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Quickie Pulse - 6BC

FDA 510(k)

Class II (US FDA 510(k))

510(k) K160031

by Sunrise Medical (US) LLC

Identifiers

510(k) Number
K160031 FDA 510(k)
FDA Product Code
ITI FDA 510(k)
Models / Variants
6BC FDA 510(k)
6SC FDA 510(k)
6CC FDA 510(k)
5BC FDA 510(k)
5CC FDA 510(k)
6MPC) FDA 510(k)
Zippie ZM-310 (Models BC FDA 510(k)
SC) FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 890.3860 FDA 510(k)
Regulation Number
890.3860 FDA 510(k)
Advisory Committee
Physical Medicine FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Quickie Pulse - 6BC by Sunrise Medical (US) LLC — Class II — FDA_510K — listed in FDA 510(k) — 8 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sunrise Medical (US) LLC
FDA Applicant
Sunrise Medical (Us), LLC

Sources (1)

  • FDA 510(k) K160031 24 fields · synced Jun 19, 2026