ULTRA IV— 510(k) K960489

Name: FDA 510(k) clearance K960489
Creator: U.S. Food and Drug Administration
Published: 1996-03-27

Substantially Equivalent for Some Indications

Excel Tech. , Ltd.

FDA 510(k) clearance K960489 for ULTRA IV, Substantially Equivalent for Some Indications on 1996-03-27. Applicant: Excel Tech. , Ltd.. Device class: 2.

Clearance details

Applicant: Excel Tech. , Ltd.
Product code: Code IPF
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 1996-02-02
Decision date: 1996-03-27
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Oakville,Ontario, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code IPF

view all

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 Excel Tech. , Ltd.

view all

K062549 — XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 1052382006-10-04
K061269 — XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES2006-08-14
K053386 — XLTEK EMU40 EEG HEADBOX, MODEL PK10722006-04-21
K053058 — XLTEK NEUROPATH, MODEL PK10702006-02-07
K052112 — XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK10592005-10-28

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