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Compower NPVC-001/RTMA

by Xiamen Compower Medical Tech. Co., Ltd 2 variants

Compower NPVC-001/RTMA is a Class II device made by Xiamen Compower Medical Tech. Co., Ltd, cleared under FDA 510(k) K210288 on 26 Aug 2021 and listed in FDA GUDID since 15 Sep 2021 (UDI-DI 06946430410849), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K210288

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06946430410849 UDI-DI Date15 Sep 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK210288 Date26 Aug 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K210288 decided 26 Aug 2021 Active
  • FDA GUDID UDI-DI 06946430410849 listed 15 Sep 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K210288
  2. Listed FDA GUDID 06946430410849

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Compower
Generic name
Pulmonary resuscitator, manual, single-use
Model / reference
NPVC-001/RTMA
Primary DI / UDI-DI
06946430410849
510(k) Number
FDA product code
BTM
GMDN term
Pulmonary resuscitator, manual, single-use
Device class
Class II
Regulation number
868.5915
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Pulmonary resuscitator, manual, single-use.

Other devices from Xiamen Compower Medical Tech. Co., Ltd.

See all devices from Xiamen Compower Medical Tech. Co., Ltd. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)