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FDA 510(k)

SANIDAD TENS-DUO MODE GP8016N

K-Number: K021430 · 2002-12-02

ApplicantRolor Electronics Corp.
Decision Date2002-12-02
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SANIDAD TENS-DUO MODE GP8016N is the device name listed in this FDA 510(k) record. The listed applicant is Rolor Electronics Corp.. It received FDA 510(k) clearance on 2002-12-02 under 510(k) number K021430. 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 SANIDAD TENS-DUO MODE GP8016N?

SANIDAD TENS-DUO MODE GP8016N is a medical device that received FDA 510(k) clearance on 2002-12-02. The listed applicant is Rolor Electronics Corp.. The 510(k) number is K021430.

When did SANIDAD TENS-DUO MODE GP8016N receive FDA 510(k) clearance?

SANIDAD TENS-DUO MODE GP8016N received FDA 510(k) clearance on 2002-12-02, under 510(k) number K021430.

Who is the listed applicant for SANIDAD TENS-DUO MODE GP8016N?

The FDA 510(k) record lists Rolor Electronics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SANIDAD TENS-DUO MODE GP8016N?

The FDA product code for SANIDAD TENS-DUO MODE GP8016N 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 Rolor Electronics Corp. 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.

K020130ROLOR POWERED MUSCLE STIMULATOR, MODEL GP-8016MK020464SANIDAD FAR-INFRARED MINI LAMP, MODEL FI-3646K020462SANIDAD THERMAL FAR-INFRARED WAVE LAMP, MODEL AP-2018

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

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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