Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1063312

FEI Number

3000719631

Entity Name

MEDI MFG., INC.

City/State/Country

WHITSETT, NC, US

Establishment Address

6481 FRANZ WARNER PKWY., WHITSETT, NC 27377, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

MEDI BAYREUTH (Owner Number: 8010822)

Owner / Operator Contact Address

MEDICUSSTR. 1, --, BAYREUTH, BAVARIA, DE-NOTA 95448, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Levamed stabili-tri Protect Leva strap Achimed CEP ortho plantar fasciitis sleeve protect.Ankle Lace-up, protect.Ankle Air Foam, protect.Ankle Foot Orthosis Levamed Protect Leva II CEP ortho ankle brace CEP ortho achilles brace medi elastic Ankle Support Levamed active CEP ortho ankle sleeve medi ankle sport brace medi protect.Air Walker Boot protect.Ankle Air Foam Protect.Walker Boot Protect.ROM Walker Boot TG Pro Taco Ankle protect.CAT Walker protect.CO TG Pro Taco Ankle 30% protect.ST protect.Achi protect.Seamless Knit Ankle Support TG Pro Taco Ankle 15% pro premium ankle brace protect.Leva Doc Ortho achi ankle support Doc Ortho ankle air foam one size Doc Ortho seamless knit ankle support Doc Ortho swift lace ankle support Doc Ortho leva ankle support Rejuva Mediven Active Cotton mediven Forte mediven Comfort Vitality Duomed Patriot mediven Harmony, mediven Harmony SL mediven Dual Layer Stocking System mediven Casino mediven For Men Select mediven Plus mediven Mondi Esprit Arm mediven Sheer & Soft mediven For Men Classic mediven Active mediven Comfort mediven Mondi mediven Thrombexin 18 mediven 550 leg Assure, Venasole, Reveal medi Butler mediven Esprit mediven 550 Arm Duomed Relax Duomed Advantage Duomed Freedom mediven Elegance mediven Angio mediven Struva 23, mediven Struva 35 mediven Cosy Brace Liner Duomed Soft Stripe Mediven Comfort Sculpt Leggings MEDI ACTIVE MEDI WRIST BANDAGE circaid compression anklet Compressive Undersock medi PT Control medi PTS CEP ortho knee sleeve Undersleeve Genumedi pro protect 4 evo Genumedi plus Collamed OA CEP ortho knee brace M.4s PCL dynamic Genumedi medi elastic knee support (601, 602, 603, 605) CEP T:25 Knee M.4s OA protect.Neoprene Knee Support protect.Seamless Knit Knee Support Genumedi PSS knee sl w/buttress & straps Stabimed protect.Genu Knee Support M.4s Comfort Genumedi PT knee wrap w/hinges & straps pro neoprene knee support protect.Genu Stabimed Pro 606 MEDI ACTIVE Genumedi pro ROM Genumedi E+motion medi knee immobilizer Doc Ortho genu knee support Doc Ortho essential knee brace Doc Ortho neoprene knee support Doc Ortho seamless knit knee support Doc Ortho neoprene knee stabilizer Doc Ortho CF hinged neoprene knee support Doc Ortho patella tracking brace Doc Ortho hinged neop knee brace MEDI KNEE BRACE MODEL #'S 601 circaid juxtafit circaid juxtacures (compression ulcer recovery system) circaid reduction kit circaid juxtalite circaid graduate circaid single band ankle foot wrap (afw) circaid customizable hand wrap circaid customizable interlocking ankle foot wrap circaid juxtalite HD circaid power added compression (pac) band restiffic relief circaid reduction kit vest Norton Hand Solution circaid reduction kit head & neck Doc Ortho relief medi pneumatic compression system (pcs) - genius (Model 652) STRUVA FIX medi pneumatic compression system (pcs) - brio (Model 651) AC Abduction Pillow Protect Arm Sling medi ArmSling Doc Ortho arm sling medi 4C flex Omomed Manumed active protect.SIS Rhizomed soft medi foot support medi elastic elbow support protect.Manu active tennis elbow strap Epibrace protect.Universal Wrist/Thumb Brace protect.Heel Spur Pro Footsupport protect.Universal Wrist Brace protect.Carpal Tunnel Support protect.Epi Elbow Support medi footsupport Natural insole protect.Control Footsupport Manumed Doc Ortho Foot Support Ballerinas Pro Doc Ortho Foot Support Junior Insole Doc Ortho Foot Support Business Pro Epicomed protect.strutz Pro protect.Seamless Elbow Support protect.Tennis Elbow Strap Doc Ortho Foot Support Active protect.Heel Spur Footsupport medi wrist brace protect.Comfort Footsupport Doc Ortho Foot Support Business Doc Ortho Foot Support Comfort Doc Ortho Foot Support Comfort Pro High Heel Foot Supports medi premium wrist brace Doc Ortho Foot Support Business Slim Pro SDP PF PRO-EURO footsupport protect.Epico Rom protect.Epi medi footsupport Heel Spur medi footsupport Natural Pro Doc Ortho Foot Support Control Manumed T medi footsupport Heel Spur Pro medi footsupport Control Slim Manumed RFX medi Humeral Fracture Brace Doc Ortho Foot Support Plantar Fasciitis Doc Ortho uni wrist thumb brace Doc Ortho premium wrist brace Doc Ortho Foot Support OA Pro Doc Ortho seamless knit elbow support Doc Ortho uni wrist brace Doc Ortho epi elbow support Doc Ortho Foot Support Plantar Fasciitis Pro Doc Ortho CF premium wrist brace Doc Ortho carpal tunnel support Doc Ortho Foot Support OA Wedge Doc Ortho tennis elbow strap Circaid Profile Circaid Reduction Kit Glove Circaid Reduction Kit Toe Cap comfort armsleeve

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	1986-04-22
DWL	Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)	General Hospital	Class 2	880.5780	2007-11-14
ISZ	Unit, Wrist, External Limb Component, Mechanical	Physical Medicine	Class 1	890.3420	1986-04-22
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2015-09-10
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	1986-04-22
MDR	Binder, Medical, Therapeutic	General Hospital	Class 1	880.5160	2012-10-19
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2022-09-20
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2006-03-14
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2019-06-17
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2018-03-02
IQF	Orthosis, Cervical-Thoracic, Rigid	Physical Medicine	Class 1	890.3490	1997-01-28
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2005-08-24
KMO	Binder, Elastic	General Hospital	Class 1	880.5160	2021-05-12
ILG	Stocking, Elastic	Physical Medicine	Class 1	890.3475	2019-08-01

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MEDI BAYREUTH

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
8010822	MEDI BAYREUTH	BAYREUTH, BAVARIA, DE

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1063312. Last updated year: 2026. Please use registration number 1063312 when referencing this establishment in official correspondence.