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FDA 510(k)

SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM

K-Number: K060150 · 2006-02-23

ApplicantAndante Medical Devices , Ltd.
Decision Date2006-02-23
Product CodeIRN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Andante Medical Devices , Ltd.. It received FDA 510(k) clearance on 2006-02-23 under 510(k) number K060150. The device is classified under product code IRN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM?

SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM is a medical device that received FDA 510(k) clearance on 2006-02-23. The listed applicant is Andante Medical Devices , Ltd.. The 510(k) number is K060150.

When did SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM receive FDA 510(k) clearance?

SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM received FDA 510(k) clearance on 2006-02-23, under 510(k) number K060150.

Who is the listed applicant for SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM?

The FDA 510(k) record lists Andante Medical Devices , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM?

The FDA product code for SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM is IRN.

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Related Devices (Code: IRN)

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.

K023161SMARTSTEP SYSTEMAndante Medical Device, Ltd.K991313ACCUTRED SHOEOrthopedic Technology Research, Inc.K962591FOOT WEIGHT ALARMCleveland Medical Devices, Inc.K960307INDEX SHOEOrthopedic Technology Research, Inc.K955034FORCEGUARDImpact Monitors, Inc.K950656PED ALERTOrbitec Technologies Corp.

Official Source

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

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