HomeUSAPerformance Health Inc.

Performance Health Inc.

USA · Downers Grove IL · www.performancehealth.com
✓ Record-verifiedregistrations found in 9 marketsEU SRN GB-MF-000003319

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Canada, Taiwan, Australia, Israel — 9 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
≥300UDI-DI device records
Class I 300
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
41listed device types
Class I 41Class II 0Class III 0
plus 65 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
41registered device records
Class I 41
BRBrazilANVISA
1registered devices
Class I 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
47registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
2active device licences
Class II 2
TWTaiwanTFDA
3valid device licences
Class I 3
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
6active ARTG entries
Class I 5IIa 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union1,224 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified
United States65 registration records, 0 510(k), 0 PMA, 32 excluded
United Kingdom41 confirmed, 5 excluded
Brazil1 confirmed, 1 excluded
Saudi Arabia47 confirmed, 0 excluded
Canada2 confirmed, 2 excluded
Manufacturer names merged into this page: PERFORMANCE HEALTH SUPPLY, LLC. · PERFORMANCE HEALTH INTERNATIONAL LTD · Performance Health Supply, Inc. · Performance Health Bingley · PERFORMANCE HEALTH SUPPLY, INC. · PERFORMANCE HEALTH, INC

Regulatory identity

EU manufacturer SRN
GB-MF-000003319
EU authorised representative
AR Experts B.V.
UK responsible person
UKCA Experts Ltd

Company information

Country
USA
City
Downers Grove IL
Website
www.performancehealth.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesOrthopaedics, Trauma & RehabilitationPhysiotherapy equipmentAssistive mobility technologiesIntegrated Care, Rehabilitation & HomecareHomecare, long-term care & ageing

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Legal name
PERFORMANCE HEALTH HOLDINGS, INC.
LEI
254900ZAQ0N9AHY1Q982
Registration status
Active
Legal form
Corporation
Incorporated
2000-08-25
Registered address
C/O CORPORATION SERVICE COMPANY, WILMINGTON, 19808
Registration authority
Division of Corporations, Department of State, no. 3274677
Registry record updated
2026-08-31

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA listed device types

showing 8 of 41
Solvent, Adhesive Tape 1Splint, Hand, And Components 1Adaptor, Recreational 1Exerciser, Non-Measuring 1Orthosis, Limb Brace 1Dynamometer, Nonpowered 1Bag, Ice 1Binder, Medical, Therapeutic 1

Registration details (sample)

MarketIdentifierNameClass / date
EU05028318974306Days Chrome Plated Steel WheelchairClass I
EU05028318917686Days Swift WheelchairClass I
EU05028318917655Days Swift WheelchairClass I
EU05028318917624Days Swift WheelchairClass I
UK35089MugsClass I
UK36206Ankle OrthosisClass I
UK31197Assistive cutleryClass I
BR10178010185PLACA TERMOPLÁSTICA PARA IMOBILIZAÇÃOClass I
SAME0000013123SFDAA00001Homecraft Devon Support Rails
SAME0000009694SFDAA00006uk Wheelchair Extra Wide H Duty
CA95440PERFORMA ELECTRODESClass II
CA96338JAMAR PLUS + DIGITAL HAND DYNAMOMETERClass II

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