Oyaga Beauty Equipment Co Ltd
⚠️ Moderate Risk
FEI: 3007189701 • Guangzhou, Guangdong • CHINA
FEI Number
3007189701
Location
Guangzhou, Guangdong
Country
CHINAAddress
No 142 Dongfeng West Rd, , Guangzhou, Guangdong, China
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
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 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.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/10/2011 | 79OHVFOCUSED ULTRASOUND FOR TISSUE HEAT OR MECHANICAL CELLULAR DISRUPTION | Cincinnati District Office (CIN-DO) | |
| 2/10/2011 | 79GFEBRUSH, DERMABRASION | Cincinnati District Office (CIN-DO) | |
| 2/10/2011 | 89HPHDIATHERMY, MICROWAVE, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP HEAT | Cincinnati District Office (CIN-DO) | |
| 10/13/2009 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Florida District Office (FLA-DO) | |
| 10/13/2009 | 97RALMASSAGER, ULTRASONIC NON-MEDICAL DEVICES | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Oyaga Beauty Equipment Co Ltd's FDA import refusal history?
Oyaga Beauty Equipment Co Ltd (FEI: 3007189701) has 5 FDA import refusal record(s) in our database, spanning from 10/13/2009 to 2/10/2011.
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. Oyaga Beauty Equipment Co Ltd's FEI number is 3007189701.
What types of violations has Oyaga Beauty Equipment Co Ltd received?
Oyaga Beauty Equipment Co Ltd has been cited for 4 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 Oyaga Beauty Equipment Co Ltd come from?
All FDA import refusal data for Oyaga Beauty Equipment Co Ltd 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.