Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8040494

FEI Number

1000178419

Entity Name

P. GOPALDAS LTD.

City/State/Country

KOWLOON, HONG KONG, CN

Establishment Address

605A-607A EMPIRE CENTRE, 68 MODY RD., TST EAST,, KOWLOON, HONG KONG --, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

P. GOPALDAS LTD. (Owner Number: 8040494)

Owner / Operator Contact Address

605A-607A EMPIRE CENTRE, 68 MODY ROAD KOWLOON, HONG KONG, HK-NOTA 000, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Seven Creations BATTERY-POWERED THERAPEUTIC PHYSICAL MEDICINE VIBRATOR A.C. POWERED

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KXQ	Vibrator For Therapeutic Use, Genital	Obstetrics/Gynecology	Class 2	884.5960	2020-09-08
IRO	Vibrator, Therapeutic	Physical Medicine	Class 1	890.5975	1987-02-16

Official Correspondent

MANESH DARYANANI

US Agent Details

KRISTIAN BROMS Business: PIPEDREAM PRODUCTS INC. Email: KRISTIAN@DIAMONDPROD.COM Phone: (818) 2598841

Related Public Records

Same Entity

P. GOPALDAS LTD.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K821133	Durham Electric Co.	ELECTRICAL VIBRATING DEVICE	1982-07-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8040494. Last updated year: 2026. Please use registration number 8040494 when referencing this establishment in official correspondence.