Orion
FDA 510(k) clearance K200529 · decided 2020-08-12
Clearance details
- K-number
- K200529
- Device name
- Orion
- Applicant
- Interacoustics A/S
- Decision
- Substantially Equivalent
- Date received
- 2020-03-02
- Decision date
- 2020-08-12
- Days to decision
- 163 days
- Clearance type
- Traditional
- Product code
- LXV
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Middelfart, DK
- 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 |
|---|---|---|
| GyroStim (K220231) | Ultrathera Technologies, Inc. | 2022-04-27 |
| TRV (K192652) | Interacoustics A/S | 2020-05-27 |
| ClearEdge Balance System (K183661) | Quadrant Biosciences | 2019-10-22 |
| EQ Balance (K190735) | Upright Science, Inc. | 2019-08-16 |
| K-D Balance (K173669) | King-Devick Technologies, Inc. | 2018-04-02 |
| VESTIBULAR ANALYSIS APPARATUS (K121590) | Capacity Sports, LLC | 2012-09-20 |
| NYDIAG 200 (K102364) | Interacoustics A/S | 2010-12-23 |
| VERTIGONE BPPV GOGGLE (K082634) | Vertigone, Inc. | 2009-04-07 |
| DIZZYFIX (K081602) | Clearwater Clinical Limited | 2008-09-19 |
| EPLEY OMNIAX (K071973) | Vesticon | 2008-06-20 |
| KOREBALANCE (KINESTHETIC ABILITY TRAINER) (K070676) | Sportkat, LLC | 2007-04-18 |
| BALANCE REHABILITATION UNIT (BRU) (K070085) | Medicaa (Uruguay) S.A. | 2007-02-26 |
Recalls involving this device
No recalls on record reference this clearance.