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510(k) Data Aggregation
K Number
K162415Device Name
Spectra 9Plus
Manufacturer
Uzinmedicare Company
Date Cleared
2017-03-15
(198 days)
Product Code
HGX, CLA
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
Uzinmedicare Company
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spectra 9Plus is a single user, powered breast pump intended to express and collect milk from the breasts of lactating women.
Device Description
The Spectra 9Plus is a single-user, powered breast pump intended to express and collect milk from the breasts of lactating women. The device is intended to be a single patient reusable device. The device is capable of single and dual pumping.
The Spectra 9Plus is powered by a 9V DC adaptor or rechargeable Lithium ion battery. It is composed of materials commonly found in medical devices such as polypropylene, ABS, and silicone. All milk-contacting components are constructed out of food-grade materials that are compliant with 21 C.F.R. parts 174-179.
The Spectra 9Plus is considered a skin-contacting device with a limited (≤24 hours) contact duration.
The user employs buttons to switch from massage mode to expression mode and to control the vacuum and cycle levels within those modes. Massage mode consists of 5 suction levels and 1 cycling speed, while expression mode has 10 suction levels and 10 cycling speeds. The Spectra 9Plus is capable of providing vacuum levels from 50-270 mmHg with cycling rates up to 70 cycles per minute.
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