Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016569182

FEI Number

3016569182

Entity Name

BIOXTREME

City/State/Country

Petach Tikva Central, IL

Establishment Address

7 Imber Street, Petach Tikva Central 4951141, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BioXtreme (Owner Number: 10062549)

Owner / Operator Contact Address

4 Hatnufa Street, Petach Tikva, IL-M 4951022, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PlaXtreme

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PKS	Exerciser, Non-Measuring For Stroke Rehabilitation	Physical Medicine	Class 1	890.5370	2024-11-18

Official Correspondent

Yoram Levy

US Agent Details

Tova Rivnay Email: tova@qsitemed.com Phone: (512) 5354930

Related Public Records

Same Entity

BioXtreme

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016569182. Last updated year: 2026. Please use registration number 3016569182 when referencing this establishment in official correspondence.