International Regulatory Information
Certifications
CE production Quality Assurance
Directive 93/42/EEC
Quality Management System
ISO13485:2016; EN ISO 13485:2016
MDSAP (ISO13485:2016)
Restorative Therapies, Inc is audited every year by:
SGS USA
75 Passaic Avenue
Fairfield, New Jersey 07004
United States
United States
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
XciteV2
Maryland Residential Service Agency license:
R3932
Argentina
Declaration of Conformity:
RT300, RT200, RT600, Xcite
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
Canada
Medical device licenses:
RT300
RT600
RT200
Xcite Clinical Station
RT60 six channel stimulator
RT50 single channel stimulator
Canadian Standards Association (CSA) Listing:
RT300-SL, SLSA, SLP, LSA, SLA
RT300 Supine/SA
RT600
Xcite
China
Medical device registrations:
RT200
Europe
Declaration of Conformity:
RT300
RT600
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
Hong Kong
Declaration of Conformity:
RT300
India
Authorized Representative
NV Genomics Pvt Ltd
95 Sector 19, Pocket 3,
Dwarka, New Delhi, Delhi 110075, India
https://www.nvgenomics.com/
Kazakhstan
Regulatory Approval:
RT300, RT600, RT200
Malaysia
Regulatory Approval:
RT300
Xcite Clinical Station
New Zealand
WAND Registration:
RT300
Xcite Clinical Station
Russia
Regulatory Approval:
RT300, RT600, RT200
Turkey
Regulatory Approval:
RT300
United Arab Emirates
Regulatory Clerance:
RT300 (DRCLAS-2021-005092)
Xcite (DRCLAS-2021-005094)