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 |