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FDA 510(k)

T.E.N.S. UNIT SIGMA & TX-3

K-Number: K883188 · 1988-12-16

ApplicantDiamond Medical Equipment, Inc.
Decision Date1988-12-16
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

T.E.N.S. UNIT SIGMA & TX-3 is the device name listed in this FDA 510(k) record. The listed applicant is Diamond Medical Equipment, Inc.. It received FDA 510(k) clearance on 1988-12-16 under 510(k) number K883188. 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 T.E.N.S. UNIT SIGMA & TX-3?

T.E.N.S. UNIT SIGMA & TX-3 is a medical device that received FDA 510(k) clearance on 1988-12-16. The listed applicant is Diamond Medical Equipment, Inc.. The 510(k) number is K883188.

When did T.E.N.S. UNIT SIGMA & TX-3 receive FDA 510(k) clearance?

T.E.N.S. UNIT SIGMA & TX-3 received FDA 510(k) clearance on 1988-12-16, under 510(k) number K883188.

Who is the listed applicant for T.E.N.S. UNIT SIGMA & TX-3?

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

What is the FDA product code for T.E.N.S. UNIT SIGMA & TX-3?

The FDA product code for T.E.N.S. UNIT SIGMA & TX-3 is GZJ.

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Other records listing Diamond Medical Equipment, 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.

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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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