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FDA 510(k)

EMPI MODEL 989, TENS

K-Number: K881114 · 1988-04-15

ApplicantEmpi
Decision Date1988-04-15
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EMPI MODEL 989, TENS is the device name listed in this FDA 510(k) record. The listed applicant is Empi. It received FDA 510(k) clearance on 1988-04-15 under 510(k) number K881114. 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 EMPI MODEL 989, TENS?

EMPI MODEL 989, TENS is a medical device that received FDA 510(k) clearance on 1988-04-15. The listed applicant is Empi. The 510(k) number is K881114.

When did EMPI MODEL 989, TENS receive FDA 510(k) clearance?

EMPI MODEL 989, TENS received FDA 510(k) clearance on 1988-04-15, under 510(k) number K881114.

Who is the listed applicant for EMPI MODEL 989, TENS?

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

What is the FDA product code for EMPI MODEL 989, TENS?

The FDA product code for EMPI MODEL 989, TENS is GZJ.

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Other records listing Empi 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.

K093324EMPI CONTINUUMK090922EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATORK072946HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEMK070427DUPEL TRANSPORT IONTOPHORESIS SYSTEMK061650SELECT TENS, MODEL 4600SK041920INFINITY PLUS ELECTROTHERAPY SYSTEM

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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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