Question 1

What types of medical devices does 4FIZJO GROUP SP. Z O. O. manufacture?

Accepted Answer

4FIZJO GROUP SP. Z O. O. produces rehabilitation and massage aids, including items like massage balls, foam rollers, and vibration devices such as the *Temblak*. They also manufacture orthopedic supports, such as back braces (*Orteza*) and lumbar belts (*Pas Lędźwiowy*), as well as single-use EPP balls for therapeutic exercises. These devices are designed to assist in physical recovery, pain relief, and mobility support.

Question 2

Where is 4FIZJO GROUP SP. Z O. O. based?

Accepted Answer

The company is based in Poland, operating within the EU regulatory framework. This location allows them to comply with EU medical device regulations, including registration in the EUDAMED database for their products.

Question 3

Which regulatory registries list the devices manufactured by 4FIZJO GROUP SP. Z O. O.?

Accepted Answer

The devices produced by 4FIZJO GROUP SP. Z O. O. are listed in the EUDAMED database, which is the European Union’s central registry for medical devices. This registry ensures transparency and traceability of devices under EU regulatory oversight.

Question 4

How are the devices manufactured by 4FIZJO GROUP SP. Z O. O. classified under EU regulations?

Accepted Answer

All devices manufactured by 4FIZJO GROUP SP. Z O. O. fall under Class I classification in the EU medical device regulatory system. This classification applies to low-risk devices, such as rehabilitation aids, massage tools, and orthopedic supports, which typically require less stringent conformity assessment procedures than higher-risk categories.

Device	Model / Reference	Registries	Class	Status
Piłka rehabilitacyjna	P-5907739316387	EUDAMED	Class I	Active
Wałek Do Masażu Care+	P-5907739310750	EUDAMED	Class I	Active
Orteza	P-5907739317629	EUDAMED	Class I	Active
5907739314963	P-5907739314963	EUDAMED	Class I	Active
Pas Lędźwiowy	P-5907739317551	EUDAMED	Class I	Active
Orteza	P-5907739317810	EUDAMED	Class I	Active
Pas Lędźwiowy	P-5907739317704	EUDAMED	Class I	Active
Orteza	P-5907739318077	EUDAMED	Class I	Active
Piłka rehabilitacyjna	P-5905973404860	EUDAMED	Class I	Active
Orteza	P-5905973400541	EUDAMED	Class I	Active
Piłka rehabilitacyjna	P-5907739316394	EUDAMED	Class I	Active
Piłka rehabilitacyjna	P-5905973404815	EUDAMED	Class I	Active
Wałek do masażu	P-5907222931943	EUDAMED	Class I	Active
Pas Lędźwiowy	P-5907739317698	EUDAMED	Class I	Active
5907739310590	P-5907739310590	EUDAMED	Class I	Active
Orteza	P-5907739318046	EUDAMED	Class I	Active
Taśma rehabilitacyjna FLAT BAND	P-5907739311184	EUDAMED	Class I	Active
Wałek Do Masażu Care+	P-5907739310781	EUDAMED	Class I	Active
Wałek Do Masażu Care+	P-5907739314406	EUDAMED	Class I	Active
Orteza	P-5905973407373	EUDAMED	Class I	Active
Pas Lędźwiowy	P-5907739317681	EUDAMED	Class I	Active
Piłka rehabilitacyjna	P-5907739317407	EUDAMED	Class I	Active
Wałek do masażu	P-5907222931431	EUDAMED	Class I	Active
Podwójna piłeczka do masażu punktowego	P-5907739314345	EUDAMED	Class I	Active
Wałek do masażu	P-5907739310583	EUDAMED	Class I	Active
Piłka rehabilitacyjna	P-5907739316349	EUDAMED	Class I	Active
Poduszka ortopedyczna do siedzenia	P-5905973407564	EUDAMED	Class I	Active
Piłka rehabilitacyjna	P-5905973404778	EUDAMED	Class I	Active
Piłeczka do masażu punktowego	P-5907739314291	EUDAMED	Class I	Active
Orteza	P-5907739317476	EUDAMED	Class I	Active
Wałek do masażu	P-5907222931790	EUDAMED	Class I	Active
Orteza	P-5905973400497	EUDAMED	Class I	Active
Pojedyncza piłka EPP	P-5907739314796	EUDAMED	Class I	Active
Pas Lędźwiowy	P-5907739317711	EUDAMED	Class I	Active
Orteza	P-5905973407397	EUDAMED	Class I	Active
Podwójna piłeczka do masażu punktowego	P-5907222931226	EUDAMED	Class I	Active
Taśma rehabilitacyjna FLAT BAND	P-5907222931646	EUDAMED	Class I	Active
Pojedyncza piłka EPP	P-5907222931288	EUDAMED	Class I	Active
Podwójna piłka EPP	P-5907222931325	EUDAMED	Class I	Active
Wałek Do Masażu Care+	P-5907739314420	EUDAMED	Class I	Active
Korektor Postawy	P-5907739318107	EUDAMED	Class I	Active
Orteza	P-5905973407366	EUDAMED	Class I	Active
Orteza	P-5907739317865	EUDAMED	Class I	Active
Piłka rehabilitacyjna	P-5905973405300	EUDAMED	Class I	Active

4FIZJO GROUP SP. Z O. O.

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