International Regulatory Information

Certifications

CE production Quality Assurance
Directive 93/42/EEC

Quality Management System 
ISO13485:2016; EN ISO 13485:2016

Restorative Therapies, Inc is audited every year by:
SGS USA
75 Passaic Avenue
Fairfield, New Jersey 07004
United States

SGS ISO 13485 System Certification Logo

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United States

US FDA Good Manufacturing Practice (GMP)
We are fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations.

FDA 510(k) cleared devices:
RT300: K060032  K050036 K071113 K071486 K072398 K090750  K162470
RT600: K103366
RT200: K103370
Xcite:   K160614

FDA listing number:
RT300: D303875
RT600: D198138
RT200: D203325
Xcite:   D284299

FDA registration number: 3004733458
Primary SIC: 3841 (Surgical And Medical Instruments)
Primary NAICS: 334510 (Electromedical and Electrotherapeutic Apparatus Manufacturing)

Nationally Recognized Testing Laboratory (NRTL) Listing:
RT300-SL, SLSA, SLP, LSA, SLA
RT300 Supine/SA
RT600
Xcite

FAQ about NRTL Listing

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Argentina 

Declaration of Conformity (PDF format):
RT30, RT200, RT600, Xcite

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Australia

Business registration:
ABN 28 131 719 661

ARTG Certificates:
RT300, RT600, RT200: ARTG# 176355
Xcite: ARTG# 284186

Declaration of Conformity:
RT300
RT600
RT200
Xcite Clinical Station

Sponsor for regulatory affairs issues and incident reporting:
Emergo Australia
Level 20, Tower II
Darling Park
201 Sussex Street
Sydney, NSW 2000
Australia

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Canada

Medical device licenses:
RT300
RT600
RT200
Xcite Clinical Station
RT50 single channel stimulator

Declaration of Conformity (PDF format):
RT300
RT600
RT200
Xcite Clinical Station
RT50 single channel stimulator

Canadian Standards Association (CSA) Listing:
RT300-SL, SLSA, SLP, LSA, SLA
RT300 Supine/SA
RT600
Xcite

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China

Medical device registrations:
RT200

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Colombia

Medical device registrations:
RT300 
RT600
RT200

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Europe

Declaration of Conformity:
RT300
RT600
RT200
Xcite Clinical Station

Representative for regulatory affairs issues and incident reporting:
Emergo Europe
Prinsessegracht 20
2514 AP The Hague
NETHERLANDS
Tel: +31 (0) 70 345 8570

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Hong KongDeclaration of Conformity (PDF format):
RT300

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Kazakhstan

Regulatory Approval:
RT300, RT600, RT200

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New Zealand

WAND Registration:
RT300
Xcite Clinical Station

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Russia

Regulatory Approval:
RT300, RT600, RT200

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Singapore

Regulatory Approval:
RT300, RT600, RT200

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Turkey

Regulatory Approval:
RT300