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FDA 510(k)

TENS-O-MATIC

K-Number: K811012 · 1981-06-01

ApplicantO-Matic, Inc.
Decision Date1981-06-01
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TENS-O-MATIC is the device name listed in this FDA 510(k) record. The listed applicant is O-Matic, Inc.. It received FDA 510(k) clearance on 1981-06-01 under 510(k) number K811012. 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 TENS-O-MATIC?

TENS-O-MATIC is a medical device that received FDA 510(k) clearance on 1981-06-01. The listed applicant is O-Matic, Inc.. The 510(k) number is K811012.

When did TENS-O-MATIC receive FDA 510(k) clearance?

TENS-O-MATIC received FDA 510(k) clearance on 1981-06-01, under 510(k) number K811012.

Who is the listed applicant for TENS-O-MATIC?

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

What is the FDA product code for TENS-O-MATIC?

The FDA product code for TENS-O-MATIC is GZJ.

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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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