Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2183520

FEI Number

2183520

Entity Name

Tenacious Holdings Inc

City/State/Country

Saint Paul, MN, US

Establishment Address

1021 Bandana Boulevard, Suite 220, Saint Paul, MN 55108, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

TENACIOUS HOLDINGS, INC. (Owner Number: 2183520)

Owner / Operator Contact Address

1021 Bandana Boulevard East, Suite 220, Saint Paul, MN 55108, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ergodyne Ergodyne Ergodyne Ergodyne Ergodyne

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2022-12-28
IMA	Pack, Heat, Moist	Physical Medicine	Class 1	890.5730	2022-12-28
ILG	Stocking, Elastic	Physical Medicine	Class 1	890.3475	2022-12-28
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	1994-09-20
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2022-12-28

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TENACIOUS HOLDINGS, INC.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2183520. Last updated year: 2026. Please use registration number 2183520 when referencing this establishment in official correspondence.