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Indiba Activ - AT7 ACT0407USA

by Indiba SA.

Indiba Activ - AT7 ACT0407USA is a medium-wave diathermy treatment system (FDA Class II; FDA product code PBX, Massager, vacuum, radio frequency induced heat) made by Indiba SA., cleared under FDA 510(k) K161458 on 3 Oct 2016 and listed in FDA GUDID since 6 Apr 2021 (UDI-DI 08434251000915), active as of 23 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 23 Oct 2026

Documents

510(k) K161458

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08434251000915 UDI-DI Date6 Apr 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK161458 Date3 Oct 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K161458 decided 3 Oct 2016 Active
  • FDA GUDID UDI-DI 08434251000915 listed 6 Apr 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K161458
  2. Listed FDA GUDID 08434251000915

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Indiba Activ - AT7
Generic name
Medium-wave diathermy treatment system
Model / Ref / Catalog
ACT0407USA, AT7
Primary DI / UDI-DI
08434251000915
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

Category: Medium-wave diathermy treatment system

Cleared under the same submission (K161458)

and 6 more cleared under K161458

Similar devices

Other devices filed under FDA product code PBX (Massager, vacuum, radio frequency induced heat).

Other devices from Indiba SA.

See all devices from Indiba SA. →

Properties

  • Over-the-counter
  • Combination product
  • Lot / batch number
  • Serial number
  • Expiration date
Other properties (10, all answered No)