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FDA 510(k), K163451, Action Trackstander models TR1816, TR1820, TR2016, and TR2020
FDA 510(k), K163451, Action Trackstander models TR1816, TR1820, TR2016, and TR2020
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510(K) Number: K163451
Device Name: Action Trackstander models TR1816, TR1820, TR2016, and TR2020
Manufacturer: Alan Macht
Device Classification Name: Wheelchair, Standup
Regulation Number: IPL
Classification Product Code: 12/08/2016
Date Received: 01/12/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Physical Medicine
Device Name: Action Trackstander models TR1816, TR1820, TR2016, and TR2020
Manufacturer: Alan Macht
Device Classification Name: Wheelchair, Standup
Regulation Number: IPL
Classification Product Code: 12/08/2016
Date Received: 01/12/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Physical Medicine
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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