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FDA 510(k)

MES-TENS(TENS)

K-Number: K853416 · 1985-11-07

ApplicantOriental Medical Supplies, Inc.
Decision Date1985-11-07
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MES-TENS(TENS) is the device name listed in this FDA 510(k) record. The listed applicant is Oriental Medical Supplies, Inc.. It received FDA 510(k) clearance on 1985-11-07 under 510(k) number K853416. 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 MES-TENS(TENS)?

MES-TENS(TENS) is a medical device that received FDA 510(k) clearance on 1985-11-07. The listed applicant is Oriental Medical Supplies, Inc.. The 510(k) number is K853416.

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

MES-TENS(TENS) received FDA 510(k) clearance on 1985-11-07, under 510(k) number K853416.

Who is the listed applicant for MES-TENS(TENS)?

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

What is the FDA product code for MES-TENS(TENS)?

The FDA product code for MES-TENS(TENS) is GZJ.

Other records listing Oriental 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.

K893372LATEX EXAMINATION GLOVESK871666MODEL HP (OR MODEL 1001) TRANSCUTANEOUS STIMULATORK853442MODEL 804 (TENS)K852610HOT PACKK850566MARUKYR-BAN / HOT OR HEAT PACK

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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