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FDA 510(k)

SAFE-STEP

K-Number: K931517 · 1995-03-10

ApplicantLenjoy Engineering, Inc.
Decision Date1995-03-10
Product CodeIRN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SAFE-STEP is the device name listed in this FDA 510(k) record. The listed applicant is Lenjoy Engineering, Inc.. It received FDA 510(k) clearance on 1995-03-10 under 510(k) number K931517. 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 SAFE-STEP?

SAFE-STEP is a medical device that received FDA 510(k) clearance on 1995-03-10. The listed applicant is Lenjoy Engineering, Inc.. The 510(k) number is K931517.

When did SAFE-STEP receive FDA 510(k) clearance?

SAFE-STEP received FDA 510(k) clearance on 1995-03-10, under 510(k) number K931517.

Who is the listed applicant for SAFE-STEP?

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

What is the FDA product code for SAFE-STEP?

The FDA product code for SAFE-STEP is IRN.

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.K960307INDEX SHOEOrthopedic Technology Research, Inc.K955034FORCEGUARDImpact Monitors, Inc.

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.

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