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Replexa+ Treatment Applicator C1416

by Promedtek, Inc.

Replexa+ Treatment Applicator C1416 is a Class II device made by Promedtek, Inc., cleared under FDA 510(k) K162240 on 17 Nov 2016 and listed in FDA GUDID since 8 Jul 2019 (UDI-DI 00850886008016), 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) K162240

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 Number00850886008016 UDI-DI Date8 Jul 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK162240 Date17 Nov 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K162240 decided 17 Nov 2016 Active
  • FDA GUDID UDI-DI 00850886008016 listed 8 Jul 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K162240
  2. Listed FDA GUDID 00850886008016

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Replexa+ Treatment Applicator
Generic name
Short-wave diathermy treatment system, professional
Model / reference
C1416
Primary DI / UDI-DI
00850886008016
510(k) Number
FDA product code
IMJ
GMDN term
Short-wave diathermy treatment system, professional
Device class
Class II
Regulation number
890.5290
GUDID distribution status
In Commercial Distribution

Related devices

Category: Short-wave diathermy treatment system, professional

Cleared under the same submission (K162240)

Similar devices

Other devices filed under FDA product code IMJ (Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat).

Other devices from Promedtek, Inc.

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)