Home Care Technology Co., Ltd.
⚠️ Moderate Risk
FEI: 3003514353 • Tainan City • TAIWAN
FEI Number
3003514353
Location
Tainan City
Country
TAIWANAddress
116, Lane 523, Section 3, Jhongjheng Rd, Rende District, Tainan City, , Taiwan
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
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).
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.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/27/2021 | 89IPFSTIMULATOR, MUSCLE, POWERED | 84RX DEVICE | Division of Southeast Imports (DSEI) |
| 6/17/2020 | 89IPFSTIMULATOR, MUSCLE, POWERED | Division of West Coast Imports (DWCI) | |
| 1/23/2012 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Los Angeles District Office (LOS-DO) | |
| 1/23/2012 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Los Angeles District Office (LOS-DO) | |
| 10/31/2007 | 89IMEPACK, HOT OR COLD, REUSEABLE | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/31/2007 | 89IMIDIATHERMY, ULTRASONIC, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/31/2007 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 341REGISTERED | Florida District Office (FLA-DO) |
| 3/4/2002 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Home Care Technology Co., Ltd.'s FDA import refusal history?
Home Care Technology Co., Ltd. (FEI: 3003514353) has 8 FDA import refusal record(s) in our database, spanning from 3/4/2002 to 5/27/2021.
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. Home Care Technology Co., Ltd.'s FEI number is 3003514353.
What types of violations has Home Care Technology Co., Ltd. received?
Home Care 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 Home Care Technology Co., Ltd. come from?
All FDA import refusal data for Home Care 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.