The following data is part of a premarket notification filed by Ivivi Health Science, Llc with the FDA for Zeobi.
Device ID | K121338 |
510k Number | K121338 |
Device Name: | ZEOBI |
Classification | Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat |
Applicant | IVIVI HEALTH SCIENCE, LLC 330 TOWNSEND STREET SUITE 100 San Francisco, CA 94107 |
Contact | Kathryn Clubb |
Correspondent | Kathryn Clubb IVIVI HEALTH SCIENCE, LLC 330 TOWNSEND STREET SUITE 100 San Francisco, CA 94107 |
Product Code | ILX |
CFR Regulation Number | 890.5290 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-05-03 |
Decision Date | 2012-07-27 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ZEOBI 85641049 not registered Dead/Abandoned |
IVIVI HEALTH SCIENCES, LLC 2012-06-01 |