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NeoControl

FDA UDI

Class II (US FDA UDI)

by Magic Race Llc

Identity

Trade Name
NeoControl FDA UDI
Generic Name
Physical therapy transcutaneous electrical stimulation system, line-powered FDA UDI
Device Name
Control Unit, 110 volt, NeoControl Pelvic Floor Therapy System FDA UDI
Model / Reference
N-0228-G-110VAC FDA UDI
Description
Control Unit, 110 volt, NeoControl Pelvic Floor Therapy System FDA UDI

Identifiers

Primary DI / UDI-DI
00864618000315 FDA UDI
FDA Product Code
KPI FDA UDI
GMDN Term
Physical therapy transcutaneous electrical stimulation system, line-powered FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5320 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Physical therapy transcutaneous electrical stimulation system, line-powered

NeoControl by Magic Race Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Physical therapy transcutaneous electrical stimulation system, line-powered.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Magic Race Llc

Sources (1)

  • FDA UDI b6e60f6b-ee85-4f9f-9735-22eea57160ef 34 fields · synced Jun 8, 2026