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510(k) K250463

Ameda GLO Wearable Breast Pump (Model W8S) by Shenzhen TPH Technology Co., Ltd. — Product Code HGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2025
Date Received
February 18, 2025
Clearance Type
Special
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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  • 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)
  • K251423 — Spectra S1 Pro; Spectra S2 Pro (February 6, 2026)
  • K253498 — Pump In Style® Pro+ (January 22, 2026)
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  • K252754 — Wearable Electric Breast Pump (YM-8803) (December 19, 2025)
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