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FDA 510(k)

MODEL RF-TENS-4 TRANSCUTANEOUS ELEC. NERVE STIMULA

K-Number: K853885 · 1986-01-30

ApplicantUniking Intl. Corp.
Decision Date1986-01-30
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODEL RF-TENS-4 TRANSCUTANEOUS ELEC. NERVE STIMULA is the device name listed in this FDA 510(k) record. The listed applicant is Uniking Intl. Corp.. It received FDA 510(k) clearance on 1986-01-30 under 510(k) number K853885. 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 MODEL RF-TENS-4 TRANSCUTANEOUS ELEC. NERVE STIMULA?

MODEL RF-TENS-4 TRANSCUTANEOUS ELEC. NERVE STIMULA is a medical device that received FDA 510(k) clearance on 1986-01-30. The listed applicant is Uniking Intl. Corp.. The 510(k) number is K853885.

When did MODEL RF-TENS-4 TRANSCUTANEOUS ELEC. NERVE STIMULA receive FDA 510(k) clearance?

MODEL RF-TENS-4 TRANSCUTANEOUS ELEC. NERVE STIMULA received FDA 510(k) clearance on 1986-01-30, under 510(k) number K853885.

Who is the listed applicant for MODEL RF-TENS-4 TRANSCUTANEOUS ELEC. NERVE STIMULA?

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

What is the FDA product code for MODEL RF-TENS-4 TRANSCUTANEOUS ELEC. NERVE STIMULA?

The FDA product code for MODEL RF-TENS-4 TRANSCUTANEOUS ELEC. NERVE STIMULA 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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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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