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510(k) Data Aggregation
K Number
K220926Device Name
Spectra Wearable
Manufacturer
Uzinmedicare Co., Ltd.
Date Cleared
2022-12-12
(256 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
Uzinmedicare Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spectra Wearable is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Spectra Wearable is intended for a single user.
Device Description
The SPECTRA WEARABLE is a powered breast pump that is intended to express and collect milk from the breasts of lactating women. This breast pump is intended for use by a single user and can be used to pump breast milk from a single breast (single pumping). It is designed to work in the user's bra and is battery operated so it can be used hands-free without external power cords. The device is provided non-sterile. The SPECTRA WEARABLE allows the user to adjust the vacuum levels. Two suction patterns, massage and expression mode, are pre-programmed with variable levels and cycle speeds. The subject device is powered by a rechargeable Li-polymer battery (3.7 V, 1500 mAh).
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K Number
K210124Device Name
Synergy Gold (SG) Portable (Models MM011450 and MM011460)
Manufacturer
Uzinmedicare Co.
Date Cleared
2021-10-19
(273 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
Uzinmedicare Co.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Synergy Gold (SG) Portable (Models MM011450 and MM011460) is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Synergy Gold (SG) Portable (Models MM011450 and MM011460) breast pump is intended for home use by a single user.
Device Description
The Synergy Gold (SG) Portable is a powered breast pump intended to express and collect milk from the breasts of lactating women. Pumping can be performed on one breast (single pumping) or both breasts (double pumping) at the same time. The user employs buttons to select one or both sides for pumping, to switch from massage mode to expression mode and to control the vacuum levels within those modes. Massage mode consists of 5 suction levels, while expression mode has 12 suction levels. The SG Portable breast pump is capable of providing vacuum levels from 50-270 mmHz with cycling rate or 100 cycles per minute in massage mode and 26 cycles per minute in expression mode. The SG Portable breast pump is powered by a 5V DC adaptor or an internal rechargeable lithium-ion polymer battery.
The SG Portable breast pump is sold in two configurations (with and without breast shield and bottle sets). Model MM011450 includes the SG Portable breast pump, double collection kit (MM12302-C; breast shield set - medium 24 mm), power adapter, and two collection bottles. Model MM011460 includes the SG Portable breast pump and power adaptor: this model is to be used with separately purchased compatible breast shields and bottle sets.
The SG Portable breast pump and associated breast pump kits are intended for a single user.
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K Number
K191109Device Name
Spectra Q
Manufacturer
Uzinmedicare Co.
Date Cleared
2020-01-22
(271 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
Uzinmedicare Co.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spectra Q is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Spectra Q is intended for home use by a single user.
Device Description
The Spectra Q breast pump is comprised of a Spectra Q pump, breast shield (20, 24, 28, 32 mm), backflow protector, silicone valve, tubing, bottles (including the nipple, cap, cover, and disk), 2-wav connector (for double pumping), and power adapters. The breast pump is provided with one 24 mm and one 28 mm breast shield. Optional components include a small cap converter, assembled with the feeding bottle, the 20 and 32 mm breast shields, and a wide bottle stand. The Spectra Q breast pump is used by lactating women to express and collect milk from their breasts. The pump is intended for home use by a single user. Pumping with the Spectra Q breast pump can be performed on one breast (single pumping) or on both breasts at the same time (double pumping). The Spectra O breast pump allows the user to adjust the vacuum levels. Two suction patterns, massage and expression mode, are pre-programmed with variable vacuum levels and cycle rates (pump speed). The powered breast pump is capable of providing vacuum levels from -50 to -270 mmHq with cycle rates up to 110 cycles per minute. The device is powered by a 6 V AC/DC power adapter or a 5 V USB C type power adapter. The device is provided non-sterile.
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K Number
K191208Device Name
Spectra Cashmere
Manufacturer
Uzinmedicare Co.
Date Cleared
2019-10-11
(158 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
Uzinmedicare Co.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spectra Cashmere breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Spectra Cashmere breast pump is intended for multiple users in a hospital setting. It is also intended for home use by a single user.
Device Description
The Spectra Cashmere is a powered breast pump intended to express and collect milk from the breasts of lactating women. Two models are available:
- Model MM010035 is the retail model, which includes the breast pump Part # IMP-0034, double collection kit, ac adapter, and 2 collection bottles.
- MM010035-H is multi-user hospital grade model, which includes the breast pump . Part # IMP-0034 and ac adapter only.
The Spectra Cashmere component(s) consist of:
- Spectra Cashmere pump with ABS housing, .
- Breast shield set, includes polypropylene flange (size 20, 24, 28 and 32 mm), . backflow protector, valve, tubing,
- 12V AC power adapter, ●
- Bottle set (bottle, nipple, cap, disk, cover). .
Pumping can be performed on one breast (single pumping) or both breasts (double pumping) at the same time. The user employs buttons to select one or both sides for pumping, 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 5 cycling speed options, while expression mode has 15 suction levels and 5 cycle speed levels.
The Spectra Cashmere includes a diaphragm pump using two motors, one for each breast, to generate vacuum for breastmilk expression. Backflow protection is provided by the breast pump set's backflow protector. The silicone membrane backflow protector serves as a barrier between the breast shield and collection bottle (user side) and the tubing connected to the pump (pump side) to prevent the introduction of any fluids into the tubing or the pump's housing, thus preventing cross-contamination between users.
The Spectra Cashmere breast pump is capable of providing vacuum levels from 50-270 mmHg with cycling rates up from 38 to 76 cycles per minute. The Spectra Cashmere breast pump is powered by a 12V DC adaptor.
The Spectra Cashmere breast pump is a non-sterile device intended for repeated use by multiple users in a hospital setting. It is also intended for repeated use in the home use by a single user.
Kits used with the Spectra Cashmere are intended for a single user in either the home or hospital environment. The polypropylene breast shields used with the Spectra Cashmere breast pump have direct contact with the user's intact skin. Contact duration is prolonged considering cumulative use of the device.
The Spectra Cashmere breast pump includes software.
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K Number
K181784Device Name
Spectra S3 Plus
Manufacturer
Uzinmedicare Co.
Date Cleared
2018-11-30
(150 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
Uzinmedicare Co.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spectra 3 Plus Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Spectra 3 Plus Breast Pump is intended for multiple users in a hospital setting. It is also intended for home use by a single user.
Device Description
The Spectra S3 Plus is a powered breast pump intended to express and collect milk from the breasts of lactating women. Pumping can be performed on one breast (single pumping) or both breasts (double pumping) at the same time. 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 option, while expression mode has 12 suction levels and 5 cycle speed levels. The Spectra S3 Plus is capable of providing vacuum levels from 50-270 mmHg with cycling rates up to 70 cycles per minute. The Spectra S3 Plus is powered by a 12V DC adaptor or rechargeable lithium battery. The Spectra S3 Plus breast pump can be used by multiple users. Kits used with the Spectra S3 Plus breast pump, however, are labeled for a single user.
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K Number
K150476Device Name
Spectra S1Plus and Spectra S2 Plus
Manufacturer
UZINMEDICARE CO.
Date Cleared
2016-04-15
(416 days)
Product Code
HGX, SPE
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
UZINMEDICARE CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spectra S1 Plus and Spectra S2 Plus are single-user, powered breast pumps intended to express and collect milk from the breasts of lactating women.
Device Description
The Spectra S1 Plus and Spectra S2 Plus are single-user, powered breast pumps intended to express and collect milk from the breasts of lactating women. Pumping can be performed on one breast (single pumping) or both breasts (double pumping) at the same time. 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 option, while expression mode has 12 suction levels and 5 cycle speed levels. The Spectra S1 Plus and Spectra S2 Plus are capable of providing vacuum levels from 50-280 mmHg with cycling rates up to 70 cycles per minute. The Spectra S1 Plus is powered by a 12V DC adaptor or rechargeable lithium battery. The Spectra S2 Plus is powered only by a 12V DC adaptor.
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K Number
K093145Device Name
SPECTRA SERIES BREAST PUMP
Manufacturer
UZINMEDICARE CO.
Date Cleared
2010-08-13
(312 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
UZINMEDICARE CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spectra electric breast pump is Single user product and intended to express breast milk from the breast of lactating woman.
Device Description
The Spectra Series Breast Pump is operated by AC motor, The device's motor drives a Piston pump, creating a vacuum to express breast milk. Passing through an air tubing to breast shield, the vacuum is used to comfortably draw out the breast milk.
This device operates with power ON at the same time. Also, vacuum regulate operates, and I adjust a vacuum. ON, OFF of a device means opening of absorption and end.
Regular this which is international or foods of FDA shall obey it to safe sanitary rules etc. related to contacts of mother's milk that I faced it to things come in contact on matter or human chest etc.
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