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FDA 510(k)

TX-4(TENS) (SIGMA TENS)

K-Number: K874550 · 1987-11-20

ApplicantOms Medico, Inc.
Decision Date1987-11-20
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TX-4(TENS) (SIGMA TENS) is the device name listed in this FDA 510(k) record. The listed applicant is Oms Medico, Inc.. It received FDA 510(k) clearance on 1987-11-20 under 510(k) number K874550. 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 TX-4(TENS) (SIGMA TENS)?

TX-4(TENS) (SIGMA TENS) is a medical device that received FDA 510(k) clearance on 1987-11-20. The listed applicant is Oms Medico, Inc.. The 510(k) number is K874550.

When did TX-4(TENS) (SIGMA TENS) receive FDA 510(k) clearance?

TX-4(TENS) (SIGMA TENS) received FDA 510(k) clearance on 1987-11-20, under 510(k) number K874550.

Who is the listed applicant for TX-4(TENS) (SIGMA TENS)?

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

What is the FDA product code for TX-4(TENS) (SIGMA TENS)?

The FDA product code for TX-4(TENS) (SIGMA TENS) is GZJ.

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Other records listing Oms Medico, 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.

K874333TX-2(TENS)K873420GLOBALCARE(TENS)K873484120Z(TENS)K871699TX-3(TENS)K865063UNI-PULS(TENS) MODEL #292K870583NEU-PULS(TENS) MODEL #295

View all 7 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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