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FDA 510(k)

SELF-ADHESIVE ELECTRODES

K-Number: K011411 · 2001-06-13

ApplicantPain Management Technologies
Decision Date2001-06-13
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SELF-ADHESIVE ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Pain Management Technologies. It received FDA 510(k) clearance on 2001-06-13 under 510(k) number K011411. 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 SELF-ADHESIVE ELECTRODES?

SELF-ADHESIVE ELECTRODES is a medical device that received FDA 510(k) clearance on 2001-06-13. The listed applicant is Pain Management Technologies. The 510(k) number is K011411.

When did SELF-ADHESIVE ELECTRODES receive FDA 510(k) clearance?

SELF-ADHESIVE ELECTRODES received FDA 510(k) clearance on 2001-06-13, under 510(k) number K011411.

Who is the listed applicant for SELF-ADHESIVE ELECTRODES?

The FDA 510(k) record lists Pain Management Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SELF-ADHESIVE ELECTRODES?

The FDA product code for SELF-ADHESIVE ELECTRODES is GXY.

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 Pain Management Technologies 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.

K120054ULTIMA NEOK083494ULTIMA FIVEK073386JOINT STIM, MODEL 1000K030375SOFT-TOUCH TENS ELECTRODE

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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