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FDA 510(k), K190038, Xbody Newave USA
FDA 510(k), K190038, Xbody Newave USA
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$89.00 USD
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510(K) Number: K190038
Device Name: Xbody Newave USA
Manufacturer: XBody Hungary Kft.
Device Classification Name: stimulator, muscle, powered, for muscle conditioning
Regulation Number: 890.5850
Classification Product Code: NGX
Date Received: 01/08/2019
Decision Date: 04/05/2019
Regulation Medical Specialty: Physical Medicine
Device Name: Xbody Newave USA
Manufacturer: XBody Hungary Kft.
Device Classification Name: stimulator, muscle, powered, for muscle conditioning
Regulation Number: 890.5850
Classification Product Code: NGX
Date Received: 01/08/2019
Decision Date: 04/05/2019
Regulation Medical Specialty: Physical Medicine
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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