Health Technology (Pty) Ltd
⚠️ Moderate Risk
FEI: 3007843485 • Springfield Park • SOUTH AFRICA
FEI Number
3007843485
Location
Springfield Park
Country
SOUTH AFRICAAddress
Unit 3, 6 Palmfield Road, , Springfield Park, , South Africa
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.
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.
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.
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/3/2021 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of Southeast Imports (DSEI) | |
| 10/26/2012 | 89IPFSTIMULATOR, MUSCLE, POWERED | New England District Office (NWE-DO) | |
| 10/26/2012 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | New England District Office (NWE-DO) | |
| 6/1/2012 | 89EGJDEVICE, IONTOPHORESIS, OTHER USES | New England District Office (NWE-DO) |
Frequently Asked Questions
What is Health Technology (Pty) Ltd's FDA import refusal history?
Health Technology (Pty) Ltd (FEI: 3007843485) has 4 FDA import refusal record(s) in our database, spanning from 6/1/2012 to 2/3/2021.
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. Health Technology (Pty) Ltd's FEI number is 3007843485.
What types of violations has Health Technology (Pty) Ltd received?
Health Technology (Pty) Ltd has been cited for 7 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 Health Technology (Pty) Ltd come from?
All FDA import refusal data for Health Technology (Pty) 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.