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Wonder Touch WONDER00001

by XOD Inc

Wonder Touch WONDER00001 is a medium-wave diathermy treatment system (FDA Class II; FDA product code PBX, Massager, Vacuum, Radio Frequency Induced Heat) made by XOD Inc, cleared under FDA 510(k) K242175 on 27 Feb 2025 and listed in FDA GUDID since 1 Jul 2025 (UDI-DI D650WONDER1), 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) K242175

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 NumberD650WONDER1 UDI-DI Date1 Jul 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK242175 Date27 Feb 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K242175 decided 27 Feb 2025 Active
  • FDA GUDID UDI-DI D650WONDER1 listed 1 Jul 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K242175
  2. Listed FDA GUDID D650WONDER1

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Wonder Touch
Generic name
Medium-wave diathermy treatment system
Model / reference
WONDER00001
Primary DI / UDI-DI
D650WONDER1
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

Similar devices

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

Other devices from XOD Inc

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)