Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9612388

FEI Number

3003255844

Entity Name

BSN Medical S.A. de C.V.

City/State/Country

Reynosa Tamaulipas, MX

Establishment Address

Av. del Parque SN Villa Florida, Reynosa Tamaulipas 88715, MX

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

BSN medical GmbH (Owner Number: 9047426)

Owner / Operator Contact Address

Schutzenstrasse 1-3, Hamburg, DE-HH 22761, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K951234

PMA Number

N/A

All Registered Proprietary Names

ICE-08-01 Reusable Ice Bag for Ankle Orthosis ICE-04-01 - Reusable Ice Bag for Knee Orthosis GP-KN-01 - Knee Orthosis Reusable Cold Pack PowerPlay - GP-360-01 Gel Pack for PPKN-360 Knee Wrap BSN Hot-Cold Pack ICE-05-01 - Reusable Ice Bag for Shoulder Orthosis GP-AN-01 - Ankle Orthosis Reusable Gel Pack GP-SH-01 - Shoulder Orthosis Reusable Cold Pack GP-AN-01T - Ankle Orthosis Resuable Gel Pack (Tongue Accessory) Actimove Professional Line Rib Belt Two-Panel, For Women Actimove Professional Line Rib Belt Two-Panel, For Men DELTA DRY Softliner Delta Terry-Net Adhesive Felt Liner Delta-Rol Synthetic Padding Jersey Stockinette Delta-Lite Conformable Delta-Cast Elite Gelocast Elastic Specialist Splint Soffban Padding CAST BANDAGES (MULTIPLE BRANDS) Specialist 100 Cotton Padding SafetySplint Delta-Lite Plus Gypsona HP POP FlashCast Elite Orthoflex Elastic POP Gelostretch CAST (MULTIPLE BRANDS) Delta Terry-Net Loop Closures Delta-Cast Conformable Delta-Cast Soft ELASTOMULL Delta-Net Stockinette Gypsona Terry-Net S Stockinette OCL splint Roll DELTA DRY Stockinette Sof-Rol Synthetic Padding Ortho-Glass OCL POP CAST PADDING (MULTIPLE BRANDS) FlashCast Fiberglass Cast Tape Specialist Stockinette Delta Terry-Net Fleece Edger DELTA DRY Dynacast Prelude Specialist Cotton Blend Padding Ortho-Form Jersey Cotton Stockinette Terry-Net Thumb Spica Stockinette Specialist POP Terry-Net C Stockinette Delta-Cast Prints FlashCast Plaster of Paris Delta Terry-Net Padding Dynacast Ankle Splint Delta Dry Pantaloon Delta-Dry Padding Gypsona S POP Gelocast Specialist 100 Cotton Padding Sterile Dynacast Ankle Splint Kit Specialist Cotton Blend Padding Sterile Sof-Rol Synthetic Padding Sterile Delta-Rol Synthetic Padding Sterile Aquacast Liner Hipster Pantaloon Liner Isoband Tricofix Dynacast S Artiflex Actimove Professional Line Abdominal Binder Three-Panel Actimove Professional Line Abdominal Binder Comfort Soft Pad Actimove Professional Line Abdominal Binder Four-Panel ACTIMOVE SOLEA Actimove Everyday Supports Knee Support Open Patella, 4 Stays Actimove Sports Edition Patella Strap Adjustable Actimove Sports Edition Knee Brace Wrap Around Simple Hinges Condyle Pads Actimove Sports Edition Knee Support Open Patella, Adjustable Actimove Professional Line Genu Eco Knee Immobilizer Actimove Sports Edition Knee Brace Adjustable Horseshoe Simple Hinges Condyle Pads Actimove Everyday Supports Mild Knee Support Actimove Arthritis Care Knee Support Actimove Kids Knee Support Open Patella Actimove Sports Edition Knee Support Open Patella Actimove Everyday Supports Knee Support Closed Patella, 2 Stays Actimove Professional Line Genu Tri-Panel Knee Immobilizer Actimove Sports Edition Knee Brace Wrap Around Polycentric Hinges Condyle Pads Actimove Everyday Supports Knee Support Closed Patella Actimove Professional Line GenuMotion Knee Support Actimove Sports Edition Knee Support Closed Patella Actimove Sports Edition Dual Knee Strap Adjustable Actimove Sports Edition Knee Stabilizer Adjustable Horseshoe and Stays Actimove Sports Edition PF Knee Brace Lateral Support J-Shaped Buttress Simple Hinges, Condyle Pads Actimove Professional Line Genu Clips Actimove Professional Line Knee Brace, Composite Polycentric Hinges Actimove Professional Line HealWell Cub Plantar Fasciitis Night Splint Resting Comfort Slipper Actimove Professional Line Genu Eco/Genu Clips Extension Tab Actimove Professional Line Knee Immobilizer Tri-Panel ACTIMOVE POST-OP ROM KNEE BRACE Jobst Comprifore #3 LF Elastomull Jobst Comprilan Jobst Comprifore #1 Jobst Compri2 Tensoshape Tensogrip Co-Plus LF by Actimove Jobst Comprifore Lite LF , Jobst Comprifore #2 Jobst Comprifore #4 LF Jobst Comprifore LF Jobst Compri2 Lite JOBST MATERNITY SUPPORT BELT Actimove Professional Line Rhizo Forte Thumb Orthosis Actimove Professional Line Manus Forte Wrist Brace Actimove Sports Edition Wrist Stabilizer epimotion Metal Stay Left or Right Actimove Professional Line Gauntlet Wrist and Thumb Stabilizer Actimove Alufoam Actimove Arthritis Care Arthritis Gloves ACTIMOVE PROFESSIONAL LINE MANUS, WRIST STABILIZER Actimove Everyday Supports Wrist Stabilizer Carpal Pre-shaped Metal Stay Actimove Arthritis Care Wrist Support ACTIMOVE KIDS WRIST STABILIZER, REMOVABLE METAL STAY, LEFT OR RIGHT Actimove Sports Edition Thumb Stabilizer Extra Stays Actimove Sports Edition Wrist Support Adjustable Actimove Professional Line Manus Forte Plus Wrist & Thumb Brace Actimove Professional Line Manus Air Stabilizing Fracture Wrist Brace Actimove Sports Edition Wrist Support Elastic Wrap Around Actimove Professional Line Wrist Brace Suede Finish, Lace-Closure Actimove Professional Line Wrist Splint 6" Actimove Professional Line Wrist Splint, Abducted Thumb, Compression-Formed Composite Actimove Professional Line Wrist Splint 8" Actimove Professional Line ManuMotion Wrist Support Actimove Professional Line Thumb Spica Soft Fit Thumb and Wrist Brace Actimove Professional Line Manus Wrist Stabilizer Delta Thermo Orthoplast Boot Delta Thermo Memory Delta Thermo Thumb Delta Thermo Knee Delta Thermo Orthoplast Corset Delta Thermo Wrist Delta Thermo Elbow Delta Thermo Hand/Wrist Delta-Xpress Wrist Delta-Xpress Hand Delta-Xpress Elbow Delta-Xpress Lower Leg Actimove Everyday Supports Back Support High-Density Foam Panel Adjustable Double Layer Compression Actimove Sports Edition Back Support, 4 Stays, Adjustable Double Layer Compression Safe-T-Lift DX Actimove Sports Edition Back Stabilizer Rigid Panel with Pressure Pads SMART Easy-Closing-Pulley-System Safe-T-Belt Working Lumbar Belt Actimove Professional Line LO-PLUS Lumbar Support, Stabilizing Posterior Panel Actimove Professional Line LumbaMotion Back Support with Pressure Pad Actimove Professional Line LumbaMotion Lady Back Support with Pressure Pad Actimove Vertebrace Cervical Collar Actimove Professional Line Cervical Comfort Comfort Cervical Collar Actimove Kids Cervical Cervical Collar Actimove Professional Line Lumbar Sacral Support Actimove Professional Line Lumbar Sacral Support Comfort Additional Support Belt, Pressure Pad Actimove Professional Line Deluxe Lumbar Sacral Support Rigid Panel, for Women Actimove Professional Line Lumbar Sacral Support Comfort Additional Support Belt Actimove Everyday Supports Lumbar Sacral Support Actimove Kids Mitella Arm Sling Actimove Professional Line Sling Comfort Arm Sling - Dispenser Box Actimove Professional Line Umerus Shoulder Immobilizer Actimove Professional Line Mitella Comfort Comfort Arm Sling Actimove Professional Line Sling and Swathe Shoulder Immobilizer Actimove Professional Line Shoulder Abduction Sling Shoulder Immobilizer Actimove Professional Line Y-Tab for Sling Comfort Actimove Professional Line Umerus Comfort Comfort Shoulder Immobilizer Actimove Profesional Line Arm Sling Actimove Professional Line Sling Comfort Arm Sling Single Pack Actimove Professional Line Sling Arm Sling - On a Roll Actimove Professional Line Mitella Arm Sling JOBST BELLA STRONG GAUNTLET JOBST Armsleeves JOBST BELLA LITE GAUNTLET JOBST BELLA LITE ARMSLEEVE JOBST BELLA STRONG ARMSLEEVE JOBST BELLA LITE COMBINED PowerPlay - PPSH-59 Universal Shoulder Orthosis PowerPlay - PPWR-68U Universal Wrist Orthosis PowerPlay - PPEL-22 Universal Elbow Orthosis PowerPlay - PPBB-SBP Cold and Compression Back Wrap with One Gel Pack Actimove Professional Line PowerMotion Calf support Actimove Sports Edition Thigh Support Adjustable Actimove Sports Edition Shoulder Support Extra Pocket for Optional Hot/Cold Pack Actimove Professional Line PowerMotion Thigh support PowerPlay - PPKN-58 Cold and Compression Knee Wrap PowerPlay - PPHP-65 Universal Hip Orthosis PowerPlay - PPKN-360 Circumferential Knee Orthosis PowerPlay - PPBB-LBP Cold and Compression Back Wrap with One Gel Pack PowerPlay - PPBB-SP Cold and Compression Back Wrap with One Gel Pack PowerPlay - PPAN-66 Universal Ankle Orthosis PowerPlay - PPFL-27 Full Leg Cold and Compression Wrap PowerPlay - Cold Compression ROM Knee Brace with One Gel Pack Actimove Professional Line TaloCast Ankle Brace Actimove Professional Line AchilloMotion Achilles Tendon Support Actimove Sports Edition Wrist Support Elastic Wrap Around Actimove Sports Edition Ankle Support Actimove Kids Ankle Support Actimove Professional Line Talocast Actimove Sports Edition Ankle Support, Adjustable Actimove Professional Line TaloMotion Ankle Support Actimove Professional Line Closed Shell Air Walker Ankle Walker Actimove Everyday Supports Mild Ankle Support Actimove Sports Edition Ankle Stabilizer Criss-Cross Straps Actimove Closed Shell Air Walker Actimove Everyday Supports Ankle Support Actimove Arthritis Care Ankle Support Actimove Professional Line TaloBrace Comfort Ankle Brace Actimove Professional Line TaloCast Air Ankle Brace Actimove Professional Line TaloBrace Air Comfort Ankle Brace Actimove Professional Line TaloCast AirGel Ankle Brace JOBST Anti-Em GP JOBST ACTIVEWEAR JOBST Comprinet S JOBST ATHLETIC JOBST Comprinet Forte JOBST FOR MEN JOBST CASUAL PATTERN JOBST OPAQUE JOBST ULTRASHEER JOBST SOSOFT JOBST Anti-Embolism JOBST ULCERCARE JOBST TRAVEL SOCKS JOBST RELIEF JOBST Comprinet pro JOBST FOR MEN AMBITION JOBST SPORT JOBST FOR MEN CASUAL Activa

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2012-01-06
IPX	Orthosis, Rib Fracture, Soft	Physical Medicine	Class 1	890.3490	2005-12-05
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2007-04-11
KTD	Orthosis, Abdominal	Physical Medicine	Class 1	890.3490	2005-12-05
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2005-12-05
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2005-12-05
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2005-11-08
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2019-12-16
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	1983-12-27
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2007-01-23
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2005-12-05
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2005-12-06
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2021-09-13
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2013-01-16
DWL	Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)	General Hospital	Class 2	880.5780	2015-08-19
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2006-01-19
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2012-06-01
DWL	Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)	General Hospital	Class 2	880.5780	2007-11-28

Official Correspondent

No official correspondent registered.

US Agent Details

Sean Anderson Email: RegistrationTeamCLT@essity.com Phone: (959) 5997401

Related Public Records

Same Entity

BSN medical GmbH

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9615780	BSN MEDICAL	VIBRAYE Sarthe, FR
1043537	BSN medical inc.	Hickory, NC, US
8043565	BSN-JOBST GMBH	EMMERICH North Rhine-Westphalia, DE
1038963	BSN MEDICAL, INC.	CHARLOTTE, NC, US
9617266	BSN medical Limitada (COLOMBIA)	CALI Valle del Cauca, CO

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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9612388. Last updated year: 2026. Please use registration number 9612388 when referencing this establishment in official correspondence.