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PowerDot PD-01B

by ZMI Electronics Ltd.

PowerDot PD-01B is a Class II device made by ZMI Electronics Ltd., listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04719872330318), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04719872330318 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
PowerDot
Generic name
Multi-modality physical therapy system, simultaneous, professional-use
Model / Ref / Catalog
PD-01B, PD-01
Primary DI / UDI-DI
04719872330318
FDA product code
NGX
GMDN term
Multi-modality physical therapy system, simultaneous, professional-use
Device class
Class II
Regulation number
890.5850
GUDID distribution status
In Commercial Distribution

Related devices

Category: Physical therapy ultrasound/neuromuscular stimulation system

Similar devices

Other devices filed under FDA product code NGX (Stimulator, Muscle, Powered, For Muscle Conditioning).

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See all devices from Zmi Elecronics, Ltd. →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)