Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681624

FEI Number

3002903298

Entity Name

PERFORMANCE HEALTH INTERNATIONAL LTD

City/State/Country

SUTTON-IN-ASHFIELD Nottinghamshire, GB

Establishment Address

NUNN BROOK RD, HUTHWAITE, SUTTON-IN-ASHFIELD Nottinghamshire NG17 2HU, GB

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,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

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 Homecraft Deluxe Shower Commode Chair DAYS 111 BARIATRIC ROLLATOR Homecraft Deluxe Walker Trolley 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 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 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 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 Homecraft Chrome Plated Commode

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2016-03-15
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2015-12-21
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2015-12-28
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2016-03-07
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	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
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2015-12-22
INB	Attachment, Commode, Wheelchair	Physical Medicine	Class 1	890.3920	2023-11-17

Official Correspondent

Melanie Leibowitz

US Agent Details

Melanie Leibowitz Business: Performance Health Email: melanie.leibowitz@performancehealth.com Phone: (331) 6889688

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
2128677	PERFORMANCE HEALTH SUPPLY, LLC.	CEDARBURG, WI, US
3013473968	Performance Health Supply, Inc.	Indianapolis, IN, US

Related 510(k) Records

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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0011-2015	Nemschoff Chairs, Inc. 909 N 8th St 2218 Julson Ct Sheboygan WI 53081-4056	1	Nemschooff, Model Numbers - Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and Serenity IIS: 792-12. Designed to provide patient comfort during patient treatment sessions. The chair may include a manual control reclining mechanism. Customer configurable models are also available. The Serenity III Exam 791-12E was discontinued 11/1/2010.
Z-0031-2013	Winco Mfg., LLC	1	Caremor Cliner"*Manufactured By WincoOcala, FL 34474 www.wincomfg.comModel No. 536 Serial No. 536A-101475" Literature: "Caremor Cliner 5351/5361WincoISO 9001-2008 CertifiedOur most comfortable and versatile reclinerEase of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.KEY FEATURE'SInfinite positioning backPadded armrests w/arm guardWebbed elastic suspension back and seatRemovable side panelsContinuous seat & legrest cushion5351 w/tray5361 w/out tray1.800.237.33775516 SW 1st LaneOcala, Florida 34474www.wincomfg.comProudly Made in the USA*" Patient recliner chair
Z-0032-2013	Winco Mfg., LLC	1	Caremor Cliner is labeled in part: "*Manufactured By WincoOcala, FL 34474 www.wincomfg.comModel No. 535 Serial No. 535A-104522" Literature: "Caremor Cliner 5351/5361WincoISO 9001-2008 CertifiedOur most comfortable and versatile reclinerEase of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.KEY FEATURE'SInfinite positioning backPadded armrests w/arm guardWebbed elastic suspension back and seatRemovable side panelsContinuous seat & legrest cushion5351 w/tray5361 w/out tray1.800.237.33775516 SW 1st LaneOcala, Florida 34474www.wincomfg.comProudly Made in the USA*" Patient recliner chair

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681624. Last updated year: 2026. Please use registration number 9681624 when referencing this establishment in official correspondence.