Position Health, LLC

FDA Regulatory Profile

Position Health, LLC appears in FDA public data with 0 recalls, 1 510(k) clearance, 2 FDA inspections, and 0 compliance actions on record. Its most recent FDA inspection ended on Jun 3, 2021 (No Action Indicated (NAI)). Its most recent 510(k) clearance was granted on Jun 21, 2024.

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Summary

Total Recalls
0
510(k) Clearances
1
Inspections
2
Compliance Actions
0

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 3, 2021Lake Bluff, ILDevicesNo Action Indicated (NAI)3003473196
May 17, 2017Lake Bluff, ILDevicesNo Action Indicated (NAI)3003473196

FDA Data Dashboard classifications: NAI (no action indicated), VAI (voluntary action indicated), OAI (official action indicated).

Recent 510(k) Clearances

K-NumberDeviceDate
K233096PRESSUREALERT® Pressure Monitoring SystemJun 21, 2024