FDA 510(k) K000655, PPCID- PNEUMATIC PERIPHERAL CIRCULATION IMPROVEMENT (FOOTREST) DEVICE, by Ahava Stein

FDA 510(k) K000655, PPCID- PNEUMATIC PERIPHERAL CIRCULATION IMPROVEMENT (FOOTREST) DEVICE, by Ahava Stein

Regular price $419.04 USD
Regular price Sale price $419.04 USD
Sale Sold out

Device Classification Name: Massager, Powered Inflatable Tube
510(k) Number: K000655
Device Name: PPCID- PNEUMATIC PERIPHERAL CIRCULATION IMPROVEMENT (FOOTREST) DEVICE
Applicant: Ahava Stein
Regulation Number: 890.5650
Classification Product Code: IRP
Date Received: 02/28/2000
Decision Date: 03/26/2001
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Physical Medicine
510k Review Panel: Physical Medicine

Total number of pages: 296
Fully redacted pages: 177
Content pages: 119

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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