ACTIVA
FDA 510(k) clearance K991132 · decided 1999-10-20
Clearance details
- K-number
- K991132
- Device name
- ACTIVA
- Applicant
- Hoveround Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-04-02
- Decision date
- 1999-10-20
- Days to decision
- 201 days
- Clearance type
- Traditional
- Product code
- INI
- Device class
- 2
- Regulation number
- 890.3800
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Sarasota, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.