WUHAN PHOMED TECHNOLOGY CO LTD
⚠️ Moderate Risk
FEI: 3026939957 • Wuhan, Hubei • CHINA
FEI Number
3026939957
Location
Wuhan, Hubei
Country
CHINAAddress
East Lake New Room, 3f Building 2, Gezhouba Sun City, No. 40 Gaoxin 4th Road; Huashanzhen, Wuhan, Hubei, 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
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
3904
DV NAME
The article appears to be a device and its labeling fails to bear the proprietary or established name.
3905
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/24/2025 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | Division of Southeast Imports (DSEI) | |
| 10/21/2025 | 95RHLLASER THERAPY PRODUCT | Division of Southeast Imports (DSEI) | |
| 10/7/2025 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is WUHAN PHOMED TECHNOLOGY CO LTD's FDA import refusal history?
WUHAN PHOMED TECHNOLOGY CO LTD (FEI: 3026939957) has 3 FDA import refusal record(s) in our database, spanning from 10/7/2025 to 10/24/2025.
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. WUHAN PHOMED TECHNOLOGY CO LTD's FEI number is 3026939957.
What types of violations has WUHAN PHOMED TECHNOLOGY CO LTD received?
WUHAN PHOMED TECHNOLOGY CO LTD has been cited for 6 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 WUHAN PHOMED TECHNOLOGY CO LTD come from?
All FDA import refusal data for WUHAN PHOMED TECHNOLOGY 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.