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FDA 510(k)

PRE-PACK TENS

K-Number: K813286 · 1982-01-22

ApplicantCunningham Woodland, Inc.
Decision Date1982-01-22
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PRE-PACK TENS is the device name listed in this FDA 510(k) record. The listed applicant is Cunningham Woodland, Inc.. It received FDA 510(k) clearance on 1982-01-22 under 510(k) number K813286. The device is classified under product code GDY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRE-PACK TENS?

PRE-PACK TENS is a medical device that received FDA 510(k) clearance on 1982-01-22. The listed applicant is Cunningham Woodland, Inc.. The 510(k) number is K813286.

When did PRE-PACK TENS receive FDA 510(k) clearance?

PRE-PACK TENS received FDA 510(k) clearance on 1982-01-22, under 510(k) number K813286.

Who is the listed applicant for PRE-PACK TENS?

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

What is the FDA product code for PRE-PACK TENS?

The FDA product code for PRE-PACK TENS is GDY.

Other records listing Cunningham Woodland, 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.

K823527SUBCLAVIAN INSERTION KITK813519NON-ABSORBENT TOWELSK813284VENOUS CANNULA TRAYK811088DRESSING TRAY MERCY HOSPITALK811090MAJOR DRESSING TRAYK811089ONE STEP PREP KIT

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Related Devices (Code: GDY)

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.

K972634ULTRACELL SUCTION SPONGEUltracell Medical Technologies, Inc.K960236CPR LAP SPONGESCustom Pack ReliabilityK955599STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGEStryker Corp.K955322PROTEC X-RAY DETECTABLE GAUZE SPONGEDerivados DE Gasa, S.A. DE C.V.K953830KENSORBKentron Health Care, Inc.K953059KITTNER DISSECTORMedical Perspectives Corp.

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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