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510(k) K260864

Mother's Nature W1 Warming Wearable Breast Pump by Shenzhen TPH Technology Co., Ltd. — Product Code HGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2026
Date Received
March 17, 2026
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.

  • K254244 — Wearable Breast Pump (Model S39) (May 21, 2026)
  • K260033 — Wearable Breast Pump (Model S21A) (April 8, 2026)
  • K252420 — Wearable Breast Pump (Model W12) (February 13, 2026)
  • K252422 — Wearable Breast Pump (Model W2) (February 13, 2026)
  • K251754 — Wearable Breast Pump (Model S33) (September 8, 2025)
  • K250383 — Wearable Breast Pump (Model W6) (August 20, 2025)
  • K250843 — Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) (July 31, 2025)
  • K250350 — Thrive 2-in-1 Breast Pump (Model P3) (July 15, 2025)
  • K250368 — Wearable Breast Pump (Model S21) (May 30, 2025)
  • K250365 — Motif Aura Glow breast pump (Model Motif Aura Glow) (May 30, 2025)

Other clearances for product code HGX

  • K254254 — Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) (June 18, 2026)
  • K260538 — Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) (June 17, 2026)
  • K260346 — Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H11 (June 12, 2026)
  • K250129 — AViTA Breast Pump (June 11, 2026)
  • K260956 — Spectra Platinum Mini (June 4, 2026)
  • K254300 — eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T600 (May 29, 2026)
  • K254244 — Wearable Breast Pump (Model S39) (May 21, 2026)
  • K254125 — Electric Breast Pump (HL-3058 II Pro) (May 13, 2026)
  • K253914 — Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, (April 29, 2026)
  • K260239 — Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862) (April 22, 2026)