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

Edinburgh Edinburgh, City of, GB

Current Health Inc appears in FDA device records in Edinburgh Edinburgh, City of, GB. FDA records list 5 510(k) clearances between and , no PMA records and 2 registered establishments. 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
5
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 5 510(k) clearances for Current Health Inc between 2019 and 2023. The busiest year on record is 2019, with 2. The most recent is 2023, with 1.

Clearances by year, as a table
510(k) clearance decisions for Current Health Inc, by decision year
YearClearances
20192
20211
20221
20231
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K231506Current Health SystemMSXSubstantially Equivalent
K222550Current Health SystemMSXSubstantially Equivalent
K210133Current Health Monitoring System Gen 2 (G2)MSXSubstantially Equivalent
K191272Wearable Device, Wearable PackageMSXSubstantially Equivalent
K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without HomehubMSXSubstantially Equivalent

Registered establishments

FDA registered establishments for Current Health Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30447543363044754336Current Health Inc2400 Mount Read Blvd Dock 55 Building 205, Rochester, NY 14615 US2026
30151340043015134004Current Health LtdThe Stamp Office, Level 3, Edinburgh Edinburgh, City of EH1 3EG GB2026

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

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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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