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FDA 510(k)

POINTER F-3 TENS

K-Number: K904388 · 1991-06-04

ApplicantOms Medical Supplies, Inc.
Decision Date1991-06-04
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

POINTER F-3 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 1991-06-04 under 510(k) number K904388. 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 POINTER F-3 TENS?

POINTER F-3 TENS is a medical device that received FDA 510(k) clearance on 1991-06-04. The listed applicant is Oms Medical Supplies, Inc.. The 510(k) number is K904388.

When did POINTER F-3 TENS receive FDA 510(k) clearance?

POINTER F-3 TENS received FDA 510(k) clearance on 1991-06-04, under 510(k) number K904388.

Who is the listed applicant for POINTER F-3 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 POINTER F-3 TENS?

The FDA product code for POINTER F-3 TENS is GZJ.

Related Clinical Trials

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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 240ZK904332MSTIM-2000 EMSK894964K-2 TENS OR MED TENSK884210TX-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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