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emFieldPro 5032

by Zimmer MedizinSysteme GmbH

emFieldPro 5032 is a deep-tissue electromagnetic stimulation system (FDA Class II; FDA product code NGX, Stimulator, Muscle, Powered, For Muscle Conditioning) made by Zimmer MedizinSysteme GmbH, cleared under FDA 510(k) K182963 on 21 Jun 2019 and listed in FDA GUDID since 12 Jul 2019 (UDI-DI 04053815074151), 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) K182963

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 Number04053815074151 UDI-DI Date12 Jul 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK182963 Date21 Jun 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K182963 decided 21 Jun 2019 Active
  • FDA GUDID UDI-DI 04053815074151 listed 12 Jul 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K182963
  2. Listed FDA GUDID 04053815074151

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
emFieldPro
Generic name
Deep-tissue electromagnetic stimulation system, professional
Model / Ref / Catalog
5032
Primary DI / UDI-DI
04053815074151
510(k) Number
FDA product code
NGX
GMDN term
Deep-tissue electromagnetic stimulation system, professional
Device class
Class II
Regulation number
890.5850
GUDID distribution status
In Commercial Distribution

Related devices

Category: Deep-tissue electromagnetic stimulation system, professional

Similar devices

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

Other devices from Zimmer Medizinsystems GmbH

See all devices from Zimmer Medizinsystems GmbH →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)