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FDA 510(k)

GUARDIAN DISPOSABLE TENS AND TENS/NMES ELECTRODES

K-Number: K945676 · 1995-01-30

ApplicantSelectivemed Components, Inc.
Decision Date1995-01-30
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GUARDIAN DISPOSABLE TENS AND TENS/NMES ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Selectivemed Components, Inc.. It received FDA 510(k) clearance on 1995-01-30 under 510(k) number K945676. 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 GUARDIAN DISPOSABLE TENS AND TENS/NMES ELECTRODES?

GUARDIAN DISPOSABLE TENS AND TENS/NMES ELECTRODES is a medical device that received FDA 510(k) clearance on 1995-01-30. The listed applicant is Selectivemed Components, Inc.. The 510(k) number is K945676.

When did GUARDIAN DISPOSABLE TENS AND TENS/NMES ELECTRODES receive FDA 510(k) clearance?

GUARDIAN DISPOSABLE TENS AND TENS/NMES ELECTRODES received FDA 510(k) clearance on 1995-01-30, under 510(k) number K945676.

Who is the listed applicant for GUARDIAN DISPOSABLE TENS AND TENS/NMES ELECTRODES?

The FDA 510(k) record lists Selectivemed Components, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GUARDIAN DISPOSABLE TENS AND TENS/NMES ELECTRODES?

The FDA product code for GUARDIAN DISPOSABLE TENS AND TENS/NMES ELECTRODES is GZJ.

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Other records listing Selectivemed Components, Inc. 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.

K120922GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNITK083756GUARDIAN 150 ELECTRODEK031053SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7K020476MEDION 6000K993081IO-DRIVEK946230ENDURA REUSABLE TENS AND NMES ELECTRODES

View all 7 devices →

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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