MODEL INT/DL40I MICRO COMPUTER CONTROLLER FOR POWER WHEELCHAIRS
FDA 510(k) clearance K950724 · decided 1995-08-07
Clearance details
- K-number
- K950724
- Device name
- MODEL INT/DL40I MICRO COMPUTER CONTROLLER FOR POWER WHEELCHAIRS
- Applicant
- Invacare Corp.
- Decision
- Substantially Equivalent
- Date received
- 1995-02-16
- Decision date
- 1995-08-07
- Days to decision
- 172 days
- Clearance type
- Traditional
- Product code
- ITI
- Device class
- 2
- Regulation number
- 890.3860
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Elyria, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.