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 |