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FDA 510(k)

SMARTSTEP SYSTEM

K-Number: K023161 · 2002-12-10

ApplicantAndante Medical Device, Ltd.
Decision Date2002-12-10
Product CodeIRN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SMARTSTEP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Andante Medical Device, Ltd.. It received FDA 510(k) clearance on 2002-12-10 under 510(k) number K023161. 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?

SMARTSTEP SYSTEM is a medical device that received FDA 510(k) clearance on 2002-12-10. The listed applicant is Andante Medical Device, Ltd.. The 510(k) number is K023161.

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

SMARTSTEP SYSTEM received FDA 510(k) clearance on 2002-12-10, under 510(k) number K023161.

Who is the listed applicant for SMARTSTEP SYSTEM?

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

What is the FDA product code for SMARTSTEP SYSTEM?

The FDA product code for SMARTSTEP 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.

K060150SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEMAndante Medical Devices , 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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