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FDA 510(k)

TENS MODEL 8201

K-Number: K820496 · 1982-03-15

ApplicantMedical Scientific Instruments
Decision Date1982-03-15
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TENS MODEL 8201 is the device name listed in this FDA 510(k) record. The listed applicant is Medical Scientific Instruments. It received FDA 510(k) clearance on 1982-03-15 under 510(k) number K820496. 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 TENS MODEL 8201?

TENS MODEL 8201 is a medical device that received FDA 510(k) clearance on 1982-03-15. The listed applicant is Medical Scientific Instruments. The 510(k) number is K820496.

When did TENS MODEL 8201 receive FDA 510(k) clearance?

TENS MODEL 8201 received FDA 510(k) clearance on 1982-03-15, under 510(k) number K820496.

Who is the listed applicant for TENS MODEL 8201?

The FDA 510(k) record lists Medical Scientific Instruments as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TENS MODEL 8201?

The FDA product code for TENS MODEL 8201 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.

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Other records listing Medical Scientific Instruments 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.

K840821TRNS MI 8202

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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