Data / Medical devices / United States / Normed

Normed: FDA-registered device maker in Seattle, WA, United States, 4 510(k) clearances

Name: Normed FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Normed is registered with the FDA (registration 3013226) in Seattle, WA, United States. It lists 28 device types. The FDA files 4 510(k) clearances under its listings, the newest dated November 17, 2017. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3013226
Address: 4320 SOUTH 131ST PL. Suite 160, Seattle, WA, United States, 98168
Owner or operator: NORMED (3013226)
Roles: Repackager or relabeler
First device listed: June 10, 1986
Registered through: 2026
Brand names listed: BACKPRO, BURN GEL, COLD PACK, CPR MASK, FORCEPS, HANDLE, MICROSHIELD, OXYGEN MASK and more

Devices it lists

Device	Product code	Class	Role	Source
Bandage, Elastic	FQM	1	Repackager or relabeler	accessdata.fda.gov
Bedding, Disposable, Medical	KME	1	Repackager or relabeler	accessdata.fda.gov
Cannula, Nasal, Oxygen	CAT	1	Repackager or relabeler	accessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or Biologic	NAE	1	Repackager or relabeler	accessdata.fda.gov
Forceps, General & Plastic Surgery	GEN	1	Repackager or relabeler	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Repackager or relabeler	accessdata.fda.gov
Handle, Scalpel	GDZ	1	Repackager or relabeler	accessdata.fda.gov
Joint, Ankle, External Brace	ITW	1	Repackager or relabeler	accessdata.fda.gov
Mask, Oxygen	BYG	1	Repackager or relabeler	accessdata.fda.gov
Mouthpiece, Breathing	BYP	1	Repackager or relabeler	accessdata.fda.gov
Orthosis, Limb Brace	IQI	1	Repackager or relabeler	accessdata.fda.gov
Orthosis, Lumbo-Sacral	IPY	1	Repackager or relabeler	accessdata.fda.gov
Pack, Hot Or Cold, Disposable	IMD	1	Repackager or relabeler	accessdata.fda.gov
Pack, Hot Or Cold, Reusable	IME	1	Repackager or relabeler	accessdata.fda.gov
Ring Cutter	FNS	1	Repackager or relabeler	accessdata.fda.gov
Scalpel, One-Piece	GDX	1	Repackager or relabeler	accessdata.fda.gov
Scissors, General, Surgical	LRW	1	Repackager or relabeler	accessdata.fda.gov
Scissors, Orthopedic, Surgical	HRR	1	Repackager or relabeler	accessdata.fda.gov
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	FMK	2	Repackager or relabeler	accessdata.fda.gov
Sling, Arm	ILI	1	Repackager or relabeler	accessdata.fda.gov
Splint, Extremity, Inflatable, External	FZF	1	Repackager or relabeler	accessdata.fda.gov
Splint, Extremity, Non-Inflatable, External, Non-Sterile	NOC	1	Repackager or relabeler	accessdata.fda.gov
Splint, Hand, And Components	ILH	1	Repackager or relabeler	accessdata.fda.gov
Support, Arm	IOY	1	Repackager or relabeler	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Repackager or relabeler	accessdata.fda.gov
Tourniquet, Nonpneumatic	GAX	1	Repackager or relabeler	accessdata.fda.gov
Tube, Aspirating, Flexible, Connecting	BYY	2	Repackager or relabeler	accessdata.fda.gov
Valve, Non-Rebreathing	CBP	2	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 17, 2017	K171961	Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)	CBP	Substantially Equivalent	Xiamen Compower Medical Tech. Co., Ltd.	accessdata.fda.gov
July 22, 2010	K083418	CPR MASK	CBP	Substantially Equivalent	Firstar Healthcare Co., Ltd.	accessdata.fda.gov
August 26, 2008	K081516	MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT	CBP	Substantially Equivalent	Medsource International, LLC	accessdata.fda.gov
December 22, 2005	K052743	DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921	CBP	Substantially Equivalent	Dynarex Corp.	accessdata.fda.gov

Compare with other makers

Updated November 17, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.