Philips Wearable Biosensor

FDA UDI

Class II (US FDA UDI)

by Philips Medical Systems Hsg

Identity

Trade Name: Philips Wearable Biosensor FDA UDI
Generic Name: Kinesiology ambulatory recorder FDA UDI
Model / Reference: 989803196871 FDA UDI

Identifiers

Catalog Number: 989803196871 FDA UDI
Primary DI / UDI-DI: 20884838064960 FDA UDI
510(k) Number: K152139 FDA UDI
FDA Product Code: DRG FDA UDI
GMDN Term: Kinesiology ambulatory recorder FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2910 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Kinesiology ambulatory recorder

Philips Wearable Biosensor by Philips Medical Systems Hsg — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K152139 also covers:

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

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Manufacturer

Manufacturer: Philips Medical Systems Hsg

Sources (1)

FDA UDI fb66ca70-707a-4c1d-b27e-dc5bb2db1f89 35 fields · synced May 30, 2026