CIONIC Facility

FDA Device Registration & Listing · Scotts Valley, CA, US · Registration 3019892999

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3019892999
FEI Number
3019892999
Entity Name
CIONIC Facility
City/State/Country
Scotts Valley, CA, US
Establishment Address
1500 Green Hills Rd, Suite 109, Scotts Valley, CA 95066, US
Establishment Type(s)
Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
CIONIC (Owner Number: 10082455)
Owner / Operator Contact Address
1500 Green Hills Rd, STE 109, Scotts Valley, CA 95066, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Cionic Neural Sleeve NS-200 Cionic Neural Sleeve NS-100 Cionic Neural Sleeve NS-100

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GZI Stimulator, Neuromuscular, External Functional Neurology Class 2 882.5810 2025-09-11
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2025-09-11
HCC Device, Biofeedback Neurology Class 2 882.5050 2025-09-11
GZI Stimulator, Neuromuscular, External Functional Neurology Class 2 882.5810 2023-01-27
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2023-01-27
GZI Stimulator, Neuromuscular, External Functional Neurology Class 2 882.5810 2022-05-16
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2022-05-16

Official Correspondent

Domenico Pisaturo

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CIONIC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K030403 Cefar Medical AB CEFAR REHAB 2 AND REHAB 2 PRO 2003-07-17
K231440 Shenzhen Roundwhale Technology Co. , Ltd. Combo Electrotherapy Device 2023-11-03
K820884 Nitron Electronics ELECTRICAL MUSCLE STIMULATOR 1982-04-29
K201958 Therasigma, LLC ETD Family of Electrotherapy Devices 2020-08-04
K964028 Mettler Electronics Corp. SYS STIM 226 1997-02-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019892999. Last updated year: 2026. Please use registration number 3019892999 when referencing this establishment in official correspondence.
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