Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9710385

FEI Number

3003138129

Entity Name

RINI ERGOTEKNIK AB

City/State/Country

Vallentuna Uppsala, SE

Establishment Address

Fagelsangsvagen 3B, Vallentuna Uppsala 18642, SE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Rini Ergoteknik AB (Owner Number: 9046622)

Owner / Operator Contact Address

Fagelsangsvagen 3B, --, Vallentuna, SE-AB 18642, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pedal Platform Carl Mk2 Without armrests Carl Mk3E R7 Carl Mk2 R7 Carl Spring R6 Carl Mk2 R5 Carl Mk2 R6 Carl 4 Foot R5 Carl 4 Heel R5 Carl Mk2 R8 Carl Swing R6 Carl Swing R7 Carl 4 Heel R6 Carl 4 Heel R7 Carl Spring R7 Carl 4 Foot R7 Carl Mk3 R7 Carl 4 Foot R6

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GBB	Chair, Surgical, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2026-03-18
HMD	Chair, Ophthalmic, Manual	Ophthalmic	Class 1	886.1140	2001-06-20

Official Correspondent

Lisa Jaderberg

US Agent Details

Albert Ludvigsen Email: al@surgicalone.com Phone: (586) 7753300

Related Public Records

Same Entity

Rini Ergoteknik AB

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3042971592	RESTAND MEDIC	Zur Yigal Central, IL
3043615368	HELLSTERN MEDICAL GMBH	Wannweil Baden-Wurttemberg, DE
3017937246	TAKARA BELMONT CORPORATION,SHIGA EQUIPMENT FACTORY	KONAN Shiga, JP
3005290141	KNU, LLC	Leland, MS, US
1724810	MEDICAL TECHNOLOGY INDUSTRIES, INC.	SALT LAKE CITY, UT, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710385. Last updated year: 2026. Please use registration number 9710385 when referencing this establishment in official correspondence.