GB-1002 TENS WITH MASSAGE— 510(k) K964437

Name: FDA 510(k) clearance K964437
Creator: U.S. Food and Drug Administration
Published: 1998-08-14

Substantially Equivalent

Skylark Device Co., Ltd.

FDA 510(k) clearance K964437 for GB-1002 TENS WITH MASSAGE, Substantially Equivalent on 1998-08-14. Applicant: Skylark Device Co., Ltd.. Device class: 2.

Clearance details

Applicant: Skylark Device Co., Ltd.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1996-11-05
Decision date: 1998-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

Download summary PDF View on FDA.gov ↗

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