ViMove2
FDA 510(k) clearance K163150 · decided 2017-07-14
Clearance details
- K-number
- K163150
- Device name
- ViMove2
- Applicant
- Dorsavi, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2016-11-09
- Decision date
- 2017-07-14
- Days to decision
- 247 days
- Clearance type
- Special
- Product code
- IKN
- Device class
- 2
- Regulation number
- 890.1375
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- East Melbourne, AU
- 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 |
|---|---|---|
| Natus VikingQuest (K172743) | Natus Neurology Incorporated | 2017-12-19 |
| Cadwell Sierra Summit, Cadwell Sierra Ascent (K162383) | Cadwell Industries, Inc. | 2017-03-01 |
| ViMove (K142494) | Dorsavi, Ltd. | 2015-05-28 |
| VIMOVE (K131094) | Dorsa VI Pty., Ltd. | 2014-07-11 |
| PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S) (K123902) | Oktx, LLC | 2013-09-13 |
| MYOVISION 3.0 WIREFREE SYSTEM (K123399) | Precision Biometrics, Inc. | 2013-08-01 |
| CMAP PRO (K113074) | Medical Technologies, Inc. | 2012-02-02 |
| FOCUS EMG DEVICE (K102610) | Teleemg, LLC USA | 2011-03-04 |
| CERSR ELECTROMYOGRAPHY SYSTEM (K110048) | Spinematrix, Inc. | 2011-01-26 |
| UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1 (K083679) | Uroval | 2009-09-11 |
| NEMUS SYSTEM; NEMUS PC PERIPHERAL (K073415) | Eb Neuro S.P.A. | 2008-05-23 |
| INSIGHT DISCOVERY (K063447) | Fasstech | 2007-08-16 |
Recalls involving this device
No recalls on record reference this clearance.