
- Device class
- 1
- Regulation number
- 890.3850
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- St. Petersburg, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.