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FDA 510(k)

TENS-AID PREMIUM ELECTRODES

K-Number: K843964 · 1985-02-25

ApplicantStaodynamics, Inc.
Decision Date1985-02-25
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TENS-AID PREMIUM ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Staodynamics, Inc.. It received FDA 510(k) clearance on 1985-02-25 under 510(k) number K843964. 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 TENS-AID PREMIUM ELECTRODES?

TENS-AID PREMIUM ELECTRODES is a medical device that received FDA 510(k) clearance on 1985-02-25. The listed applicant is Staodynamics, Inc.. The 510(k) number is K843964.

When did TENS-AID PREMIUM ELECTRODES receive FDA 510(k) clearance?

TENS-AID PREMIUM ELECTRODES received FDA 510(k) clearance on 1985-02-25, under 510(k) number K843964.

Who is the listed applicant for TENS-AID PREMIUM ELECTRODES?

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

What is the FDA product code for TENS-AID PREMIUM ELECTRODES?

The FDA product code for TENS-AID PREMIUM ELECTRODES is GXY.

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Other records listing Staodynamics, 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.

K852298TENS-AID STERILE ELECTRODES FOR POST-OP TENSK832988STAODYN EMS/PLUSK81328310D (TENS DEVICE)K813098TENS DEVICEK811345INSIGHTK792501PLS MINI

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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

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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