The following data is part of a premarket notification filed by Emovi with the FDA for Kneekg.
Device ID | K091000 |
510k Number | K091000 |
Device Name: | KNEEKG |
Classification | Interactive Rehabilitation Exercise Devices |
Applicant | EMOVI 1100,BOUL. RENE-LEVESQUE OUEST 25 FIFTH FLOOR Montreal, Quebec, CA H3b 5c9 |
Contact | Emmanuel Montini |
Correspondent | Emmanuel Montini EMOVI 1100,BOUL. RENE-LEVESQUE OUEST 25 FIFTH FLOOR Montreal, Quebec, CA H3b 5c9 |
Product Code | LXJ |
CFR Regulation Number | 890.5360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-04-08 |
Decision Date | 2009-10-26 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00627843933236 | K091000 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
KNEEKG 88842640 not registered Live/Pending |
Emovi Inc. 2020-03-20 |