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FDA 510(k)

INDEX SHOE

K-Number: K960307 · 1996-06-27

ApplicantOrthopedic Technology Research, Inc.
Decision Date1996-06-27
Product CodeIRN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

INDEX SHOE is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Technology Research, Inc.. It received FDA 510(k) clearance on 1996-06-27 under 510(k) number K960307. 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 INDEX SHOE?

INDEX SHOE is a medical device that received FDA 510(k) clearance on 1996-06-27. The listed applicant is Orthopedic Technology Research, Inc.. The 510(k) number is K960307.

When did INDEX SHOE receive FDA 510(k) clearance?

INDEX SHOE received FDA 510(k) clearance on 1996-06-27, under 510(k) number K960307.

Who is the listed applicant for INDEX SHOE?

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

What is the FDA product code for INDEX SHOE?

The FDA product code for INDEX SHOE is IRN.

Related Clinical Trials

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.

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Other records listing Orthopedic Technology Research, 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.

K991313ACCUTRED SHOE

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.K023161SMARTSTEP SYSTEMAndante Medical Device, Ltd.K991313ACCUTRED SHOEOrthopedic Technology Research, Inc.K962591FOOT WEIGHT ALARMCleveland Medical Devices, 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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