STARBAND
FDA 510(k) clearance K082950 · decided 2008-12-05
Clearance details
- K-number
- K082950
- Device name
- STARBAND
- Applicant
- Orthomerica Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-10-03
- Decision date
- 2008-12-05
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- OAN
- Device class
- 2
- Regulation number
- 882.5970
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Orlando, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DOC Band 3D (K244056) | Cranial Technologies, Inc. | 2025-03-17 |
| STARband 3D (K240466) | Orthomerica Products, Inc. | 2024-03-15 |
| STARband (K211376) | Orthomerica Products, Inc. | 2021-08-17 |
| STARband, STARlight, St. Louis Band (K203098) | Orthomerica Products, Inc. | 2021-04-27 |
| STARband, STARlight, St. Louis Band (K180109) | Orthomerica Products, Inc. | 2018-03-01 |
| St. Louis Band (K161138) | Orthomerica Products, Inc. | 2016-07-20 |
| STARband, STARlight (K151979) | Orthomerica Products, Inc. | 2015-09-18 |
| STARband, STARlight (K151147) | Orthomerica Products, Inc. | 2015-07-01 |
| STARBAND, STARLIGHT (K142141) | Orthomerica Products, Inc. | 2015-04-23 |
| STARLIGHT (K133250) | Orthomerica Products, Inc. | 2014-01-16 |
| STARBAND (K124023) | Orthomerica Products, Inc. | 2013-06-10 |
| STARLIGHT (K090587) | Orthomerica Products, Inc. | 2009-07-17 |
Recalls involving this device
No recalls on record reference this clearance.