Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003175285

FEI Number

3003175285

Entity Name

MEDI-DYNE HEALTHCARE PRODUCTS, INC.

City/State/Country

COLLEYVILLE, TX, US

Establishment Address

1812 INDUSTRIAL BLVD., COLLEYVILLE, TX 76034, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

MEDI-DYNE HEALTHCARE PRODUCTS, LTD (Owner Number: 9054275)

Owner / Operator Contact Address

1812 INDUSTRIAL BLVD., --, Colleyville, TX 76034, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

2 Toms Foot Shield - TT240P 2Toms Blister Shield - TT003P & TT004 2 Toms Sport Shield XTRA - TT067P 2 Toms Grip Shield - TT210p 2 Toms Stink Free Detergent and Spray - TT400 & TT405 2 Toms Butt ShieldTT012p 2 Toms Sports Shield - TT005P Junior Plus - S02111 Knot Bad Gen 3 - S02302 Trio S02206 Pro Stretch Night Sock - S00071 Uno SO2108 Pro Roller - S02100 Hexi - SO2201 Type C - S02105 Mini Knot Bad 3 - S02305 Type X2 Plus - S02107 Footy - S02200 Peanut - Regular - S02204 Round Chucks - S02205 Nonagon - S02203 Type A Plus S02101 Marble Roller - S02112 TULI'S POLAR BEARS DUAL DENSITY HEEL CUPS - 10300 - 10310 TULI'S GEL CLASSIC HEEL CUPS - 10217 - 10219 Tuli's Cheetah Gen 2 - 20220 - 20240 Tuli's So Soft Insole - 10032 TULI'S GEL HEAVY DUTY HEEL CUPS - 10217-10219 TULI'S METATARSAL CUSHIONS - 10070 Tuli's XBRACE - XB940 - XB945 Tuli's So Soft Heel Cups - 10207 - 10208 TULI'S CLASSIC HEEL CUPS - 10211-10212 TULI'S 3/4 ARCH GAITORS - 10510 - 10540 Tuli's Plantar Faciitis Insole - 10091 - 10094 Tuli's XBRACE PLUS - XBRM941 - XBRM945 TULI"S X BRACE - XB940 - XB945 TULI'S Hammer RX - 10680 TULI'S ROADRUNNERS - 10410 - 10440 TULI'S PERSONAL FATIQUE MATS - 10080 TULI'S HEAVY DUTY HEEL CUPS - 10211 - 10214 TULI'S BALL OF FOOT PADS TULI'S CHEETAHS - 10221S - 10225S Tuli's Soft Moves Adjustable Toe Separators - SM00031 - SM00032 - SM00033 Trio S02206 Pro Roller - S02100 Junior Plus - S02111 Mini Knot Bad 3 - S02305 Type C - S02105 Round Chucks - S02205 Peanut - Regular - S02204 Footy - S02200 Uno SO2108 Hexi - SO2201 Pro Stretch - S00010 Pro Stretch Night Sock - S00071 Type A Plus S02101 Marble Roller - S02112 Nonagon - S02203 Type X2 Plus - S02107 Pro Stretch Plus - S01000 Knot Bad Gen 3 - S02302 Core Stretch - cs0001 Shoulder Flex - S04001 ProStretch Z TULI'S FOOT THERAPY WRAP - 10120

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NSB	Patient Personal Hygiene Kit	Dental	Class 1	872.6855	2014-06-06
LYG	Massager, Therapeutic, Manual	Physical Medicine	Class 1	890.5660	2025-04-09
KYS	Insoles, Medical	General Hospital	Class 1	880.6280	2013-03-05
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2013-03-08
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2022-06-29
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2025-12-03

Official Correspondent

Rod Swords

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MEDI-DYNE HEALTHCARE PRODUCTS, LTD

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 3003175285. Last updated year: 2026. Please use registration number 3003175285 when referencing this establishment in official correspondence.