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510(k) K212180

Wearable Breast Pump (Model S12) by Shenzhen TPH Technology Co., Ltd. — Product Code HGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2022
Date Received
July 12, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Breast, Powered
Device Class
Class II
Regulation Number
884.5160
Review Panel
OB
Submission Type

Other clearances by Shenzhen TPH Technology Co., Ltd.

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  • K250350 — Thrive 2-in-1 Breast Pump (Model P3) (July 15, 2025)
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  • K250368 — Wearable Breast Pump (Model S21) (May 30, 2025)
  • K243508 — Wearable breast pump (model S12A) (April 21, 2025)
  • K250829 — Lacevo Wearable Breast Pump (Model S70) (April 17, 2025)

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  • K252422 — Wearable Breast Pump (Model W2) (February 13, 2026)
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  • K252754 — Wearable Electric Breast Pump (YM-8803) (December 19, 2025)
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