FDA.reportPublic FDA data

CIONIC

Primary DI
G345SL2000
Brand
CIONIC
Company
Cionic, Inc.
Model
NS-200
Catalog number
NS200
Device description
Cionic Neural Sleeve NS-200
Published
2026-06-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
GZIStimulator, Neuromuscular, External Functional
HCCDevice, Biofeedback
IPFStimulator, Muscle, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZIStimulator, Neuromuscular, External FunctionalNeurology2
HCCDevice, BiofeedbackNeurology2
IPFStimulator, Muscle, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243828000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243828000CIONIC NEURAL SLEEVE (NS-200)Cionic, Inc.2025-05-02GZI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G345SL2000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Gait-enhancement electrical stimulation system, externalAn assembly of devices that applies electrical stimuli to the lower extremity nerves (e.g., peroneal or femoral) or muscles (e.g., those that cause ankle dorsiflexion), to cause the muscles in the leg to contract, thus improving the gait in a patient suffering from partial paralysis of the lower extremities or other neuromuscular disorders. It typically includes electrodes and an external pulse generator (EPG), and may be incorporated into an external prosthesis.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Regulatory Flags#

DUNS number
081351601
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G345DC1000CIONICDC-100DC1002024-01-26
G345SL1000CIONICSL-100SL1002024-01-26
G345NS1000CIONICNS-100NS1002022-12-15
G345620000030CIONIC10620000032022-12-01
G345620000040CIONIC10620000042022-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06977444420005Shuhai JingweiShuhai Jingwei (Shenzhen) Information Technology Co., Ltd.HCC2026-09-04
00884400829658Hubble-24AMAZE Neuro, Inc.HCC2026-08-27
00884400833297Voyager-7AMAZE Neuro, Inc.HCC2026-08-27
06971712726417NourishnestHong Qiangxing (Shen Zhen) Electronics LimitedIPF2026-07-29
08032625829843NerveOTXDOMINO SRLIPF2026-07-28
00860015825803JOGO-GxJogohealth, Inc.HCC2026-07-27
06971712725359DOMASHong Qiangxing (Shen Zhen) Electronics LimitedIPF2026-07-09
06971712722693DOMASHong Qiangxing (Shen Zhen) Electronics LimitedIPF2026-07-09
07540191000678NeuroInfinitiThought Technology Ltd.HCC2026-07-06
06971712727636ONENTECHHong Qiangxing (Shen Zhen) Electronics LimitedIPF2026-07-03
08809851470145WavefacialWEERO Co., Ltd.IPF2026-06-22
03770018808086actiTENSSUBLIMEDIPF2026-05-27
03770018808093actiTENSSUBLIMEDIPF2026-05-27
03770018808109actiTENSSUBLIMEDIPF2026-05-27
03770018808116actiTENSSUBLIMEDIPF2026-05-27
03770018808253actiTENS MiniSUBLIMEDIPF2026-05-27
03770018808260actiTENS MiniSUBLIMEDIPF2026-05-27
04048223122235Stim2GoPajunk GmbH MedizintechnologieIPF2026-05-21
08809308380041Talent-pro Electromagnetic StimulatorREMED Co.,Ltd.IPF2026-05-13
07898966442551IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
07898966442698IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
08032625824480GLOBUSDOMINO SRLIPF2026-02-23
08719481550110NeXus 10 MK3Mind Media Europe B.V.HCC2025-09-10
08885022060018Quantum Mitohormesis (QMT)QUANTUMTX PTE. LTD.IPF2025-07-21
50885380198791KangarooCardinal Health 200, LLCHCC2025-03-12
08720618311139Sonopuls 494Enraf-Nonius B.V.IPF2025-02-11
08032625822868GLOBUSDOMINO SRLIPF2024-11-20
08032625822875GLOBUSDOMINO SRLIPF2024-11-20
08032625822882GLOBUSDOMINO SRLIPF2024-11-20
08809851470053eMVFitWEERO Co., Ltd.IPF2024-10-22