SDS-4I— 510(k) K034005

Substantially Equivalent

Skylark Device & Systems Co., Ltd.

FDA 510(k) clearance K034005 for SDS-4I, Substantially Equivalent on 2004-11-18. Applicant: Skylark Device & Systems Co., Ltd.. Device class: 2.

Clearance details

Applicant: Skylark Device & Systems Co., Ltd.
Product code: Code IPF
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2003-12-24
Decision date: 2004-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

Download summary PDF View on FDA.gov ↗

Recent devices under product code IPF

K253542 — Apollo Quattro (APQ-10M)2026-06-08
K252816 — High Tone Power therapy (HiToP) (Model: HiToP PNP)2026-06-02
K260142 — StimelMD (SSMD) system2026-05-27
K251083 — Compact II2025-09-12
K241433 — EVE Synergy (EVE-20M)2025-06-04

More clearances from Skylark Device & Systems Co., Ltd.

K053007 — SKYLARK URO PROBE2005-12-05
K050174 — BIO-STIM KIT2005-09-07
K043306 — SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IR2005-06-06
K002832 — CONDUCTIVE GEL FOR ULTRASOUND2001-08-06
K992652 — SD-730 IF-SDS, PERFECT PULSE IF-SDS2000-02-03

Data sourced from openFDA. This site is unofficial and independent of the FDA.