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FDA 510(k)

MODIFICATION TO HANDMASTER

K-Number: K012823 · 2001-11-14

ApplicantNess-Neuromuscular Electrical Stimulation Systems
Decision Date2001-11-14
Product CodeGZI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO HANDMASTER is the device name listed in this FDA 510(k) record. The listed applicant is Ness-Neuromuscular Electrical Stimulation Systems. It received FDA 510(k) clearance on 2001-11-14 under 510(k) number K012823. 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 MODIFICATION TO HANDMASTER?

MODIFICATION TO HANDMASTER is a medical device that received FDA 510(k) clearance on 2001-11-14. The listed applicant is Ness-Neuromuscular Electrical Stimulation Systems. The 510(k) number is K012823.

When did MODIFICATION TO HANDMASTER receive FDA 510(k) clearance?

MODIFICATION TO HANDMASTER received FDA 510(k) clearance on 2001-11-14, under 510(k) number K012823.

Who is the listed applicant for MODIFICATION TO HANDMASTER?

The FDA 510(k) record lists Ness-Neuromuscular Electrical Stimulation Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO HANDMASTER?

The FDA product code for MODIFICATION TO HANDMASTER is GZI.

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Other records listing Ness-Neuromuscular Electrical Stimulation Systems as applicant

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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

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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