FDA 510(k)

A-T TENS BELT

K-Number: K843793 · 1984-10-12

Decision Date1984-10-12

Product CodeGZJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

A-T TENS BELT is the device name listed in this FDA 510(k) record. The listed applicant is A-T Surgical Mfg. Co., Inc.. It received FDA 510(k) clearance on 1984-10-12 under 510(k) number K843793. 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 A-T TENS BELT?

A-T TENS BELT is a medical device that received FDA 510(k) clearance on 1984-10-12. The listed applicant is A-T Surgical Mfg. Co., Inc.. The 510(k) number is K843793.

When did A-T TENS BELT receive FDA 510(k) clearance?

A-T TENS BELT received FDA 510(k) clearance on 1984-10-12, under 510(k) number K843793.

Who is the listed applicant for A-T TENS BELT?

The FDA 510(k) record lists A-T Surgical Mfg. Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A-T TENS BELT?

The FDA product code for A-T TENS BELT is GZJ.

Other records listing A-T Surgical Mfg. Co., 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.

K871889COMPRESSION LEGGING DEVICE

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K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimed K252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC K232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical Officer K233046Electrical 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.