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Lifestyle Circulatory Enhancer

FDA 510(k)

Class II (US FDA 510(k))

510(k) K040084

by Advanced Circulatory Systems Inc

Identifiers

510(k) Number
K040084 FDA 510(k)
FDA Product Code
BWF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5690 FDA 510(k)
Regulation Number
868.5690 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Lifestyle Circulatory Enhancer by Advanced Circulatory Systems Inc — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

FDA Applicant
Advanced Circulatory Systems, Inc.

Sources (1)

  • FDA 510(k) K040084 24 fields · synced Jun 18, 2026