Data / Medical devices / United States / Otto Bock Healthcare LP

Otto Bock Healthcare LP: FDA-registered device maker in Salt Lake City, UT, United States, 2 510(k) clearances

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

Otto Bock Healthcare LP is registered with the FDA (registration 1721652) in Salt Lake City, UT, United States. It lists 13 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 9, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1721652
Address: 3820 West Great Lakes Drive, Salt Lake City, UT, United States, 84120
Owner or operator: Ottobock SE & Co. KGaA (8010097)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed: December 29, 2004
Registered through: 2026
Brand names listed: AK Adapt Liner, AK Prosthetic Shrinker, Achillo Sensa, Acro ComforT, Active Contour Ankle Joint, Adjust, AeroLink Hybrid Liner, Ankle Foot Orthosis and more

Devices it lists

Device	Product code	Class	Role	Source
Assembly, Knee/Shank/Ankle/Foot, External	ISW	2	Manufacturer	accessdata.fda.gov
Component, External, Limb, Ankle/Foot	ISH	1	Manufacturer, Specification developer	accessdata.fda.gov
Cover, Limb	IPM	1	Manufacturer	accessdata.fda.gov
Joint, Ankle, External Brace	ITW	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Orthosis, Cervical	IQK	1	Specification developer	accessdata.fda.gov
Orthosis, Cervical-Thoracic, Rigid	IQF	1	Specification developer	accessdata.fda.gov
Orthosis, Cranial	MVA	2	Manufacturer	accessdata.fda.gov
Orthosis, Cranial, Laser Scan	OAN	2	Manufacturer	accessdata.fda.gov
Orthosis, Limb Brace	IQI	1	Contract manufacturer, Manufacturer, Specification developer	accessdata.fda.gov
Orthosis, Lumbar	IQE	1	Specification developer	accessdata.fda.gov
Orthosis, Lumbo-Sacral	IPY	1	Specification developer	accessdata.fda.gov
Orthosis, Thoracic	IPT	1	Specification developer	accessdata.fda.gov
Prosthesis, Thigh Socket, External Component	ISS	1	Contract manufacturer, Specification developer	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
June 9, 2022	K213587	MyCRO Band	MVA	Substantially Equivalent	Otto Bock Healthcare LP	accessdata.fda.gov
March 26, 2021	K201426	MyCRO Band	MVA	Substantially Equivalent	Otto Bock Healthcare LP	accessdata.fda.gov

Compare with other makers

Updated June 9, 2022. 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.