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Merits Healthcare Industries (Suzhou) Co., Ltd.

FDA Regulatory Profile

Merits Healthcare Industries (Suzhou) Co., Ltd. has 0 FDA recalls, 2 inspections, 1 510(k) clearance and 0 compliance actions on record.

Latest inspection
Jun 5, 2025 · VAI
Latest 510(k)
Nov 16, 2017

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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) clearances1Oct 4, 2026Not statedCurrent
Inspections2Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 5, 2025Suzhou, ChinaDevicesVoluntary Action Indicated (VAI)3003327839
Feb 5, 2015Suzhou, ChinaDevicesVoluntary Action Indicated (VAI)3003327839

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
K170517Merits Model R106/R136 Rehab WheelchairNov 16, 2017

FDA data resources