Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011336784

FEI Number

3011336784

Entity Name

NINOMED LLC

City/State/Country

Chapel Hill, NC, US

Establishment Address

241 Parker Rd, Chapel Hill, NC 27517, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Ninomed LLC (Owner Number: 10049397)

Owner / Operator Contact Address

241 Parker Rd, Chapel Hill, NC 27517, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Multi-Ring Head Positioner Slotted Foam Head Positioner Armboard Pad Chest Roll Small Ring Head Positioner Stirrup Strap without Slip Ring Stirrup Strap with Slip Ring Adult Head Positioner Heel Protector - Foam with Hook and Loop Strap Adult Ring Head Positioner Arm Cradles Positioning Body Straps - Blue Positioning Body Straps - White Ulnar Nerve Protector Cush-In It IV Wraps OR Table Pad Large Foam Body Wedge Safe-T-Secure® All-In-One Patient Stabilizer PLUMA-SOFT STS-Flex STS-BodyPad STS-Head-To-Toe STS-Flex-Extend

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2025-04-24
LWG	Surgical Table Cushion	General, Plastic Surgery	Class 1	878.4950	2015-05-26

Official Correspondent

Terence Mannion

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Ninomed LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011336784. Last updated year: 2026. Please use registration number 3011336784 when referencing this establishment in official correspondence.