Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2128677

FEI Number

2128677

Entity Name

PERFORMANCE HEALTH SUPPLY, LLC.

City/State/Country

CEDARBURG, WI, US

Establishment Address

W68 N158 EVERGREEN BLVD., CEDARBURG, WI 53012, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Performance Health Supply (Owner Number: 10050734)

Owner / Operator Contact Address

3333 Finley Road, Suite 575, Downers Grove, IL 60515, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ROLYAN INCLINE BOARD ROLYAN DIGI-BLOCK HAND ROLYAN WORK BENCH Tumble Forms 2 Deluxe Vestibulator ROLYAN SEMI CIRCULAR PEG BOARD ROLYAN FOREARM BASED SKATEBOARD & ACCESSORIES ROLYAN COMPLEX FORM BOARD ROLYAN VERTICAL RING TREE ROLYAN SENSORY TESTING SHIELD Tumble Forms 2 Neurodevelopment Training Balls ROLYAN STACKING CONE PATTERN BASE ROLYAN PRONATION SUPINATION ROLYAN HORIZONTAL RING TREE Rolyan Cotton Stockinette Rolyan Cotton/Polyester Stockinette Tumble Forms 2 Wedges Tumble Forms 2 Feeder Seat Tumble Forms 2 Rolls Tumble Forms 2 Weighted Blanket (all sizes, all weights) Rolyan Gel Pad Sammons Preston Heel/Elbow Protectors Semi-Compressed Mixed Felt *9 Rolyan AquaForm (all types) ROLYAN INCREMENTAL WRIST HINGE Rolyan Aquaplast Resilient-T ROLYAN POST SURGICAL ARM SUPPORT Rolyan CuraDrape ROLYAN WEDGE FLEX ROLYAN STRAPS - ALL CONFIGURATIONS & ACCESSORIES Rolyan Aquaplast Original ROLYAN DYNAMIC PRONATION/SUPINATION KIT POSTERIOR LEAF SPLINT Rolyan Ezeform Rolyan Aquaplast-T PADDING - ALL THICKNESSES & CONFIGURATIONS Rolyan Synergy Rolyan Polyform ROLYAN ANKLE FOOT ORTHOSIS Rolyan Polyflex II Rolyan Tailorsplint Rolyan Aquaplast Watercolors Rolyan Aquaplast Original Resilient Rolyan Aquaplast Prodrape-T CMC Abduction Splint Spring Finger Extension Splint Rolyan Sof-Stretch Short Extension Splint ROLYAN WRAP-ON FINGER HOOKS ROLYAN PROGR. PALM PROTECTOR SERIES ROLYAN PIP LIGAMENT REPAIR ROLYAN ADJUSTABLE OUTRIGGERS ROLYAN CARVE-IT HAND SERIES ROLYAN TAP SPLINT SERIES ROLYAN KWIK-FORM SERIES ROLYAN IN-LINE THUMB SPLINT SERIES ROLYAN THUMB LOOP SERIES Rolyan Sof-Stretch Extension Splint Thumb CMC Restriction Splint Wrist and Thumb CMC Restriction Splint Jamar Hand Dynamometer Self-Stick Tape EcoFlex Stretch Tape Underwrap Tape Rolyan Splint Liners Rolyan® Support Lumbo-Sacral Orthosis TIPS FOR SMALL BASE QUAD CAN, TIPS FOR LARGE BASE QUAD CANE Sammons Preston Standard Gait Belts PADDED GAIT BELT Sammons Preston Quick Clean Gait Belt Homecraft Uni-Frame Folding Toilet Rail Homecraft Sturdy Bath Tub Grab Bar Homecraft Devon Elite Height Adjustable Folding Support Rail Homecraft Curved Transfer Board Homecraft Orbi-Turn Sammons Preston Padded Gait Belt Homecraft Devon Elite Folding Support Rail Sammons Preston Quick-Release Homecraft Fully Adjustable Toilet Surround ROLYAN LAP TRAY ROLYAN TORSO SUPPORT ROLYAN ARM TRAY PILLOW LEG REST BUMPER Homecraft Lightweight Foam Handled Cutlery Homecraft Queens Cutlery Homecraft Caring Cutlery Set Homecraft Kings Assessment Kit Sammons Preston Sure Grip Bendable Utensils Sammons Preston Sure Grip Utensils Homecraft Raised Toilet Seat Homecraft Ocean Wheeled Shower Commode Chair Homecraft Corner Shower Stool Homecraft Sherwood Plus Bariatric Shower Stools Homecraft Lightweight Cut-out Shower Chair Homecraft Round Shower Stool Homecraft Savanah Showerboard Prima Bath Step Prima Slatted Bathseat Homecraft Ocean Heavy Duty Shower Stool Homecraft Atlantic Commode and Shower Chair Homecraft Savanah Raised Toilet Seat Adjustable Height Bath Seat Ashby Easy Fit 4" Raised Toilet Seat Wide Acess Toilet Seat Savanah Slatted Bathseat Homecraft Sherwood Plus Perching Stool Tumble Forms 2 Carrie Potty Seat Derby Half Step

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2015-12-21
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2025-03-12
ILT	Adaptor, Recreational	Physical Medicine	Class 1	890.5050	2016-09-07
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2015-12-21
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2015-12-22
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2016-03-07
HRW	Dynamometer, Nonpowered	Orthopedic	Class 1	888.1250	2019-01-17
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2016-08-12
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2015-12-22
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	2015-12-28
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2016-03-15
KNO	Accessories, Wheelchair	Physical Medicine	Class 1	890.3910	2015-12-21
ILC	Utensil, Eating	Physical Medicine	Class 1	890.5050	2023-11-17
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2015-12-21

Official Correspondent

Melanie Leibowitz

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Performance Health Supply

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3035385409	Performance Health Canada, Inc.	Mississauga Ontario, CA
3009542966	Performance Health Bingley	Bingley, West Yorkshire Bradford, GB
2435707	TUMBLE FORMS, INC.	DOLGEVILLE, NY, US
3013473968	Performance Health Supply, Inc.	Indianapolis, IN, US
9681624	PERFORMANCE HEALTH INTERNATIONAL LTD	SUTTON-IN-ASHFIELD Nottinghamshire, GB

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2128677. Last updated year: 2026. Please use registration number 2128677 when referencing this establishment in official correspondence.