Accelstim

FDA UDI

Class III (US FDA UDI)

by Igea Spa

Identity

Trade Name: Accelstim FDA UDI
Generic Name: Bone growth ultrasonic stimulator FDA UDI
Device Name: Replacement Ultrasound Gel, Accelstim 4300 FDA UDI
Model / Reference: UBHS-02 FDA UDI
Description: Replacement Ultrasound Gel, Accelstim 4300 FDA UDI

Identifiers

Catalog Number: 654300-9001 FDA UDI
Primary DI / UDI-DI: 08050040997299 FDA UDI
PMA Number: P210035 FDA UDI
FDA Product Code: LOF FDA UDI
GMDN Term: Bone growth ultrasonic stimulator FDA UDI

Classification

Device Class: Class III 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

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Bone growth ultrasonic stimulator

Accelstim by Igea Spa — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone growth ultrasonic stimulator.

AccelStim — Orthofix US LLC · Class II
AccelStim — Orthofix US LLC · Class III
EXOGEN® Ultrasound Bone Healing System — BIOVENTUS LLC · Class II
EXOGEN® Ultrasound Bone Healing System — BIOVENTUS LLC · Class III
EXOGEN® Ultrasound Bone Healing System — BIOVENTUS LLC · Class III
EXOGEN® Ultrasound Bone Healing System MOU — BIOVENTUS LLC · Class III
AccelStim — Orthofix US LLC · Class III
Accelstim — IGEA SPA · Class III

Cleared under the same submission

P210035 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 III	Pending data

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Manufacturer

Manufacturer: Igea Spa

Sources (1)

FDA UDI dc93e8ed-0421-45ae-b130-72b561517b40 35 fields · synced May 30, 2026