RS-4i Plus Sequential Stimulator Kit (R)

FDA UDI

Class II (US FDA UDI)

by Rs Medical

Identity

Trade Name: RS-4i Plus Sequential Stimulator Kit (R) FDA UDI
Generic Name: Interferential electrical stimulation system FDA UDI
Device Name: RS-4i Plus Sequential Stimulator with Intersperse, Refurbished. Kit includes RS-4i Plus Interferential Stimulator, treatment cable, rechargeable battery, battery charging dock, AC adapter, and treatment electrodes. FDA UDI
Model / Reference: 960-0100-00 FDA UDI
Description: RS-4i Plus Sequential Stimulator with Intersperse, Refurbished. Kit includes RS-4i Plus Interferential Stimulator, treatment cable, rechargeable battery, battery charging dock, AC adapter, and treatment electrodes. FDA UDI

Identifiers

Primary DI / UDI-DI: 00850814007043 FDA UDI
510(k) Number: K112348 FDA UDI
FDA Product Code: IPF FDA UDI
LHI FDA UDI
GMDN Term: Interferential electrical stimulation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.5850 FDA UDI
880.5440 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Physical therapy transcutaneous neuromuscular electrical stimulation system Interferential electrical stimulation system

RS-4i Plus Sequential Stimulator Kit (R) by Rs Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Interferential electrical stimulation system.

Hako-Med — HAKO-MED Herstellung + Vertrieb von medizinisch-technischen Geräten G.m.b.H. · Class II
VECTTOR Therapy System — ALAN NEUROMEDICAL TECHNOLOGIES, L.L.C. · Class II
VQ OrthoCare — Vision Quest Industries Incorporated · Class II
COMPEX — DJO, LLC · Class II
NexWave — ZYNEX MEDICAL, INC. · Class II
Hakomed — HAKOMED ASIA COMPANY LIMITED · Class II
COMPEX — DJO, LLC · Class II
MediMax Tech — MEDIMAX TECH INC. · Class II

Cleared under the same submission

K112348 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: Rs Medical

Sources (1)

FDA UDI 7e3d6beb-4ec6-4c43-8da2-634d103578f0 35 fields · synced May 31, 2026