History

1992

Acute Ideas Co., Ltd. is established and had a small production in Taiwan.

1993

Paci-Temp Digital Pacifier Thermometer granted the "Good Product Design Award" in Taiwan.

1994

Have done the clinic research on Paci-Temp from May 1994 till January 1995 in USA.

1995

Receive FDA 510(K) approval on Paci-Temp and this is the 1st pacifier thermometer received 510(K) letter.

1997

Paci-Temp pacifier thermometer sales quantities burst 1.2 million+ within one year.

2001

A new concept pacifier "iClose Stay-Clean Winged Pacifier" granted the "Good Product Design Award“

2002

Taipei office is expanded and moved to "Taipei Neihu Technology Park" in August.

2005

The 3rd generation of "iClose" stay-clean pacifier granted the "Good Product Design Award“.

2008

"Ear/forehead 2-in-1 infrared thermometer" granted the "Good Product Design Award".

2009

"Ear/forehead 2-in-1 infrared thermometer" granted the "IF" Product Design Award.

2010

Included Breast Pump into product line and teamed up with Rumble Tuff brand in USA.

2012

Set up production factory in Huizhou, China.
Receive FDA 510(K) Pre-market notification on Electric Breast Pump.
Manual Breast Pumps-Sweet Assist granted the "Golden Design Award" in Taiwan.

2013

Electric breast pump starts to ship to USA, Malaysia and Turkey and contributed 10% on sales revenue.

2014

Electric breast pump starts to ship to Thailand and Poland.
Both Electric and Manual breast pump received Medical Device CE Certificate in August.

2015

Electric breast pump starts to ship to Denmark and France.

2016

Factory inspected by FDA on Jan. according QSIT and passed.

2019

Rumble Tuff hospital grade pump for multi-user has 510(K) approval.

Certificate

ISO 13485 2016

ISO 13485 2016

ISO 13485 2016-1

ISO 13485 2016-1

FDA 510(k) PA K113315

FDA 510(k) PA K113315

CE_MT&MP_Thermometer (NB2460)_Class IIa_valid 20240527_page_1

CE_MT&MP_Thermometer (NB2460)_Class IIa_valid 20240527_page_1

CE_MT&MP_Thermometer (NB2460)_Class IIa_valid 20240527_page_2

CE_MT&MP_Thermometer (NB2460)_Class IIa_valid 20240527_page_2

CE_MT&MP_Thermometer (NB2460)_Class IIa_valid 20240527_page_3

CE_MT&MP_Thermometer (NB2460)_Class IIa_valid 20240527_page_3

FDA 510(k) MT K023711_page_3

FDA 510(k) MT K023711_page_3

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