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TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS)

K874469 Class II Traditional
Decision Date
1988-01-28
Sponsor / Applicant
Axelgaard Mfg. Co., Ltd.

Technical Specification

510(k) Submission ID K874469
Product Code GXY
Medical Specialty / Panel Neurology
Regulation Citation 21 CFR 882.1320
Decision Date 1988-01-28
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS) received FDA 510(k) clearance under submission number K874469, sponsored by Axelgaard Mfg. Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1988-01-28.

Classification & Regulation

This clearance is catalogued under FDA product code GXY and 21 CFR 882.1320, within the Neurology review panel as a Class II device.