Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013473968

FEI Number

3013473968

Entity Name

Performance Health Supply, Inc.

City/State/Country

Indianapolis, IN, US

Establishment Address

9040 Orly Rd, Suite 200, Indianapolis, IN 46241, US

Establishment Type(s)

Repack or Relabel Medical Device

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

Dorsal Night Splint Moldable Thumb Spica Rapid Form Vacuum Immobilizer Pron Pillo Diamond Knee Stabilizer Medco-Pateller Sleeve Basic Patellar Support Knee Support Patellar Support Patellar Tendon Strap Medco-Knee Sleeve Hydrocollator Terry Covers Rubber Dam NON-LATEX DENTAL DAM HYGENIC DENTAL DAM Elasti-Dam COTTON TIPPED APPLICATORS Accessory Leg Strap Rolyan Cotton Stockinette Rolyan Cotton/Polyester Stockinette Cramer Team Colors Athletic Trainer's Tape Cramer 1050i Athletic Sports Tape Cramer AT Pro Athletic Tape Cramer 950 Athletic Trainer's Tape All Sports Athletic Tape Retail Cramer 750 Athletic Trainer's Tape TheraBand Kinesiology Tape DAYS 111 BARIATRIC ROLLATOR Homecraft Deluxe Walker Trolley Cramer Instant Cold Pack Sammons Preston Pain Control Care Kit 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 Deluxe Back Stabilizer Groin strain support Back support Homecraft Deluxe Shower Commode Chair Tumble Forms 2 Wedges Tumble Forms 2 Feeder Seat Tumble Forms 2 Rolls Tumble Forms 2 Weighted Blanket (all sizes, all weights) Elbow Supports 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 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 Cramer Tape Remover TIPS FOR SMALL BASE QUAD CAN, TIPS FOR LARGE BASE QUAD CANE Self-Stick Tape EcoFlex Stretch Tape Underwrap Tape Rolyan Splint Liners Neoprene Ankle Support Eclipse II Pro-Lacer Active Ankle 325 Dual Strap Support Active Ankle 329 Heel-Lock Ankle Support Active Ankle AS1 Pro Active Ankle T2 Excel Multi-Phase Ankle and Wrist Weights (Blue, Green, Red) Rolyan® Support Lumbo-Sacral Orthosis

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2025-03-12
ILZ	Accessories, Traction	Physical Medicine	Class 1	890.5925	2018-11-16
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2015-12-22
IMA	Pack, Heat, Moist	Physical Medicine	Class 1	890.5730	2015-12-28
EIE	Dam, Rubber	Dental	Class 1	872.6300	2025-03-12
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2025-03-12
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	Class 1	876.5250	2025-03-12
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2025-03-12
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2025-03-12
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2015-12-28
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2025-03-12
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2016-03-15
KNO	Accessories, Wheelchair	Physical Medicine	Class 1	890.3910	2015-12-21
MDR	Binder, Medical, Therapeutic	General Hospital	Class 1	880.5160	2025-03-12
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2015-12-21
ILT	Adaptor, Recreational	Physical Medicine	Class 1	890.5050	2016-09-07
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2025-01-31
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2015-12-21
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2016-03-07
KOX	Solvent, Adhesive Tape	General, Plastic Surgery	Class 1	878.4730	2025-03-12
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	2015-12-28
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2016-08-12
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2015-12-28
IOD	Components, Exercise	Physical Medicine	Class 1	890.5350	2025-03-12
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2015-12-22

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
2128677	PERFORMANCE HEALTH SUPPLY, LLC.	CEDARBURG, WI, US
9681624	PERFORMANCE HEALTH INTERNATIONAL LTD	SUTTON-IN-ASHFIELD Nottinghamshire, GB

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K040797	Britesmile, Inc.	BRITESMILE MASKING CREAM	2004-04-02
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
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223
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 3013473968. Last updated year: 2026. Please use registration number 3013473968 when referencing this establishment in official correspondence.