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FDA 510(k)

INTERCEPT T.E.N.S. DEVICE

K-Number: K880492 · 1988-04-18

ApplicantMedical Design & Manufacturing Corp.
Decision Date1988-04-18
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

INTERCEPT T.E.N.S. DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Medical Design & Manufacturing Corp.. It received FDA 510(k) clearance on 1988-04-18 under 510(k) number K880492. 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 INTERCEPT T.E.N.S. DEVICE?

INTERCEPT T.E.N.S. DEVICE is a medical device that received FDA 510(k) clearance on 1988-04-18. The listed applicant is Medical Design & Manufacturing Corp.. The 510(k) number is K880492.

When did INTERCEPT T.E.N.S. DEVICE receive FDA 510(k) clearance?

INTERCEPT T.E.N.S. DEVICE received FDA 510(k) clearance on 1988-04-18, under 510(k) number K880492.

Who is the listed applicant for INTERCEPT T.E.N.S. DEVICE?

The FDA 510(k) record lists Medical Design & Manufacturing Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTERCEPT T.E.N.S. DEVICE?

The FDA product code for INTERCEPT T.E.N.S. DEVICE is GZJ.

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Other records listing Medical Design & Manufacturing Corp. 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.

K911911MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEMK914384MEDICAL DESIGNS REUSABLE CARBON RUBBER ELECTRODEK911366PROTECTOR DISPOSABLE TENS AND NMES ELECTRODEK902822MEDICAL DESIGNS, INC., SPECTRUM II TENS DEVICEK895604SOFT-EZ REUSABLE SELF-ADHERING PIGTAIL ELECTRODESK834138HYPO SUTURE

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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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