ZEOBI
FDA 510(k) clearance K121338 · decided 2012-07-27
Clearance details
- K-number
- K121338
- Device name
- ZEOBI
- Applicant
- Ivivi Health Science, LLC
- Decision
- Substantially Equivalent
- Date received
- 2012-05-03
- Decision date
- 2012-07-27
- Days to decision
- 85 days
- Clearance type
- Special
- Product code
- ILX
- Device class
- 2
- Regulation number
- 890.5290
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
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| ORTHOCOR KNEE SYSTEM BASIC (K091996) | Orthocor Medical | 2009-12-15 |
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| MODEL PMT850 (K070931) | Promedtek, Inc. | 2007-05-24 |
| ACTIBAND (K022404) | Paw, LLC | 2002-08-08 |
| REGENESIS MODEL 42 (K972093) | Regenesis Biomedical, Inc. | 1997-10-21 |
Recalls involving this device
No recalls on record reference this clearance.