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-5905973403290	EUDAMED	Class I	Active
Wałek do masażu	P-5907222931141	EUDAMED	Class I	Active
Wałek do masażu	P-5907222931417	EUDAMED	Class I	Active
Temblak	P-5907739317513	EUDAMED	Class I	Active
Piłeczka do masażu punktowego	P-5907739314307	EUDAMED	Class I	Active
Orteza	P-5905973407403	EUDAMED	Class I	Active
Pojedyncza piłka EPP	P-5907222931233	EUDAMED	Class I	Active
Piłka rehabilitacyjna	P-5907739316271	EUDAMED	Class I	Active
Orteza	P-5907739318008	EUDAMED	Class I	Active
Pas Lędźwiowy	P-5907739318169	EUDAMED	Class I	Active
Pas Lędźwiowy	P-5907739317742	EUDAMED	Class I	Active
Piłka rehabilitacyjna	P-5905973405317	EUDAMED	Class I	Active
Poduszka ortopedyczna pod plecy	P-5905973407571	EUDAMED	Class I	Active
Orteza	P-5907739317506	EUDAMED	Class I	Active
Orteza	P-5907739317797	EUDAMED	Class I	Active
Poduszka ortopedyczna między nogi	P-5905973407557	EUDAMED	Class I	Active
Orteza	P-5907739317896	EUDAMED	Class I	Active
Piłka rehabilitacyjna	P-5905973404723	EUDAMED	Class I	Active
Orteza	P-5905973407359	EUDAMED	Class I	Active
Orteza	P-5907739317957	EUDAMED	Class I	Active
Piłka rehabilitacyjna	P-5907739316257	EUDAMED	Class I	Active
Orteza	P-5907739317636	EUDAMED	Class I	Active
Piłka rehabilitacyjna	P-5905973404792	EUDAMED	Class I	Active
Orteza	P-5905973407380	EUDAMED	Class I	Active
Orteza	P-5907739318152	EUDAMED	Class I	Active
Orteza	P-5907739317919	EUDAMED	Class I	Active
5907222931950	P-5907222931950	EUDAMED	Class I	Active
Orteza	P-5907739317872	EUDAMED	Class I	Active
Podwójna piłeczka do masażu punktowego	P-5907739314321	EUDAMED	Class I	Active
Orteza	P-5907739317827	EUDAMED	Class I	Active
Piłka rehabilitacyjna	P-5907739310538	EUDAMED	Class I	Active
Orteza	P-5907739317490	EUDAMED	Class I	Active
Orteza	P-5905973407281	EUDAMED	Class I	Active
Pas Lędźwiowy	P-5907739317735	EUDAMED	Class I	Active
Orteza	P-5905973407410	EUDAMED	Class I	Active
Pas Lędźwiowy	P-5907739317575	EUDAMED	Class I	Active
Piłka rehabilitacyjna	P-5907739314499	EUDAMED	Class I	Active
Orteza	P-5907739317520	EUDAMED	Class I	Active
Piłka rehabilitacyjna	P-5907739316356	EUDAMED	Class I	Active
Piłka rehabilitacyjna	P-5905973404846	EUDAMED	Class I	Active
Wałek Do Masażu Care+	P-5907739310743	EUDAMED	Class I	Active
Orteza	P-5905973407328	EUDAMED	Class I	Active
Pas Ciążowy	P-5907739317674	EUDAMED	Class I	Active
Orteza	P-5907739318039	EUDAMED	Class I	Active
Piłka rehabilitacyjna	P-5907739317384	EUDAMED	Class I	Active
Pas Ciążowy	P-5907739317650	EUDAMED	Class I	Active
Piłka rehabilitacyjna	P-5905973404853	EUDAMED	Class I	Active
Orteza	P-5907739318060	EUDAMED	Class I	Active
Orteza	P-5907739318022	EUDAMED	Class I	Active
Piłka rehabilitacyjna	P-5907739316387	EUDAMED	Class I	Active

4FIZJO GROUP SP. Z O. O.

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