Homedics

FDA UDI

Class II (US FDA UDI)

by Fka Distributing Co., Llc

Identity

Trade Name: Homedics FDA UDI
Generic Name: Pneumatic massager FDA UDI
Device Name: Modulair compression system calf wrap+controller bundle FDA UDI
Model / Reference: SR-CMXC5SHJ-BK FDA UDI
Description: Modulair compression system calf wrap+controller bundle FDA UDI

Identifiers

Primary DI / UDI-DI: 00031262115379 FDA UDI
FDA Product Code: IRP FDA UDI
IRT FDA UDI
GMDN Term: Pneumatic massager FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.5650 FDA UDI
890.5740 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

FDA UDI

Over-the-Counter

Yes

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

FDA UDI

Manufacturing Date

FDA UDI

Category: Pneumatic massager

Homedics by Fka Distributing Co., Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Fka Distributing Co., Llc

Sources (1)

FDA UDI bbe5d2b3-507b-4951-ab9f-6bd82f3ba4b6 33 fields · synced Jun 8, 2026