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Magsculpt Mst-1001

by K1MEDGLOBAL Co., Ltd.

Magsculpt Mst-1001 is a deep-tissue electromagnetic stimulation system (FDA Class II; FDA product code NGX, Stimulator, Muscle, Powered, For Muscle Conditioning) made by K1MEDGLOBAL Co., Ltd., cleared under FDA 510(k) K222400 on 27 Feb 2024 and listed in FDA GUDID since 13 Mar 2025 (UDI-DI 08809956800151), 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) K222400

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 Number08809956800151 UDI-DI Date13 Mar 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK222400 Date27 Feb 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K222400 decided 27 Feb 2024 Active
  • FDA GUDID UDI-DI 08809956800151 listed 13 Mar 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K222400
  2. Listed FDA GUDID 08809956800151

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Magsculpt
Generic name
Deep-tissue electromagnetic stimulation system, professional
Model / reference
MST-1001
Primary DI / UDI-DI
08809956800151
510(k) Number
FDA product code
NGX
GMDN term
Deep-tissue electromagnetic stimulation system, professional
Device class
Class II
Regulation number
890.5850
GUDID distribution status
In Commercial Distribution

Related devices

Category: Deep-tissue electromagnetic stimulation system, professional

Cleared under the same submission (K222400)

Similar devices

Other devices filed under FDA product code NGX (Stimulator, Muscle, Powered, For Muscle Conditioning).

Other devices from K1MEDGLOBAL Co., Ltd.

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)