Skip to content

PowerDot PD-01MR

by ZMI Electronics Ltd.

PowerDot PD-01MR is a multi-modality physical therapy system (FDA Class II; FDA product code NGX, Stimulator, Muscle, Powered, For Muscle Conditioning) made by ZMI Electronics Ltd., listed in FDA GUDID since 12 Feb 2018 (UDI-DI 04719872330394), 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 Number04719872330394 UDI-DI Date12 Feb 2018ListedStatusListed 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  • Withdrawn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-01MR, PD-01M
Primary DI / UDI-DI
04719872330394
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).

Other devices from Zmi Elecronics, Ltd.

  • Levina PFR-01-NS

    Class II

  • Levina PFR-03-NS

    Class II

  • Levina PFR-02-NS

    Class II

  • Levina RS-48

    Class II

See all devices from Zmi Elecronics, Ltd. →

Properties

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