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FDA 510(k)

ACUPLUS

K-Number: K954334 · 1996-01-22

ApplicantS.H.P. Intl. Pty., Ltd.
Decision Date1996-01-22
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ACUPLUS is the device name listed in this FDA 510(k) record. The listed applicant is S.H.P. Intl. Pty., Ltd.. It received FDA 510(k) clearance on 1996-01-22 under 510(k) number K954334. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUPLUS?

ACUPLUS is a medical device that received FDA 510(k) clearance on 1996-01-22. The listed applicant is S.H.P. Intl. Pty., Ltd.. The 510(k) number is K954334.

When did ACUPLUS receive FDA 510(k) clearance?

ACUPLUS received FDA 510(k) clearance on 1996-01-22, under 510(k) number K954334.

Who is the listed applicant for ACUPLUS?

The FDA 510(k) record lists S.H.P. Intl. Pty., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACUPLUS?

The FDA product code for ACUPLUS is GZJ.

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 S.H.P. Intl. Pty., 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.

K014273ACUSTIM

Related Devices (Code: GZJ)

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.

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimedK252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLCK232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical OfficerK233046Electrical Neuromuscular Stimulator, Cure TrioOriental Inspiration Limited

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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