What is FDA product code QTC?

An adult portable bed rail is a device intended for medical purposes to assist a patient to perform a specific function, including but not limited to assisting impaired individuals (e.g., disabled, injured, or those post-surgery or hospitalized) with transfer in and out of bed, and repositioning, to reduce risk of falling or fracture. This device may mitigate the risk of falling due to the effects of balance disorders or other medical conditions. This does not include guardrails or side rails intended for use on FDA regulated hospital beds and does not include portable bed rails used for pediatrics.

Physical Medicine › TherapeuticAdult Portable Bed Rails For Medical Purposes

Sterex

Name: Sterex
Brand: Sterex

Catalogue number HOFFSHR, listed by Jiangmen Elite Medical Equipment Ltd, China, under Adult Portable Bed Rails For Medical Purposes. 40 manufacturers in China are registered for this product code.

Registry build 21.09.26

40manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Guangdong (25), Jiangsu (6), Anhui (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code QTC
Manufacturer	City	Province	Registered as	Device types
Raise Medical Industries, Inc.	Foshan	Guangdong	Contract manufacturer	16
Nantong Shunlong Physical Therapy Equipment Co., Ltd.	Rugao	Jiangsu	Contract manufacturer	6
Guangzhou Four E’s Scientific Co., Ltd.	Guangzhou	Guangdong	Contract manufacturer	61
Yearstar Healthcare Technology Co., Ltd.	Jiangyin	Jiangsu	Contract manufacturer	43
Anhui Yibao Home Textile Co., Ltd.	Hefei	Anhui	Manufacturer	31
Zhongshan Saxin Electric Heating Technology Co., Ltd.	Zhongshan	Guangdong	Manufacturer	27
Mobility Source Medical Technology Co., Ltd.	Foshan	Guangdong	Contract manufacturer	26
Guangdong Shunde LQX Health Technology Inc.	Foshan	Guangdong	Contract manufacturer	24
Foshan Zubon Technology Co., Ltd.	Foshan	Guangdong	Manufacturer	23
Jiangyin Huashi Medical Equipment Co., Ltd.	Jiangyin	Jiangsu	Contract manufacturer	21
Guangzhou Baoli Hardware & Electronic Co., Ltd.	Guangzhou	Guangdong	Contract manufacturer	20
Bliss Health Products Co., Ltd.	Zhongshan	Guangdong	Contract manufacturer	19

Showing 12 of 40. All 40 manufacturers in China registered for Adult Portable Bed Rails For Medical Purposes

Record

Regulatory record for Sterex
Listed by	Jiangmen Elite Medical Equipment Ltd, China
FDA product code	QTC
Device type	Adult Portable Bed Rails For Medical Purposes
Device class	Class 1
Regulation	21 CFR 890.5050
Establishment	Manufacturer
Premarket notification	Exempt
Record published	2025-06-17

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	manufacturing date, serial number
Distribution end date	2025-06-24

Catalogue Numbers

Catalogue numbers for Sterex
Catalogue number	Size	Status
HOFFSHR		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Bed Rails for Elderly Adults	Zhongshan Yungu Daily Products Co., Ltd.	16
Costcare	Fujian Pacific Medical Manufacturing Co., Ltd.	9
GeriGentleEQ	Jiangmen Elite Medical Equipment Ltd	3
Dalton	Fujian Pacific Medical Manufacturing Co., Ltd.	2
AireMed	Jiangmen Elite Medical Equipment Ltd	2
Bios Living	Thermor Ltd.	1
ProBasics	Drive DeVilbiss Healthcare	1
Medline	Medline Industries, Inc.	1
Gendron	GF Health Products, Inc	1

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.