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Tommie copper

FDA UDI

Class II (US FDA UDI)

by Shenzhen Kaiyan Medical Equipment Co, . Ltd

Identity

Trade Name
Tommie copper FDA UDI
Generic Name
Musculoskeletal infrared phototherapy unit, wearable FDA UDI
Device Name
Tommie copper Infrared &Red light contour therapy wrap FDA UDI
Model / Reference
5008LD FDA UDI
Description
Tommie copper Infrared &Red light contour therapy wrap FDA UDI

Identifiers

Primary DI / UDI-DI
00843041136433 FDA UDI
FDA Product Code
ILY FDA UDI
GMDN Term
Musculoskeletal infrared phototherapy unit, wearable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5500 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

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Musculoskeletal infrared phototherapy unit, wearable

Tommie copper by Shenzhen Kaiyan Medical Equipment Co, . Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Musculoskeletal infrared phototherapy unit, wearable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shenzhen Kaiyan Medical Equipment Co, . Ltd

Sources (1)

  • FDA UDI 5e9ded14-ced5-451d-81bd-75f44127684d 34 fields · synced May 30, 2026