SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 AND SL 801 MECHANICAL WHEELCHAIRS
FDA 510(k) clearance K020100 · decided 2002-03-08
Clearance details
- K-number
- K020100
- Device name
- SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 AND SL 801 MECHANICAL WHEELCHAIRS
- Applicant
- Regulatory Insight, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-01-11
- Decision date
- 2002-03-08
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- IOR
- Device class
- 1
- Regulation number
- 890.3850
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Littleton, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.