Perifit Pump

510(k) Number

K231785 ↗

FDA product code

HGX

Device class

Class II

Regulation

21 CFR Part 884.5160

Advisory committee

Obstetrics/Gynecology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code HGX (Pump, Breast, Powered).

• Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728) by Cixi Ruihong Electric Appliance Co., Ltd.
• Electric Breast Pump by Ningbo Huiyoo Baby Products Co., Ltd.
• SPECTRA SERIES BREAST PUMP by UZINMEDICARE CO., LTD
• Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) by Shenzhen TPH Technology Co., Ltd
• Wearable Breast Pump (Model S21A) by Shenzhen TPH Technology Co., Ltd
• OPERA, OPERA eco by Unimom.Co
• WHITE RIVER AUTOMATIC BREAST PUMP by White River Concepts
• GENTLE EXPRESSIONS ELECTRIC BREAST PUMP by Healthteam
• EVENFLO COMFORT CONTROL BREAST PUMP, EVENFLO COMFORT CONTROL DUAL BREAST PUMP by Evenflo Company, Inc.
• Spectra S3 Plus by UZINMEDICARE CO., LTD

• Perifit Pink Perifit

  Class II

  FDA 510(k) K221476 Active Cleared 10 Feb 2023 GUDID on market

• Perifit Care+ Purple Perifit Care+

  Class II

  FDA 510(k) K231780 Active Cleared 20 Dec 2023 GUDID on market

• Perifit Pump 24mm

  Class II

  FDA 510(k) K231785 Active Cleared 26 Jan 2024 GUDID on market

• Hinge Health Pelvic Trainer by Perifit 900-00110

  Class II

  FDA 510(k) K221476 Active Cleared 10 Feb 2023 GUDID on market

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