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Body Weight Support (BWS) Light; Model No. RB011; a component of C-Mill, Grail, M-Gait - Product Usage: is designed to facilitate functional gait training of subjects with gait and/or balance impairment by providing dynamic partial vertical unloading during walking on a treadmill. The device will be used as an assistive device for gait deficiency rehabilitation and research purposes.

FDA Enforcement
Class II ·Ongoing·MOTEK MEDICAL B.V.·June 3, 2020

AFCS SANDS (SAT1) Control unit

Device
EU MDR · Eu Md Class 2b ·Synergie Nederland·On the market·1 country

AFCS SANDS (SAT1) Bed unit

Device
EU MDR · Eu Md Class 2b ·Synergie Nederland·On the market·1 country

AFCS PEARLS™ Bed Unit

Device
EU MDR · Eu Md Class 2b ·Synergie Nederland·On the market·1 country

NON-ACTIVE ANTI-DECUBITUS MEDICAL CUSHIONS

Device
EU MDR · Eu Md Class 1 ·Vicair B.V.·On the market·23 countries

DR,U,2PLY,300X200,SP10

Device
EU MDR · Eu Md Class 1 ·Medica Europe B.V.·On the market

AFCS PEARLS™ (SAT2) Control Unit

Device
EU MDR · Eu Md Class 2b ·Synergie Nederland·On the market·1 country

Untire Now

Device
EU MDR · Eu Md Class 1 ·Tired of Cancer BV·On the market

OTC Medical B.V.

Authorized representative
🇳🇱 Netherlands·1 Manufacturer

Untire Now

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Tired of Cancer BV·1 device

Sonoma Pharmaceuticals Netherlands B.V.

Importer
🇳🇱 Netherlands·1 Manufacturer

Comfortable Nederland BV

Manufacturer
🇳🇱 Netherlands

Twizzler BV

Manufacturer
🇳🇱 Netherlands

Maastricht Instruments

Manufacturer
🇳🇱 Netherlands

Resyca B.V.

Manufacturer
🇳🇱 Netherlands·1 Basic UDI-DI·2 Devices

Gynotec B.V.

Manufacturer
🇳🇱 Netherlands

4WEB EU B.V.

Manufacturer
🇳🇱 Netherlands

Polyganics Holding BV

Manufacturer
🇳🇱 Netherlands

INTELLIGO B.V.

Manufacturer
🇳🇱 Netherlands

PMT Partners Medische Techniek

Manufacturer
🇳🇱 Netherlands