Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681527

FEI Number

3003105930

Entity Name

PINEL MEDICAL, INC.

City/State/Country

KITCHENER Ontario, CA

Establishment Address

236 RIVER BIRCH ST, KITCHENER Ontario N2C2V4, CA

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

PINEL MEDICAL, INC. (Owner Number: 9024546)

Owner / Operator Contact Address

236 RIVER BIRCH ST., --, KITCHENER, CA-ON N2C2V4, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PINEL TORSO CONTROL BELT PINEL WAIST BELT WITH PELVIC PINEL MAGNETIC LOCKING SYSTEM PINEL DE-RESTRAINT SYSTEM PINEL EMERGENCY KIT IN BAG PINEL COMPLETE KIT IN BAG PINEL UNIVERSAL LIMBS PINEL SHOULDER BELT PINEL BUTTERFLY CUFF

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2014-12-01

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

PINEL MEDICAL, INC.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K962327	Sekure Seat Corp.	SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE	1997-03-06
K963243	Heelbo, Inc.	HEELBO BLAZER SLEEVED JACKET	1996-10-01

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681527. Last updated year: 2026. Please use registration number 9681527 when referencing this establishment in official correspondence.