GYMFORM ABS-A-ROUND
Stimulator, Muscle, Powered, For Muscle Conditioning
WELL BRAIN INTERNATIONAL, LTD.
The following data is part of a premarket notification filed by Well Brain International, Ltd. with the FDA for Gymform Abs-a-round.
Pre-market Notification Details
| Device ID | K130074 |
| 510k Number | K130074 |
| Device Name: | GYMFORM ABS-A-ROUND |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | WELL BRAIN INTERNATIONAL, LTD. RM.1212, 12 FL, HARBOUR CRYSTAL CENTRE, NO. 100 GRANVILLE RD Hong Kong, CN 999077 |
| Contact | Victor K Wai |
| Correspondent | Victor K Wai WELL BRAIN INTERNATIONAL, LTD. RM.1212, 12 FL, HARBOUR CRYSTAL CENTRE, NO. 100 GRANVILLE RD Hong Kong, CN 999077 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-14 |
| Decision Date | 2013-08-15 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973698299824 | K130074 | 000 |
Trademark Results [GYMFORM ABS-A-ROUND]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GYMFORM ABS-A-ROUND 88934955 not registered Live/Pending |
Actervis GmbH 2020-05-27 |
 GYMFORM ABS-A-ROUND 85807366 not registered Dead/Abandoned |
Actervis GmbH 2012-12-20 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.