Ycy Better Health Centre
⚠️ Moderate Risk
FEI: 3004429327 • Vancouver, BC • CANADA
FEI Number
3004429327
Location
Vancouver, BC
Country
CANADAAddress
123 E Pender St, , Vancouver, BC, Canada
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/21/2007 | 87HSTAPPARATUS, TRACTION, NON-POWERED | 508NO 510(K) | Seattle District Office (SEA-DO) |
| 3/21/2007 | 87HSTAPPARATUS, TRACTION, NON-POWERED | 508NO 510(K) | Seattle District Office (SEA-DO) |
| 3/21/2007 | 87HSTAPPARATUS, TRACTION, NON-POWERED | 508NO 510(K) | Seattle District Office (SEA-DO) |
| 3/21/2007 | 84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | Seattle District Office (SEA-DO) | |
| 3/21/2007 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | Seattle District Office (SEA-DO) | |
| 3/21/2007 | 89KNMDEVICE, PRESSURE APPLYING | Seattle District Office (SEA-DO) | |
| 3/21/2007 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | Seattle District Office (SEA-DO) | |
| 3/21/2007 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | Seattle District Office (SEA-DO) | |
| 3/21/2007 | 89KNMDEVICE, PRESSURE APPLYING | Seattle District Office (SEA-DO) | |
| 3/21/2007 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | Seattle District Office (SEA-DO) | |
| 3/15/2007 | 89KNMDEVICE, PRESSURE APPLYING | 118NOT LISTED | Seattle District Office (SEA-DO) |
| 2/16/2007 | 89KNMDEVICE, PRESSURE APPLYING | Seattle District Office (SEA-DO) | |
| 12/12/2005 | 79IOBLAMP, INFRARED, PHYSICAL MEDICINE | Seattle District Office (SEA-DO) | |
| 12/5/2005 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Seattle District Office (SEA-DO) | |
| 12/5/2005 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Seattle District Office (SEA-DO) | |
| 12/5/2005 | 84GWZPERCUSSOR | Seattle District Office (SEA-DO) | |
| 12/5/2005 | 84GWZPERCUSSOR | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Ycy Better Health Centre's FDA import refusal history?
Ycy Better Health Centre (FEI: 3004429327) has 17 FDA import refusal record(s) in our database, spanning from 12/5/2005 to 3/21/2007.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Ycy Better Health Centre's FEI number is 3004429327.
What types of violations has Ycy Better Health Centre received?
Ycy Better Health Centre has been cited for 3 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Ycy Better Health Centre come from?
All FDA import refusal data for Ycy Better Health Centre is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.