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FDA 510(k)

MODEL 804 (TENS)

K-Number: K853442 · 1985-12-09

ApplicantOriental Medical Supplies, Inc.
Decision Date1985-12-09
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODEL 804 (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 1985-12-09 under 510(k) number K853442. 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 MODEL 804 (TENS)?

MODEL 804 (TENS) is a medical device that received FDA 510(k) clearance on 1985-12-09. The listed applicant is Oriental Medical Supplies, Inc.. The 510(k) number is K853442.

When did MODEL 804 (TENS) receive FDA 510(k) clearance?

MODEL 804 (TENS) received FDA 510(k) clearance on 1985-12-09, under 510(k) number K853442.

Who is the listed applicant for MODEL 804 (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 MODEL 804 (TENS)?

The FDA product code for MODEL 804 (TENS) is GZJ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 STIMULATORK853416MES-TENS(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

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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