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FDA 510(k)

PREMIER 10S (TENS)

K-Number: K881424 · 1988-04-11

ApplicantAmerican Imex
Decision Date1988-04-11
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PREMIER 10S (TENS) is the device name listed in this FDA 510(k) record. The listed applicant is American Imex. It received FDA 510(k) clearance on 1988-04-11 under 510(k) number K881424. 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 PREMIER 10S (TENS)?

PREMIER 10S (TENS) is a medical device that received FDA 510(k) clearance on 1988-04-11. The listed applicant is American Imex. The 510(k) number is K881424.

When did PREMIER 10S (TENS) receive FDA 510(k) clearance?

PREMIER 10S (TENS) received FDA 510(k) clearance on 1988-04-11, under 510(k) number K881424.

Who is the listed applicant for PREMIER 10S (TENS)?

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

What is the FDA product code for PREMIER 10S (TENS)?

The FDA product code for PREMIER 10S (TENS) 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 American Imex 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.

K032003PREMIER PLUSK982221PREMIER APK926326MICROCARE(TM)K912289ULTIMA XS, MODIFICATIONK895295ULTIMA XS MICROCURRENT TENSK894388ZIMMER TENS

View all 11 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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