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Scottcare Corporation

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
5
Inspections
5
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1315-2016Class IITeleSentry Battery, 3.7 Li-Ion Polymer Battery, CAUTION Do not expose to high temperature. Do not diFebruary 25, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K250259TeleRehab Aermos Cardiopulmonary RehabilitationJune 4, 2025
K142180TELESENSEDecember 12, 2014
K092947TELESENTRY, MODEL TS01February 26, 2010
K083382CHROMA, MODEL: RZ153CAugust 13, 2009
K081359GENESIS ECPMay 29, 2008