BIONESS MEDICAL, INC.

FDA Device Registration & Listing · Valencia, CA, US · Registration 3036471706

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
3036471706
FEI Number
3036471706
Entity Name
BIONESS MEDICAL, INC.
City/State/Country
Valencia, CA, US
Establishment Address
25103 Rye Cyn Loop, Valencia, CA 91355, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Bioness Medical, Inc. (Owner Number: 10092201)
Owner / Operator Contact Address
25103 Rye Cyn Loop, Valencia, CA 91355, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

PoNS L100 Go System L300 Go System Vector Base L300 Go System H200 Wireless System BITS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QCF Electrical Tongue Stimulator To Treat Motor Deficits Neurology Class 2 882.5889 2026-04-13
GZI Stimulator, Neuromuscular, External Functional Neurology Class 2 882.5810 2024-12-12
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2024-12-12
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2024-12-12
GZI Stimulator, Neuromuscular, External Functional Neurology Class 2 882.5810 2024-12-12
ION Exerciser, Non-Measuring Physical Medicine Class 1 890.5370 2025-02-28
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2025-05-30
GZI Stimulator, Neuromuscular, External Functional Neurology Class 2 882.5810 2025-05-30
GZI Stimulator, Neuromuscular, External Functional Neurology Class 2 882.5810 2024-12-12
IKK System, Isokinetic Testing And Evaluation Physical Medicine Class 2 890.1925 2024-12-17

Official Correspondent

Christopher Swanson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Bioness Medical, Inc.
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

Similar Registrations

Registration Number Establishment Name Location
3015259856 HELIUS MEDICAL, INC Newtown, PA, US
3020683829 SUZHOU FAST ATM ELECTRIC CO., LTD Suzhou Jiangsu, CN
3005344585 ODSTOCK MEDICAL LTD SALISBURY Wiltshire, GB
3038295706 JUST KEEP HEALTHY CO., LTD. Samkkei Munichay District Kampong Speu, KH
3019892999 CIONIC Facility Scotts Valley, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3036471706. Last updated year: 2026. Please use registration number 3036471706 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.