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FDA 510(k)

SOFT-TOUCH TENS ELECTRODE

K-Number: K030375 · 2003-05-05

ApplicantPain Management Technologies
Decision Date2003-05-05
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SOFT-TOUCH TENS ELECTRODE 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 2003-05-05 under 510(k) number K030375. 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 SOFT-TOUCH TENS ELECTRODE?

SOFT-TOUCH TENS ELECTRODE is a medical device that received FDA 510(k) clearance on 2003-05-05. The listed applicant is Pain Management Technologies. The 510(k) number is K030375.

When did SOFT-TOUCH TENS ELECTRODE receive FDA 510(k) clearance?

SOFT-TOUCH TENS ELECTRODE received FDA 510(k) clearance on 2003-05-05, under 510(k) number K030375.

Who is the listed applicant for SOFT-TOUCH TENS ELECTRODE?

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 SOFT-TOUCH TENS ELECTRODE?

The FDA product code for SOFT-TOUCH TENS ELECTRODE 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 1000K011411SELF-ADHESIVE ELECTRODES

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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