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FDA 510(k)

PROGEL (TM) DUAL ELECTRODE PAD, MODEL 8535

K-Number: K882886 · 1988-09-29

ApplicantMedical Devices, Inc.
Decision Date1988-09-29
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PROGEL (TM) DUAL ELECTRODE PAD, MODEL 8535 is the device name listed in this FDA 510(k) record. The listed applicant is Medical Devices, Inc.. It received FDA 510(k) clearance on 1988-09-29 under 510(k) number K882886. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROGEL (TM) DUAL ELECTRODE PAD, MODEL 8535?

PROGEL (TM) DUAL ELECTRODE PAD, MODEL 8535 is a medical device that received FDA 510(k) clearance on 1988-09-29. The listed applicant is Medical Devices, Inc.. The 510(k) number is K882886.

When did PROGEL (TM) DUAL ELECTRODE PAD, MODEL 8535 receive FDA 510(k) clearance?

PROGEL (TM) DUAL ELECTRODE PAD, MODEL 8535 received FDA 510(k) clearance on 1988-09-29, under 510(k) number K882886.

Who is the listed applicant for PROGEL (TM) DUAL ELECTRODE PAD, MODEL 8535?

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

What is the FDA product code for PROGEL (TM) DUAL ELECTRODE PAD, MODEL 8535?

The FDA product code for PROGEL (TM) DUAL ELECTRODE PAD, MODEL 8535 is GXY.

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Other records listing Medical Devices, 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.

K002280PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602K930084MICRO-ARTHROSCOPEK943126ELECTROFLEXK940012SMARTBRACE ELECTRODEK935132HOME MICROCURRENT HMCK934619FLEXMATE

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Related Devices (Code: GXY)

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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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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