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ZStim PTG-05

by Zimmer MedizinSysteme GmbH

ZStim PTG-05 (6222) 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) K240347 on 21 Jul 2024 and listed in FDA GUDID since 29 Jul 2024 (UDI-DI 04053815087410), 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) K240347

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 Number04053815087410 UDI-DI Date29 Jul 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK240347 Date21 Jul 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K240347 decided 21 Jul 2024 Active
  • FDA GUDID UDI-DI 04053815087410 listed 29 Jul 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K240347
  2. Listed FDA GUDID 04053815087410

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ZStim
Generic name
Deep-tissue electromagnetic stimulation system, professional
Model / Ref / Catalog
PTG-05, 6222
Primary DI / UDI-DI
04053815087410
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)