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FDA 510(k)

TENSMED II

K-Number: K851063 · 1985-06-04

ApplicantIntermedics, Inc.
Decision Date1985-06-04
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TENSMED II is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics, Inc.. It received FDA 510(k) clearance on 1985-06-04 under 510(k) number K851063. 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 TENSMED II?

TENSMED II is a medical device that received FDA 510(k) clearance on 1985-06-04. The listed applicant is Intermedics, Inc.. The 510(k) number is K851063.

When did TENSMED II receive FDA 510(k) clearance?

TENSMED II received FDA 510(k) clearance on 1985-06-04, under 510(k) number K851063.

Who is the listed applicant for TENSMED II?

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

What is the FDA product code for TENSMED II?

The FDA product code for TENSMED II is GZJ.

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Other records listing Intermedics, 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.

K954610MODEL 430-07 ENDOCARDIAL PACING LEADK955122INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADK962174BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)K955550CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEADK960281IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORYK954719INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD

View all 211 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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