21St Century Scientific, Inc.

FDA Regulatory Profile

21St Century Scientific, Inc. has 0 FDA recalls, 5 inspections, 3 510(k) clearances and 1 compliance action on record.

Latest inspection
Sep 17, 2021 · NAI
Latest 510(k)
Sep 3, 2020

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances3Oct 4, 2026Not statedCurrent
Inspections5Oct 25, 2026Not statedCurrent
Compliance actions1Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Sep 17, 2021Coeur D Alene, IDDevicesNo Action Indicated (NAI)1000125727
Sep 12, 2018Coeur D Alene, IDDevicesOfficial Action Indicated (OAI)1000125727
Mar 21, 2017Coeur D Alene, IDDevicesVoluntary Action Indicated (VAI)1000125727
Jul 13, 2011Coeur D Alene, IDDevicesVoluntary Action Indicated (VAI)1000125727
Oct 29, 2008Coeur D Alene, IDDevicesVoluntary Action Indicated (VAI)1000125727

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K193599BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG…Sep 3, 2020
K954044SIDEKICK POWER WHEELCHAIROct 13, 1995
K901210BOUNDER VA POWER WHEELCHAIRMar 26, 1990