DeviceClearance

TAMTEC-HANA TENS / EMS (Sport Muscle Stimulator)— 510(k) K143059

Substantially Equivalent

Tone-A-Matic International, Inc.

FDA 510(k) clearance K143059 for TAMTEC-HANA TENS / EMS (Sport Muscle Stimulator), Substantially Equivalent on 2015-01-26. Applicant: Tone-A-Matic International, Inc.. Device class: 2.

Clearance details

Applicant
Tone-A-Matic International, Inc.
Product code
Code NGX
Device class
Class 2
Regulation
21 CFR 890.5850
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mississauga, CA
Download summary PDFView on FDA.gov ↗

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