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510(k) K241004

Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2) by Huizhou Lvb Maternal and Infant Supplies Co., Ltd. — Product Code HGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2024
Date Received
April 12, 2024
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 Huizhou Lvb Maternal and Infant Supplies Co., Ltd.

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  • K230102 — Smart double sides wearable breast pump, Electric bilateral breast pump (September 21, 2023)

Other clearances for product code HGX

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  • K253946 — Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 (April 7, 2026)
  • K250208 — SPECTRA Wearable 2 (April 6, 2026)
  • K252744 — Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728) (April 3, 2026)
  • K252583 — Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) (March 12, 2026)
  • K253934 — Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, (March 9, 2026)
  • K252422 — Wearable Breast Pump (Model W2) (February 13, 2026)
  • K253149 — Motion InBra (YM-8801) wearable breast pump (February 13, 2026)