Actitrainer
510(k) K080545
Actitrainer is a medical device (FDA Class II; FDA product code ISD, Exerciser, Measuring) made by Actigraph, LLC, cleared under FDA 510(k) K080545 on 24 Jul 2008, 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 | NumberK080545 | Date24 Jul 2008 | StatusActive |
Official records
- FDA 510(k) database K080545
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ISD
- Device class
- Class II
- Regulation
- 21 CFR Part 890.5360
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K080545
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| ActiGraph GT9X | GT9X | 00853048008015 | — | On the market |
| Actigraph wGT3X-BT | wGT3X-BT | 00853048008008 | — | On the market |
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