LUMEX WHEELCHAIRS (SER. 1000, 3000, 4000, 5000, TILT-IN-SPACE, 6000, MRI)
FDA 510(k) clearance K944574 · decided 1994-10-17
Clearance details
- K-number
- K944574
- Device name
- LUMEX WHEELCHAIRS (SER. 1000, 3000, 4000, 5000, TILT-IN-SPACE, 6000, MRI)
- Applicant
- Lumex, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-09-19
- Decision date
- 1994-10-17
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- IOR
- Device class
- 1
- Regulation number
- 890.3850
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Bay Shore, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.