Human Design Medical Llc

FDA Regulatory Profile

Human Design Medical Llc appears in FDA public data with 1 recall, 1 510(k) clearance, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2530-2018, Class III) was initiated on May 8, 2018. Its most recent 510(k) clearance was granted on October 17, 2014.

Summary

Total Recalls
1
510(k) Clearances
1
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2530-2018Class IIIVivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide continuous oMay 8, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K140929Z1 CPAP SYSTEMOctober 17, 2014