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: Battery + Knee Wrap "Combo" FDA UDI
Model / Reference: SR-CMXK10HJ FDA UDI
Description: Battery + Knee Wrap "Combo" FDA UDI

Identifiers

Primary DI / UDI-DI: 00031262110534 FDA UDI
510(k) Number: K221862 FDA UDI
FDA Product Code: IRP FDA UDI
GMDN Term: Pneumatic massager FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.5650 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

Similar devices

Also classified as Pneumatic massager.

Compressible Limb Therapy System(LX7(V7)) — DAESUNG MAREF CO., LTD. · Class II
Compressible Limb Therapy System(MK300L) — DAESUNG MAREF CO., LTD. · Class II
Compressible Limb Therapy System(LX7(V7)) — DAESUNG MAREF CO., LTD. · Class II
Compressible Limb Therapy System — DAESUNG MAREF CO., LTD. · Class II
Compressible Limb Therapy System — DAESUNG MAREF CO., LTD. · Class II
medisana — ZHANGZHOU EASEPAL INNOVATION CO., LTD. · Class II
Homedics — Huizhou Xinyi Technology Co., Ltd. · Class II
Compressible Limb Therapy System — DAESUNG MAREF CO., LTD. · Class II

Cleared under the same submission

K221862 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

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

Manufacturer

Manufacturer: Fka Distributing Co., Llc

Sources (1)

FDA UDI 5cc42f7a-7aee-4e16-96f7-540fb83330f3 34 fields · synced Jun 8, 2026