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SOTERA WIRELESS

Last updated September 17, 2026

Information

Country: US
Address: 5841 Edison Place, Carlsbad, CA, 92008
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3009673645
DUNS Number: —

Catalogue (40)

Device	Model / Reference	Registries	Class	Status
ViSi	Disposable Wrist Cradle, Small (Qty 20)	FDA UDI	Class II	Active
ViSi	Mobile Monitor, Single Band, Refurbished	FDA UDI	Class II	Active
ViSi Mobile System Package	5-lead AAMI	FDA UDI	Class II	Active
ViSi	Cuff Module	FDA UDI	Class II	Active
ViSi	Disposable Adult Cuff, Medium+ (Qty 20)	FDA UDI	Class II	Active
ViSi	ViSi Mobile Charger, 8-Bay	FDA UDI	Class II	Active
ViSi	ViSi Mobile Cuff Module, Refurbished	FDA UDI	Class II	Active
ViSi	Mobile Monitor, Dual Band, Refurbished	FDA UDI	Class II	Active
ViSi	Chest Sensor Securements, 3M (Qty 100)	FDA UDI	Class II	Active
ViSi Mobile System Package	3-lead IEC	FDA UDI	Class II	Active
ViSi	Chest Sensor, 3 Lead, IEC, WH	FDA UDI	Class II	Active
ViSi	Chest Sensor, 5 Lead, IEC, WH	FDA UDI	Class II	Active
ViSi	Chest Sensor, 5 Lead, AAMI, WH	FDA UDI	Class II	Active
ViSi	Disposable Wrist Cradle, Medium (Qty 20)	FDA UDI	Class II	Active
ViSi	Disposable Adult Cuff, Small (Qty 20)	FDA UDI	Class II	Active
ViSi	NIBP Adapter	FDA UDI	Class II	Active
ViSi	Thumb Sensor	FDA UDI	Class II	Active
ViSi	Chest Sensor Securements (Qty 100)	FDA UDI	Class II	Active
ViSi	Disposable Adult Cuff, Medium (Qty 20)	FDA UDI	Class II	Active
ViSi	Thumb Tape (Qty 100)	FDA UDI	Class II	Active
ViSi	Mobile Monitor	FDA UDI	Class II	Active
ViSi	Disposable Adult Cuff, Large (Qty 20)	FDA UDI	Class II	Active
ViSi	Disposable Wrist Cradle, Large (Qty 20)	FDA UDI	Class II	Active
ViSi Mobile System Package	5-lead IEC	FDA UDI	Class II	Active
ViSi Mobile System Package	3-lead AAMI	FDA UDI	Class II	Active
ViSi	Chest Sensor, 3 Lead, AAMI, WH	FDA UDI	Class II	Active
ViSi	Reusable cNIBP & SpO2 Thumb Sensor	FDA UDI	Class II	Active
ViSi	ViSi Mobile Charger, 2-Bay	FDA UDI	Class II	Active
ViSi	ViSi Emergency Medical Surveillance (EMS) Kit	FDA UDI	Class II	Active
ViSi	Thumb Wrap (Qty 100)	FDA UDI	Class II	Active
ViSi	Disposable Adult Cuff, Large+ (Qty 20)	FDA UDI	Class II	Active
Visi Mobile Monitoring System	K130709	FDA 510(k)	Class II	Active
Visi Mobile Monitoring System, Visi Mobile Chest Sensor	K142827	FDA 510(k)	Class II	Active
ViSi Mobile Monitoring System	K152341	FDA 510(k)	Class II	Active
Visi Mobile Monitioring System	K133586	FDA 510(k)	Class II	Active
Visi Mobile Monitoring System	K122036	FDA 510(k)	Class II	Active
Visi Mobile Monitoring System	K112478	FDA 510(k)	Class II	Active
Visi Mobile Monitoring System	K143751	FDA 510(k)	Class II	Active
ViSi Mobile Monitoring System	K180472	FDA 510(k)	Class II	Active
ViSi Mobile Monitoring System	K150361	FDA 510(k)	Class II	Active

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FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
May 23, 2013	Z-1817-2013	—	terminated	Sotera Wireless, Inc. is recalling the ViSi Mobile Monitoring System due to the potential for the Chest Sensor to cause a blister wound.
May 23, 2013	Z-1818-2013	—	terminated	Sotera Wireless, Inc. is recalling the ViSi Mobile Monitoring System due to the potential for the Chest Sensor to cause a blister wound.