Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8032035

FEI Number

3003716588

Entity Name

MASTERCARE AB

City/State/Country

SKARA Varmland, SE

Establishment Address

SMEDSTORPSGATAN 16, SKARA Varmland 53237, SE

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

MASTERCARE AB (Owner Number: 8032035)

Owner / Operator Contact Address

SMEDSTORPSGATAN 16, SKARA, SE-NOTA 53237, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Swedish Backcare System Mastercare Mastercare - The Swedish Back Care System Back-A-Traction

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	1990-01-19

Official Correspondent

MAGNUS JANSSON

US Agent Details

Jerry Doane Business: Pragmatic Compliance dba FDAbasics Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

MASTERCARE AB

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3013132310	FUKO INC.	Taichung, TW
3031209582	BLOCK THERAPY LTD	Winnipeg Manitoba, CA
3010163710	KUNSHAN CHENGYI GARMENT FACTORY	Kunshan Jiangsu, CN
3010393580	ARTIC BITES, LLC	Findlay, OH, US
3021194555	SALUTE REHAB, LTD.	Karmi'El Northern, IL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8032035. Last updated year: 2026. Please use registration number 8032035 when referencing this establishment in official correspondence.