FDA 510(k), K163451, Action Trackstander models TR1816, TR1820, TR2016, and TR2020
FDA 510(k), K163451, Action Trackstander models TR1816, TR1820, TR2016, and TR2020
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: KXA
Date Received: 12/08/2016
Decision Date: 01/12/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Physical Medicine
Total pages: 1,124
Fully redacted pages: 954
Content pages: 170
Couldn't load pickup availability
PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.
View full details