Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Propeller Sensor Model 2015-E

K-Number: K161454 · 2016-11-01

ApplicantReciprocal Labs Corporation
Decision Date2016-11-01
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Propeller Sensor Model 2015-E is a medical device manufactured by Reciprocal Labs Corporation. It received FDA 510(k) clearance on 2016-11-01 under approval number K161454. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Propeller Sensor Model 2015-E?

Propeller Sensor Model 2015-E is a medical device that received FDA 510(k) clearance on 2016-11-01. It is manufactured by Reciprocal Labs Corporation. The 510(k) number is K161454.

When was Propeller Sensor Model 2015-E approved by the FDA?

Propeller Sensor Model 2015-E received FDA 510(k) clearance on 2016-11-01, under approval number K161454.

What company makes Propeller Sensor Model 2015-E?

Propeller Sensor Model 2015-E is manufactured by Reciprocal Labs Corporation.

What is the FDA product code for Propeller Sensor Model 2015-E?

The FDA product code for Propeller Sensor Model 2015-E is CAF.

Related Clinical Trials

NCT07232667 Digital Technology for Active and Healthy Ageing in Taiwan RECRUITING

Related PubMed Literature

PMID: 40006408 Improving Fall Classification Accuracy of Multi-Input Models Using Three-Axis Accelerometer and Heart Rate Variability Data. Sensors (Basel, Switzerland) (2025)

Other Devices by Reciprocal Labs Corporation

K180770Propeller Sensor for Neohaler K192724Propeller Sensor for Symbicort

Related Devices (Code: CAF)

K153010Hudson RCI AquaPak Sterile Prefilled NebulizersTeleflexmedical, Inc. K152882Propeller SystemReciprocal Labs K152482Propeller Sensor Model 2014-RReciprocal Labs K142541POCKET NEBMicrovaper Devices K170916Portable NebulizerMicrobase Technology Corporation K170853InnoSpire GoRespironics Respiratory Drug Delivery (Uk) , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑