TACAMO MANUAL WHEELCHAIR
FDA 510(k) clearance K101719 · decided 2010-08-25
Clearance details
- K-number
- K101719
- Device name
- TACAMO MANUAL WHEELCHAIR
- Applicant
- Dalton Instrument Corp.
- Decision
- Substantially Equivalent
- Date received
- 2010-06-18
- Decision date
- 2010-08-25
- Days to decision
- 68 days
- Clearance type
- Abbreviated
- Product code
- IOR
- Device class
- 1
- Regulation number
- 890.3850
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Addiison, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.