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Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862)

by Jiangxi AOV Maternity & Baby Products Co., Ltd.

510(k) K260239

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK260239 Date22 Apr 2026ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HGX
Device Class
Class II
Regulation
21 CFR Part 884.5160
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

A wearable breast pump is a powered device intended to express milk from the breasts of lactating women. It is designed for use by a single user and is substantially equivalent to legally marketed devices as determined through the FDA 510(k) process.

The device is supplied as a wearable breast pump system with model numbers AOV6853, AOV6860, AOV6861, and AOV6862. It is manufactured by Jiangxi AOV Maternity & Baby Products Co., Ltd. and has received FDA 510(k) clearance under K260239, with regulation number 884.5160 and product code HGX.

Other devices from Jiangxi AOV Maternity & Baby Products Co., Ltd.