Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9612061

FEI Number

3003518194

Entity Name

OSIM International Pte. Ltd.

City/State/Country

SINGAPORE South East, SG

Establishment Address

65 UBI AVENUE 1, OSIM HQ, SINGAPORE South East 408939, SG

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

OSIM International Pte. Ltd. (Owner Number: 9031040)

Owner / Operator Contact Address

65 Ubi Avenue 1, OSIM HQ, Singapore, SG-NOTA 408939, SG

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OS-318 uPhoria OS-2262 uErgoh Air OS-3605 uRelax OS-918 uPixie OS-820 uAstro 2 OS-102 uCozy OS-338 uPhoria Warm OS-845 uDiva OS-838 uInfinity OS-344 uSqueez Air OS-238 uCozy 3D OS-420 uPen OS-158 uCrown 3 OS-112 uGalaxy OS-253 uPamper 2 OS-856 uDiva Classic OS-858 uMagic OS-868 uLove OS-268 uCozy 3D OS-860 uDeluxe OS-260 uJolly OS-8201 uThrone OS-888 uLove 2 OS-8218 uLove 3 OS-393 uSqueez 2 OS-8213 uThrone S OS-8212 uDivine V2 OS-8208 uDream OS-8210 uDeluxe Max OS-8219 uInfinity Pro OS-2233 uJolly Sync OS-290S uJolly 2 Smart OS-8211 uDiva 3 OS-8215 uThrone V OS-8242 uDivine V3 OS-2212 uRoller X-Sports OS-2215 uCozy X-Sports OS-8231 uDiva SOFA OS-3233 uPhoria Sync OS-322 uSqueez App OS-8260 uDeluxe 4 OS-3260 uSqueez 4 OS-833 uDivine S OS-5205 uGoGo OS-322IV uSqueez App OS-323 uPebble OS-8259 uDream.AI s OS-8258 uDream.AI OS-922 uSlender OS-253 uPamper 2 OS-868 uLove OS-158 uCrown 3 OS-112 uGalaxy OS-260 uJolly OS-860 uDeluxe OS-935 uShape OS-9015 uBuzz OS-338 uPhoria Warm OS-856 uDiva Classic OS-268 uCozy 3D

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2005-12-27
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	1997-07-11

Official Correspondent

Christina Cheong

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

OSIM International Pte. Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9612061. Last updated year: 2026. Please use registration number 9612061 when referencing this establishment in official correspondence.