Data / Medical devices / United States / Altimate Medical, Inc.

Altimate Medical, Inc.: FDA-registered device maker in Morton, MN, United States, 4 510(k) clearances

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

Altimate Medical, Inc. is registered with the FDA (registration 2183634) in Morton, MN, United States. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated August 13, 2013. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2183634
Address: 262 West First ST., Morton, MN, United States, 56270
Owner or operator: Altimate Medical, Inc. (10047568)
Roles: Manufacturer
First device listed: October 6, 2014
Registered through: 2026
Brand names listed: EasyStand, EasyStand Bantam, EasyStand Bantam Medium, EasyStand Evolv, EasyStand StrapStand, EasyStand Zing, EasyStand Zing Portable Size 1, EasyStand Zing Size 2

Devices it lists

Device	Product code	Class	Role	Source
Chair, Positioning, Electric	INO	2	Manufacturer	accessdata.fda.gov
Exerciser, Non-Measuring	ION	1	Manufacturer	accessdata.fda.gov
Table, Mechanical	INW	1	Manufacturer	accessdata.fda.gov
Table, Powered	INQ	1	Manufacturer	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
August 13, 2013	K123834	EASYSTAND BANTAM MEDIUM	INO	Substantially Equivalent	Altimate Medical, Inc.	accessdata.fda.gov
July 6, 2009	K091242	BANTAM	INO	Substantially Equivalent	Altimate Medical, Inc.	accessdata.fda.gov
September 21, 2006	K062402	EASYSTAND EVOLV	INO	Substantially Equivalent	Invacare Corp.	accessdata.fda.gov
May 1, 1989	K885343	STANDEX	ION	Substantially Equivalent	Alt, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
November 30, 2022	91335	Class II	Terminated	ActiveAid 922, Shower/Commode Chair	Device manufactured with a component with affects the foldability of the frame, not allowing it to be secured by the frame strap in the folded position.	accessdata.fda.gov
October 4, 2022	91002	Class II	Terminated	EasyStand Bantam, with the following sizes. a. Small; b. Extra Small. Used for assisting individual in standing.	Some EasyStand Bantam Small and Extra Small standers with the non-supine option may have been manufactured with a component that affects the operation of the leg assembly bracket to maintain the standers non-supine position.	accessdata.fda.gov

Compare with other makers

Updated January 4, 2023. 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.