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FDA 510(k)

UNIVERSAL WRIST

K-Number: K940297 · 1995-02-06

ApplicantTurnkey Intergration USA, Inc.
Decision Date1995-02-06
Product CodeJWI
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

UNIVERSAL WRIST is the device name listed in this FDA 510(k) record. The listed applicant is Turnkey Intergration USA, Inc.. It received FDA 510(k) clearance on 1995-02-06 under 510(k) number K940297. The device is classified under product code JWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the UNIVERSAL WRIST?

UNIVERSAL WRIST is a medical device that received FDA 510(k) clearance on 1995-02-06. The listed applicant is Turnkey Intergration USA, Inc.. The 510(k) number is K940297.

When did UNIVERSAL WRIST receive FDA 510(k) clearance?

UNIVERSAL WRIST received FDA 510(k) clearance on 1995-02-06, under 510(k) number K940297.

Who is the listed applicant for UNIVERSAL WRIST?

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

What is the FDA product code for UNIVERSAL WRIST?

The FDA product code for UNIVERSAL WRIST is JWI.

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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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