The following data is part of a premarket notification filed by Alter-g, Inc. with the FDA for G-trainer Medical.
Device ID | K072887 |
510k Number | K072887 |
Device Name: | G-TRAINER MEDICAL |
Classification | Exerciser, Powered |
Applicant | ALTER-G, INC. 1090A O'BRIEN DRIVE Menlo Park, CA 94025 |
Contact | Glen Mangseth |
Correspondent | Glen Mangseth ALTER-G, INC. 1090A O'BRIEN DRIVE Menlo Park, CA 94025 |
Product Code | BXB |
CFR Regulation Number | 890.5380 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-10-10 |
Decision Date | 2008-01-25 |
Summary: | summary |