Skip to content

Tecarpuls II 1731931

by Zimmer MedizinSysteme GmbH

Tecarpuls II 1731931 is a medium-wave diathermy treatment system (FDA Class II; FDA product code PBX, Massager, Vacuum, Radio Frequency Induced Heat) made by Zimmer MedizinSysteme GmbH, cleared under FDA 510(k) K213256 on 25 May 2023 and listed in FDA GUDID since 12 Feb 2026 (UDI-DI 04053915986880), 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) K213256

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 Number04053915986880 UDI-DI Date12 Feb 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK213256 Date25 May 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K213256 decided 25 May 2023 Active
  • FDA GUDID UDI-DI 04053915986880 listed 12 Feb 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K213256
  2. Listed FDA GUDID 04053915986880

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Tecarpuls II
Generic name
Medium-wave diathermy treatment system
Model / Ref / Catalog
1731931
Primary DI / UDI-DI
04053915986880
510(k) Number
FDA product code
PBX
GMDN term
Medium-wave diathermy treatment system
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K213256)

Similar devices

Other devices filed under FDA product code PBX (Massager, Vacuum, Radio Frequency Induced Heat).

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)