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FDA 510(k)

DIGIT WIDGET

K-Number: K992970 · 1999-11-08

ApplicantHand Biomechanics Lab, Inc.
Decision Date1999-11-08
Product CodeJDW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DIGIT WIDGET is the device name listed in this FDA 510(k) record. The listed applicant is Hand Biomechanics Lab, Inc.. It received FDA 510(k) clearance on 1999-11-08 under 510(k) number K992970. The device is classified under product code JDW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGIT WIDGET?

DIGIT WIDGET is a medical device that received FDA 510(k) clearance on 1999-11-08. The listed applicant is Hand Biomechanics Lab, Inc.. The 510(k) number is K992970.

When did DIGIT WIDGET receive FDA 510(k) clearance?

DIGIT WIDGET received FDA 510(k) clearance on 1999-11-08, under 510(k) number K992970.

Who is the listed applicant for DIGIT WIDGET?

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

What is the FDA product code for DIGIT WIDGET?

The FDA product code for DIGIT WIDGET is JDW.

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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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