The following data is part of a premarket notification filed by Physiomed Elektromedizin Ag with the FDA for Bodyflow P2ch.
Device ID | K100862 |
510k Number | K100862 |
Device Name: | BODYFLOW P2CH |
Classification | Stimulator, Muscle, Powered |
Applicant | PHYSIOMED ELEKTROMEDIZIN AG HUTWEIDE 10 Schnaittach/laipersdorf, DE D-91220 |
Contact | Birgit Schmid |
Correspondent | Birgit Schmid PHYSIOMED ELEKTROMEDIZIN AG HUTWEIDE 10 Schnaittach/laipersdorf, DE D-91220 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-03-29 |
Decision Date | 2011-04-21 |
Summary: | summary |