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PowerDot SAE-MC-PD-01MTBL

by ZMI Electronics Ltd.

PowerDot SAE-MC-PD-01MTBL is a Class II device made by ZMI Electronics Ltd., cleared under FDA 510(k) K180865 on 28 Jun 2018 and listed in FDA GUDID since 10 Dec 2019 (UDI-DI 04719872330622), active as of 23 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 23 Oct 2026

Documents

510(k) K180865

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04719872330622 UDI-DI Date10 Dec 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK180865 Date28 Jun 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K180865 decided 28 Jun 2018 Active
  • FDA GUDID UDI-DI 04719872330622 listed 10 Dec 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K180865
  2. Listed FDA GUDID 04719872330622

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
PowerDot
Generic name
Neuromuscular transmission electrode
Model / reference
SAE-MC-PD-01MTBL
Description
Self-adhesive electrode package (with magnetic snap) , Blue, Each package contains electrode dia.55mm (2pcs) + 50mm*90mm (1pcs)
Primary DI / UDI-DI
04719872330622
510(k) Number
FDA product code
GXY
GMDN term
Neuromuscular transmission electrode
Device class
Class II
Regulation number
882.1320
GUDID distribution status
In Commercial Distribution

Related devices

Category: Neuromuscular transmission electrode

Cleared under the same submission (K180865)

and 2 more cleared under K180865

Similar devices

Other devices filed under FDA product code GXY (Electrode, Cutaneous).

Other devices from Zmi Elecronics, Ltd.

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  • Levina RS-48

    Class II

See all devices from Zmi Elecronics, Ltd. →

Properties

  • Lot / batch number
  • Manufacturing date
Other properties (13, all answered No)