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FDA 510(k), K191151, JKH Stimulator Plus
FDA 510(k), K191151, JKH Stimulator Plus
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$89.00 USD
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510(K) Number: K191151
Device Name: JKH Stimulator Plus
Manufacturer: JKH USA, LLC
Device Classification Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter
Regulation Number: 882.5890
Classification Product Code: NUH
Date Received: 05/01/2019
Decision Date: 06/21/2019
Regulation Medical Specialty: Neurology
Device Name: JKH Stimulator Plus
Manufacturer: JKH USA, LLC
Device Classification Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter
Regulation Number: 882.5890
Classification Product Code: NUH
Date Received: 05/01/2019
Decision Date: 06/21/2019
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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