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FDA 510(k)

K-2 TENS OR MED TENS

K-Number: K894964 · 1990-01-04

ApplicantOms Medical Supplies, Inc.
Decision Date1990-01-04
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

K-2 TENS OR MED TENS is the device name listed in this FDA 510(k) record. The listed applicant is Oms Medical Supplies, Inc.. It received FDA 510(k) clearance on 1990-01-04 under 510(k) number K894964. 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 K-2 TENS OR MED TENS?

K-2 TENS OR MED TENS is a medical device that received FDA 510(k) clearance on 1990-01-04. The listed applicant is Oms Medical Supplies, Inc.. The 510(k) number is K894964.

When did K-2 TENS OR MED TENS receive FDA 510(k) clearance?

K-2 TENS OR MED TENS received FDA 510(k) clearance on 1990-01-04, under 510(k) number K894964.

Who is the listed applicant for K-2 TENS OR MED TENS?

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

What is the FDA product code for K-2 TENS OR MED TENS?

The FDA product code for K-2 TENS OR MED TENS is GZJ.

Other records listing Oms Medical Supplies, 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.

K963194ITO ACUPUNCTURE NEEDLESK920266TENS MODEL 240ZK904388POINTER F-3 TENSK904332MSTIM-2000 EMSK884210TX-7 (TENS) (IC-1107)

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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