Teknique
510(k) K010075
Teknique is a medical device (FDA Class II; FDA product code ITI, Wheelchair, Powered) made by Hoveround Corp., cleared under FDA 510(k) K010075 on 14 Feb 2001, 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 | NumberK010075 | Date14 Feb 2001 | StatusActive |
Official records
- FDA 510(k) database K010075
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ITI
- Device class
- Class II
- Regulation
- 21 CFR Part 890.3860
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
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- JAZZY FRONTIE by Pride Mobility Products Corporation
- CHIPS POWERED WHEELCHAIR by International Healthcare Solutions, Inc.
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- INVACARE 3G TARSYS by Invacare Corp.
- PREMIER by Everest & Jennings, Inc.