AquaPulse® Irrigation Tubing
Endoscopic Irrigation/suction System
GA Health Company Limited
The following data is part of a premarket notification filed by Ga Health Company Limited with the FDA for Aquapulse® Irrigation Tubing.
Pre-market Notification Details
| Device ID | K223171 |
| 510k Number | K223171 |
| Device Name: | AquaPulse® Irrigation Tubing |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | GA Health Company Limited Unit 18, 21/F, Metropole Square, 2 On Yiu Street, Shatin Hong Kong, CN |
| Contact | Cindy Ye |
| Correspondent | Lam Wing Yu GA Health Company Limited Unit 18, 21/F, Metropole Square, 2 On Yiu Street, Shatin Hong Kong, CN |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-10-11 |
| Decision Date | 2022-11-10 |
Trademark Results [AquaPulse]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AQUAPULSE 88200334 5878056 Live/Registered |
GA HEALTH COMPANY LIMITED 2018-11-20 |
 AQUAPULSE 85291847 4059660 Dead/Cancelled |
FINIS Inc. 2011-04-11 |
 AQUAPULSE 78578772 3370245 Dead/Cancelled |
Waxman Consumer Products Group Inc. 2005-03-02 |
 AQUAPULSE 74232840 1767363 Dead/Cancelled |
SUNBEAM CORPORATION 1991-12-23 |
 AQUAPULSE 73511390 not registered Dead/Abandoned |
BRADMILL CASUALWEAR PTY. LTD. 1984-11-30 |
 AQUAPULSE 73310876 1219806 Dead/Cancelled |
Location Technology Limited 1981-05-18 |
 AQUAPULSE 73109750 1131711 Dead/Cancelled |
APPLIANCE CORPORATION OF AMERICA 1976-12-16 |
 AQUAPULSE 72283295 0876725 Dead/Expired |
WESTERN GEOPHYSICAL COMPANY OF AMERICA 1967-10-24 |
 AQUAPULSE 72283294 0884608 Dead/Expired |
WESTERN GEOPHYSICAL COMPANY OF AMERICA 1967-10-24 |
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