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FAQ™ (FAQ 411) (K261565): 510(k) cleared for Foreo, Inc. vs Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143) (K261574): 510(k) cleared for Hong Qiangxing (Shenzhen) Electronics Limited: FDAPulse comparison

FAQ™ (FAQ 411) (K261565): 510(k) cleared for Foreo, Inc.'s review days of 164 is 1.0x Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143) (K261574): 510(k) cleared for Hong Qiangxing (Shenzhen) Electronics Limited's 157 (59th percentile). FAQ™ (FAQ 411) (K261565): 510(k) cleared for Foreo, Inc. is dated 2026-10-22; Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143) (K261574): 510(k) cleared for Hong Qiangxing (Shenzhen) Electronics Limited 2026-10-16.

Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

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How does FAQ™ (FAQ 411) (K261565): 510(k) cleared for Foreo, Inc. compare to Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143) (K261574): 510(k) cleared for Hong Qiangxing (Shenzhen) Electronics Limited?

FieldFAQ™ (FAQ 411) (K261565): 510(k) cleared for Foreo, Inc.Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143) (K261574): 510(k) cleared for Hong Qiangxing (Shenzhen) Electronics Limited
Record510(k) clearance510(k) clearance
510(k) numberK261565K261574
DeviceFAQ™ (FAQ 411)Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143)
ApplicantForeo, Inc.Hong Qiangxing (Shenzhen) Electronics Limited
Specialty / panelNeurologyNeurology
Product codeNFONUH
Device class22
Clearance typeTraditionalTraditional
DecisionSubstantially EquivalentSubstantially Equivalent
Received2026-05-112026-05-12
Decision date2026-10-222026-10-16
Review time (days)164157
Third-party reviewNoNo
Applicant locationLas Vegas, NV, USShenzhen, CN
amount percentile59th59th
Predicate Speed & CAPA Advisory Opportunity Score54/10048/100
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Official records: FAQ™ (FAQ 411) (K261565): 510(k) cleared for Foreo, Inc. · Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143) (K261574): 510(k) cleared for Hong Qiangxing (Shenzhen) Electronics Limited

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Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.

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