510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Wisdom Technologies, Inc.

Hefei Anhui, CN

WISDOM TECHNOLOGIES, INC. appears in FDA device records in Hefei Anhui, CN. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 2 510(k) clearances for Wisdom Technologies, Inc. in 2024.

Clearances by year, as a table
510(k) clearance decisions for Wisdom Technologies, Inc., by decision year
YearClearances
20242
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K232928DeepContour (V1.0)QKBSubstantially Equivalent
K231273ArcherQA (V1.0)IYESubstantially Equivalent

Registered establishments

FDA registered establishments for Wisdom Technologies, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30311943983031194398WISDOM TECHNOLOGIES, INC.4th Floor, Building F2, Phase II, Innovation Industrial Park, Hefei Anhui 230088 CN2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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What MDM checks, and what it does not

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Data as of , FDA export datePage updated Source: openFDA, public domain