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Cionic Ns-200

by Cionic, Inc.

Cionic Ns-200 (NS200) is a Class II device made by Cionic, Inc., cleared under FDA 510(k) K243828 on 2 May 2025 and listed in FDA GUDID since 4 Jun 2026 (UDI-DI G345SL2000), 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) K243828

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 NumberG345SL2000 UDI-DI Date4 Jun 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK243828 Date2 May 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K243828 decided 2 May 2025 Active
  • FDA GUDID UDI-DI G345SL2000 listed 4 Jun 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K243828
  2. Listed FDA GUDID G345SL2000

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Cionic
Generic name
Gait-enhancement electrical stimulation system, external
Model / Ref / Catalog
NS-200, NS200
Primary DI / UDI-DI
G345SL2000
510(k) Number
FDA product code
GZI, HCC, IPF
GMDN term
Gait-enhancement electrical stimulation system, external
Device class
Class II
Regulation number
882.5810, 882.5050, 890.5850
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code GZI (Stimulator, Neuromuscular, External Functional).

Other devices from Cionic, Inc.

See all devices from Cionic, Inc. →

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
Other properties (12, all answered No)