Digitimer , Ltd.

FDA Regulatory Profile

Digitimer , Ltd. has 0 FDA recalls, 2 inspections, 2 510(k) clearances and 1 compliance action on record.

Latest inspection
Jul 2, 2015 · NAI
Latest 510(k)
Mar 6, 2018

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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) clearances2Oct 4, 2026Not statedCurrent
Inspections2Oct 26, 2026Not statedCurrent
Compliance actions1Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 2, 2015Welwyn Garden City, United KingdomDevicesNo Action Indicated (NAI)3003631667
Aug 30, 2012Welwyn Garden City, United KingdomDevicesVoluntary Action Indicated (VAI)3003631667

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
K172381Digitimer DS7AP Constant Current StimulatorMar 6, 2018
K051357DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A; DS7AH CONSTANT CURRENT HIGH VOLTAGE…Sep 20, 2005