← Back to catalogue

Relaxatio

FDA UDI

Class II (US FDA UDI)

by Omm Imports Inc.

Identity

Trade Name
Relaxatio FDA UDI
Generic Name
Musculoskeletal infrared phototherapy unit, non-wearable FDA UDI
Device Name
Over the counter Red/IR LED Heating device for minor aches and pains, temporary increase in circulation. FDA UDI
Model / Reference
RX100 FDA UDI
Description
Over the counter Red/IR LED Heating device for minor aches and pains, temporary increase in circulation. FDA UDI

Identifiers

Primary DI / UDI-DI
00850001456357 FDA UDI
FDA Product Code
ILY FDA UDI
GMDN Term
Musculoskeletal infrared phototherapy unit, non-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

Yes

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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Musculoskeletal infrared phototherapy unit, non-wearable

Relaxatio by Omm Imports Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Musculoskeletal infrared phototherapy unit, non-wearable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Omm Imports Inc.

Sources (1)

  • FDA UDI 9f9df58f-8920-44f5-bfc3-1e28480f6d0d 34 fields · synced May 31, 2026