Activa
510(k) K991132
Activa is a medical device (FDA Class II; FDA product code INI, Vehicle, Motorized 3-Wheeled) made by Hoveround Corp., cleared under FDA 510(k) K991132 on 20 Oct 1999, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK991132 | Date20 Oct 1999 | StatusActive |
Official records
- FDA 510(k) database K991132
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- INI
- Device class
- Class II
- Regulation
- 21 CFR Part 890.3800
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
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- TMC ELECTRICAL SCOOTER, EASY 321 by Tmc Technology Corp.
- FORTRESS MODEL 2001LX ELECTRIC 3-WHEELER by Fortress Scientific, Ltd.
- SCOOTER, VEHICLE MOTORIZED by Amigo Sales, Inc.