TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS)— 510(k) K874469

Substantially Equivalent

Axelgaard Mfg. Co., Ltd.

FDA 510(k) clearance K874469 for TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS), Substantially Equivalent on 1988-01-28. Applicant: Axelgaard Mfg. Co., Ltd.. Device class: 2.

Clearance details

Applicant
Axelgaard Mfg. Co., Ltd.
Product code
Code GXY
Device class
Class 2
Regulation
21 CFR 882.1320
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Fallbrook, CA, US
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