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FDA 510(k)

HANDMASTER

K-Number: K010837 · 2001-06-15

ApplicantNeuromusclar Electrical Stimulation Systems, Ltd.
Decision Date2001-06-15
Product CodeGZI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HANDMASTER is the device name listed in this FDA 510(k) record. The listed applicant is Neuromusclar Electrical Stimulation Systems, Ltd.. It received FDA 510(k) clearance on 2001-06-15 under 510(k) number K010837. The device is classified under product code GZI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HANDMASTER?

HANDMASTER is a medical device that received FDA 510(k) clearance on 2001-06-15. The listed applicant is Neuromusclar Electrical Stimulation Systems, Ltd.. The 510(k) number is K010837.

When did HANDMASTER receive FDA 510(k) clearance?

HANDMASTER received FDA 510(k) clearance on 2001-06-15, under 510(k) number K010837.

Who is the listed applicant for HANDMASTER?

The FDA 510(k) record lists Neuromusclar Electrical Stimulation Systems, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HANDMASTER?

The FDA product code for HANDMASTER is GZI.

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 Neuromusclar Electrical Stimulation Systems, Ltd. 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.

K952273HANDMASTER NMS1

Related Devices (Code: GZI)

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.

K242704Synchrony (20-3000)Synapse Biomedical, Inc.K243828CIONIC NEURAL SLEEVE (NS-200)Cionic, Inc.K240632Neuvotion NeuStim NN-01Neuvotion, Inc.K233006MyndMove, MyndMove 2.0Myndtec, Inc.K230997EvoWalk 1.0 SystemEvolution Devices, Inc.K221823Cionic Neural Sleeve NS-100Cionic

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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