Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011767724

FEI Number

3011767724

Entity Name

MANAMED LLC

City/State/Country

Denton, TX, US

Establishment Address

2612 Sirius Drive, Denton, TX 76208, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

ManaMed LLC (Owner Number: 10049811)

Owner / Operator Contact Address

2612 Sirius Drive, Denton, TX 76208, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Belly Band ManaEZ Crutch Spring ManaEZ sling Universal ManaGo 71

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2022-06-15
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2015-08-03
IPT	Orthosis, Thoracic	Physical Medicine	Class 1	890.3490	2025-12-23
IPR	Crutch	Physical Medicine	Class 1	890.3150	2022-06-15
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2025-12-23
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2025-12-23
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2023-09-28
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2021-07-19
PFW	Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat	Physical Medicine	Class 2	890.5300	2023-08-17
IMI	Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat	Physical Medicine	Class 2	890.5300	2023-08-17
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2019-03-07
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2026-05-21
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2022-06-15
MUI	Media, Coupling, Ultrasound	Radiology	Class 2	892.1570	2023-08-17
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2020-10-13
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2024-01-31
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2022-06-15
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2025-12-23
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	2022-06-15

Official Correspondent

Trevor Theriot

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ManaMed LLC

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K170216	Tactile Systems Technology, Inc. (Dba Tactile Medical)	Flexitouch System	2017-05-26
K100306	Covidien	KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES	2010-05-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

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3012408006	INNOVANCE TEXTILES LIMITED	HONG KONG, HK
3031606416	ORTHOTECH REHABILITATION CO., LTD.	Xiamen Fujian, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011767724. Last updated year: 2026. Please use registration number 3011767724 when referencing this establishment in official correspondence.