ViMove2
FDA 510(k) K163150 · Dorsavi, Ltd.
510(k) numberK163150
Submission
- Device name
- ViMove2
- Applicant
- Dorsavi, Ltd.
East Melbourne, AU - Received
- November 9, 2016
- Decision date
- July 14, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IKN – Electromyograph, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.1375
- Specialty
- Physical Medicine
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| K142494 | ViMoveIKN · Traditional | Dorsavi, Ltd. | 05/28/2015SE |
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More from Uroval
| 510(k) | Device | Decision |
|---|---|---|
| K142494 | ViMoveIKN · Traditional | 05/28/2015SE |
Questions and answers
When was ViMove2 cleared by the FDA?
ViMove2 (K163150) received a 510(k) decision of Substantially Equivalent on July 14, 2017, 247 days after the submission was received.
What is the product code of K163150?
The FDA product code is IKN – Electromyograph, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 890.1375.