BREG, INC.

FDA Device Registration & Listing · Indianapolis, IN, US · Registration 3010694026

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010694026
FEI Number
3010694026
Entity Name
BREG, INC.
City/State/Country
Indianapolis, IN, US
Establishment Address
2835 Fortune Cir W, Indianapolis, IN 46241, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Breg Inc (Owner Number: 10041297)
Owner / Operator Contact Address
2382 Faraday Avenue, Suite 300, Carlsbad, CA 92008, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Pro-Fitt TLSO Actimove Loc 462 Ascend TLSO 456/457 Pinnacle TLSO 464 Epic LP TLSO 456 Accessories - Conversion Pad, Extension Panel IntelliFlo Pads Wrap on Polar Pads Glacier, Glacier Combo Kodiak, Kodiak Combo Cube, Cube Combo Accessories - Y-Adapter, Transformer, Strap, Battery Pack, Bed Hanger, Extension Tube Canes DVT Guardian Crutches Polar Care Cub, Cub Combo Breg Ice Bags Polar Pad Cervical Collar Cervical Traction Kit Pinnacle 172/174/180 Ascend Pediatric Collar Ascend Cervical Collar Pinnacle CTO4 Pinnacle CTO Accessories - Back Panel, Front Panel, Pad Kit, Upgrade Kit, Conversion Kit, Pads Carlsbad Cervical Collar Gel Pad Gel Wrap Cryo Pad Universal Polar Wraps Gel Pack Abdominal Binder Cervical Collar Serpentine Clavicle Support Cervical Collar with Open Trachea Intelli-Flo Dressing Polar Dressing T-Scope Hip Simple Pelvic Centron Hip Philippon Accessories - Surgical Kit, Surgical Boot, Peroneal Post, Thigh/Pelvic Pad, Cuff, Strap clip, Y-Tab POST-OP SHOE PED POST-OP SHOE MENS & WOMENS SQ TOE POST-OP SHOE KNOCKOUT WRIST NEUTRAL HAND ATTACHMENT CX2K ESSENTIAL ELBOW IMMOB THIGH SUPPORT STACK FINGER SPLINT TENNIS ELBOW STRAP ADJ DONUT CALF SLEEVE ADJ NIGHT SPLINT PHX HAND EXT TENDON COMPRESSION STRAP UNIVERSAL HORESHOE HINGED KNEE BRACE SOFTGAIT ALIGNER PHX WRIST LACER KNEE SUPPORT ELBOW TSCOPE BUTTRESS SUPPORT LAT STABILIZER X2K ELBOW M-BRACE PATELLA STABILIZER T-CHECK LACE UP ANKLE ARC DYNAMIC Synthocast Maternity Belt ABDUCTION PILLOW CONTOURED Clavicle Support FastForm SCB VERSI Strip FastForm SCB Universal Gutter Multifunctional Orthosis FastForm Wrist Cast FastForm SCB Hook & Loop refresh Strips FastForm SCB Short Arm Multifunctional Orthosis FastForm SCB Thumb Spica Multifunctional Orthosis Elasto-Fit Wrist Support Vinyl Splint Thumb Support Wrist Guard Universal Wrist Splint Universal Wrist Brace Classic Wrist Brace Versafit Wrist Brace Versafit Thumb Contender Brace Wrist Stabilizer Cock-Up Thumb Guard Wrist Cock Up Splint Thumbster Low Profile Wrist Premier Thumb Splint Wrist Mate Wrist Lacer Wrist Pro Apollo Wrist Brace Wrist Complete FastForm SCB Immobilizer FastForm SCB Hand-based thumb Spica Orthosis FastForm SCB Tension Straps Universal Thumb Lacer FastForm SCB VERSI Sheet Deluxe Shoulder Sling Arc 2 Essential Shoulder Immob. Essential Shoulder Sling Shoulder Immob. Deluxe Slingshot 3 Shoulder Abduction Pillow Slingshot Neutral Wedge Atlas Shoulder Brace Curtis Shoulder Sleeve Kool Sling Sling and Swathe Universal Curtis Shoulder Cuff Slingshot 2 Straight Shoulder Immobilizer Accessories - Waistband Strap, Shoulder Stabilizer, Sling Pediatric Accessories - Extension Strap, Closure Extension, Shoulder Strap, Hand Attachment, Shoulder Pad, Abduction Pillow PRESSURE RELIEF PAD Silicone Heel Cup Heel Lift Polar Care Wave Cold Compression Pad Transformer Y-Adapter VOLLEY TENNIS ELBOW Universal Arm Elevator Ortholux Ace Centron Lumbolux Ninja Vertalux Extender Abdominal Binder Surgical Binder Plantar Fascitic Soft Night Splint Bunion Splint Night Splint Viscoelastic Insole Ambulite Elbow VPulse Podus Guard Dorsal Night Splint Heelbo Wee Walker Achilles Boot Ultimate Ankle Axiom Ankle Integrity Walker Mid-Calf Boot AdjustaFit Boot Flatform Boot J Walker Conformer ProGait Bunion Boot Boot Cover Charcot Conformer Plantar Fasciitis Splint Hi Top / Lo Top Performance Knit Ankle Ankle Quick Wrap Wraptor VersaStrap Ankle Ankle Lace up Ankle Elastic Support Multi-Stay Ankle Shell Ankle Walker KoolAir Ankle Controlled ROM Walker Ankle Sprain Kit Boot Acsy Kit Extension Strap Ankle Stirrup Silicone Elastic Ankle Support Mini Walker Vectra Walker Ankle Brace Lock (ABL) Pin Cam Walker Ultra Ankle Ankle Walker Vectra Pro Walker Vectra Wee Walker Achilles Wedge Accessories - Cuff Kit, Bootie, Pads, Air Bladder, Straps Tri-Panel Knee Immob Original Knee OR Merit Z-13 Axiom Wee-Rom Z-12 20.50 Patellofemoral DUO Jet Thruster RLF Revolution 3 G3 Extender Plus Quantum OA T-Scope Premier Post-Op LPR Latitude OA Knee Genesis Undersleeve Patella Guard Hi-Performance Hinged Knee FreeRunner Lateral Stabilizer EPO Recover X2K Knee Brace OA Impulse Economy Hinged Knee Slide Guard ShortRunner PTO Crossover Hinge Cover RoadRunner Freestyle FreeSport Solus Knee Brace Fusion Knee Accessories - Condyle and Hook, Patella Buttress, Strap set, Strap Tab, Strap Pad, Calf Strap, Condyle, Hex Key MC Knee Brace Knee Support Accessories - Stop Kit, Soft Toe Guard, Soft Goods, Shoe Insert, Buckle, Chafe Tab, Shoe insert, Hard toe guard Accessories - Incision Pad, Pad, Pad Kit, Refurb Kit, Cuff, Wrap Set, Hinge Kit, Shims Kit CrossRunner Performance Knit Hinged Measuring System, Fit Kit Freestyle Plus TopShelf Fusion Strap Set Single Panel Knee Immob

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IPT Orthosis, Thoracic Physical Medicine Class 1 890.3490 2013-07-16
ILO Pack, Hot Or Cold, Water Circulating Physical Medicine Class 2 890.5720 2012-07-27
IPS Cane Physical Medicine Class 1 890.3075 2020-03-11
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2024-11-08
IPR Crutch Physical Medicine Class 1 890.3150 2020-03-11
KYR Bag, Ice General Hospital Class 1 880.6050 2012-08-31
ILO Pack, Hot Or Cold, Water Circulating Physical Medicine Class 2 890.5720 2012-08-17
IQK Orthosis, Cervical Physical Medicine Class 1 890.3490 2013-01-30
IME Pack, Hot Or Cold, Reusable Physical Medicine Class 1 890.5700 2012-08-17
IPY Orthosis, Lumbo-Sacral Physical Medicine Class 1 890.3490 2012-08-17
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2012-08-17
ITS Joint, Hip, External Brace Physical Medicine Class 1 890.3475 2013-03-25
IPG Shoe, Cast Physical Medicine Class 1 890.3025 2012-08-17
IQI Orthosis, Limb Brace Physical Medicine Class 1 890.3475 2012-07-10
HXT Tape, Orthopedic General, Plastic Surgery Class 1 878.4800 2022-06-07
FSD Binder, Abdominal General Hospital Class 1 880.5160 2022-06-07
IQJ Splint, Clavicle Physical Medicine Class 1 890.3490 2017-02-01
ILH Splint, Hand, And Components Physical Medicine Class 1 890.3475 2012-08-17
ILI Sling, Arm Physical Medicine Class 1 890.3640 2012-08-17
KYS Insoles, Medical General Hospital Class 1 880.6280 2012-08-17
ILO Pack, Hot Or Cold, Water Circulating Physical Medicine Class 2 890.5720 2019-06-12
IRP Massager, Powered Inflatable Tube Physical Medicine Class 2 890.5650 2019-06-12
IOY Support, Arm Physical Medicine Class 1 890.3475 2014-05-12
MRI Orthosis, Truncal/Orthosis, Limb Physical Medicine Class 1 890.3490 2015-05-17
KTD Orthosis, Abdominal Physical Medicine Class 1 890.3490 2017-02-01
IQM Splint, Temporary Training Physical Medicine Class 1 890.3025 2012-08-17
KIC Cushion, Flotation Physical Medicine Class 1 890.3175 2022-06-07
ILE Sling, Arm, Overhead Supported Physical Medicine Class 1 890.3475 2022-06-07
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2015-07-31
ITW Joint, Ankle, External Brace Physical Medicine Class 1 890.3475 2012-08-17
ITQ Joint, Knee, External Brace Physical Medicine Class 1 890.3475 2012-07-27

Official Correspondent

Monique Zamora

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Breg Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3015960622 BREG MEXICO, S. DE R.L. DE C.V. (3) Mexicali Baja California, MX
2028253 BREG, INC., Carlsbad, CA, US
3027500264 BREG MEXICO, S. DE R.L. DE C.V. (4) Mexicali Baja California, MX

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
K843874 Beiersdorf, Inc. LEUKOPOR SURGICAL TAPE 1985-02-21
K915446 Sun Glitz Corp. STRETCH WRAP 1992-05-06
K833120 Acme United Corp. ONE TIME COMPOUND BENZOIN TINCTURE- 1983-12-29

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 3010694026. Last updated year: 2026. Please use registration number 3010694026 when referencing this establishment in official correspondence.
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