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

FDA 510(k)

CyMedica e-vive™ System; CY-1000

K-Number: K163067 · 2016-12-01

ApplicantCymedica Orthopedics, Inc.
Decision Date2016-12-01
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

CyMedica e-vive™ System; CY-1000 is the device name listed in this FDA 510(k) record. The listed applicant is Cymedica Orthopedics, Inc.. It received FDA 510(k) clearance on 2016-12-01 under 510(k) number K163067. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CyMedica e-vive™ System; CY-1000?

CyMedica e-vive™ System; CY-1000 is a medical device that received FDA 510(k) clearance on 2016-12-01. The listed applicant is Cymedica Orthopedics, Inc.. The 510(k) number is K163067.

When did CyMedica e-vive™ System; CY-1000 receive FDA 510(k) clearance?

CyMedica e-vive™ System; CY-1000 received FDA 510(k) clearance on 2016-12-01, under 510(k) number K163067.

Who is the listed applicant for CyMedica e-vive™ System; CY-1000?

The FDA 510(k) record lists Cymedica Orthopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CyMedica e-vive™ System; CY-1000?

The FDA product code for CyMedica e-vive™ System; CY-1000 is IPF.

Other records listing Cymedica Orthopedics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230533Motive™ ElectrodeK220738Motive Knee WrapK210604Intellihab System

Related Devices (Code: IPF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali NezakatiK260142StimelMD (SSMD) systemMotion Informatics ltd.K251083Compact IIEnraf-Nonius, B.V.K241433EVE Synergy (EVE-20M)Weero Co., Ltd.K241488TrainFES AdvanceTrainfes

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.

↑