China Shotmay Beauty Equipment Co
⚠️ Moderate Risk
FEI: 3009230451 • Guangzhouguangzhou • CHINA
FEI Number
3009230451
Location
Guangzhouguangzhou
Country
CHINAAddress
Company Location: #12 Industrial, , Guangzhouguangzhou, , 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).
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/12/2011 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Cincinnati District Office (CIN-DO) | |
| 12/12/2011 | 89ILXDIATHERMY, SHORTWAVE, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP HEAT | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is China Shotmay Beauty Equipment Co's FDA import refusal history?
China Shotmay Beauty Equipment Co (FEI: 3009230451) has 2 FDA import refusal record(s) in our database, spanning from 12/12/2011 to 12/12/2011.
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. China Shotmay Beauty Equipment Co's FEI number is 3009230451.
What types of violations has China Shotmay Beauty Equipment Co received?
China Shotmay Beauty Equipment Co 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 China Shotmay Beauty Equipment Co come from?
All FDA import refusal data for China Shotmay Beauty Equipment Co 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.