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Human Tecar CAP electrode Ø 80 mm

by Unibell SRL

Human Tecar CAP electrode Ø 80 mm (16462) is a medium-wave diathermy treatment system (FDA Class II; FDA product code PBX, Massager, Vacuum, Radio Frequency Induced Heat) made by Unibell SRL, cleared under FDA 510(k) K181211 on 10 Sep 2018 and listed in FDA GUDID since 15 Jun 2019 (UDI-DI 08056182720870), 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) K181211

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 Number08056182720870 UDI-DI Date15 Jun 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK181211 Date10 Sep 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K181211 decided 10 Sep 2018 Active
  • FDA GUDID UDI-DI 08056182720870 listed 15 Jun 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K181211
  2. Listed FDA GUDID 08056182720870

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Human Tecar
Generic name
Medium-wave diathermy treatment system
Model / Ref / Catalog
CAP electrode Ø 80 mm, 16462
Primary DI / UDI-DI
08056182720870
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 (K181211)

and 8 more cleared under K181211

Similar devices

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

Other devices from Unibell SRL

See all devices from Unibell SRL →

Properties

  • Lot / batch number
Other properties (14, all answered No)