The following data is part of a premarket notification filed by Actigraph, Llc with the FDA for Actitrainer.
| Device ID | K080545 |
| 510k Number | K080545 |
| Device Name: | ACTITRAINER |
| Classification | Exerciser, Measuring |
| Applicant | ACTIGRAPH, LLC 15 W. MAIN. ST Pensacola, FL 32502 |
| Contact | John Scheider |
| Correspondent | John Scheider ACTIGRAPH, LLC 15 W. MAIN. ST Pensacola, FL 32502 |
| Product Code | ISD |
| CFR Regulation Number | 890.5360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-27 |
| Decision Date | 2008-07-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853048008015 | K080545 | 000 |
| 00853048008008 | K080545 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ACTITRAINER 77179470 not registered Dead/Abandoned |
ActiGraph, LLC 2007-05-12 |