BrainScope One International Charging Kit

FDA UDI

Class II (US FDA UDI)

by Brainscope

Identity

Trade Name: BrainScope One International Charging Kit FDA UDI
Generic Name: Noninvasive device battery charger FDA UDI
Model / Reference: 99-1403-028 FDA UDI

Identifiers

Primary DI / UDI-DI: 00852745007093 FDA UDI
510(k) Number: K161068 FDA UDI
FDA Product Code: OLU FDA UDI
PKQ FDA UDI
PIW FDA UDI
GMDN Term: Noninvasive device battery charger FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1400 FDA UDI
882.1470 FDA UDI
882.1450 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Noninvasive device battery charger

BrainScope One International Charging Kit by Brainscope — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Noninvasive device battery charger.

STARKEY HEARING TECHNOLOGIES — Starkey Laboratories Inc. · Class II
GN Hearing — Gn Hearing A/S · Class II
CONNEXX — WS Audiology USA, Inc. · Class II
Unitron Brand — Sonova AG · Class II
Beltone — Gn Hearing A/S · Class II
GN Hearing — Gn Hearing A/S · Class II
Docking Station — Medela LLC · Class II
GN Hearing — Gn Hearing A/S · Class II

Cleared under the same submission

K161068 also covers:

Ahead 300 — BRAINSCOPE
Ahead 300 International Charging Kit — BRAINSCOPE
Ahead Electrode Headset — BRAINSCOPE
Baseline Headset — BRAINSCOPE
Electrode Headset — BRAINSCOPE

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Brainscope

Sources (1)

FDA UDI 7f9cf6d6-125a-4db5-887d-a238e56fbbca 34 fields · synced Jun 6, 2026