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FDA 510(k)

WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS

K-Number: K030519 · 2003-06-10

ApplicantHand Biomechanics Lab, Inc.
Decision Date2003-06-10
Product CodeJEC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS 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 2003-06-10 under 510(k) number K030519. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS?

WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS is a medical device that received FDA 510(k) clearance on 2003-06-10. The listed applicant is Hand Biomechanics Lab, Inc.. The 510(k) number is K030519.

When did WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS receive FDA 510(k) clearance?

WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS received FDA 510(k) clearance on 2003-06-10, under 510(k) number K030519.

Who is the listed applicant for WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS?

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 WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS?

The FDA product code for WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS is JEC.

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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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