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Fremslife

FDA UDI

Class II (US FDA UDI)

by Fremslife Srl

Identity

Trade Name
FREMSLIFE FDA UDI
Generic Name
Diagnostic peripheral nerve electrical stimulation system FDA UDI
Model / Reference
APTIVA 4 FDA UDI

Identifiers

Catalog Number
905-000-004 FDA UDI
Primary DI / UDI-DI
08055765540003 FDA UDI
510(k) Number
K061828 FDA UDI
FDA Product Code
GZJ FDA UDI
HCC FDA UDI
JXE FDA UDI
IKN FDA UDI
GMDN Term
Diagnostic peripheral nerve electrical stimulation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5890 FDA UDI
882.5050 FDA UDI
882.1550 FDA UDI
890.1375 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Diagnostic peripheral nerve electrical stimulation system

Fremslife by Fremslife Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Diagnostic peripheral nerve electrical stimulation system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fremslife Srl

Sources (1)

  • FDA UDI a90fcfcd-7d7e-48a4-9553-a11766e5edde 34 fields · synced May 30, 2026