Johari Digital Healthcare Ltd
⚠️ Moderate Risk
FEI: 3005154439 • Jodhpur, Rajasthan • INDIA
FEI Number
3005154439
Location
Jodhpur, Rajasthan
Country
INDIAAddress
G - 582583 Boranada, , Jodhpur, Rajasthan, India
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/6/2016 | 80NRWSTIMULATOR, INTRAMUSCULAR, AUTOMATIC | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 5/29/2015 | 84NUHSTIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/29/2015 | 84NUHSTIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 11/26/2014 | 89PFWSTATIONARY ULTRASONIC DIATHERMY DEVICE FOR USE IN APPLYING THERAPEUTIC DEEP HEAT | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 11/16/2012 | 84MZNSTIMULATOR, THERAPEUTIC, ELECTROMAGNETIC | 84RX DEVICE | New Orleans District Office (NOL-DO) |
| 10/26/2010 | 89NGXSTIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 10/26/2010 | 84JXKCRANIAL ELECTROTHERAPY STIMULATOR TO TREAT DEPRESSION | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 10/26/2010 | 84LIHINTERFERENTIAL CURRENT THERAPY | 341REGISTERED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Johari Digital Healthcare Ltd's FDA import refusal history?
Johari Digital Healthcare Ltd (FEI: 3005154439) has 8 FDA import refusal record(s) in our database, spanning from 10/26/2010 to 6/6/2016.
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. Johari Digital Healthcare Ltd's FEI number is 3005154439.
What types of violations has Johari Digital Healthcare Ltd received?
Johari Digital Healthcare Ltd has been cited for 3 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 Johari Digital Healthcare Ltd come from?
All FDA import refusal data for Johari Digital Healthcare 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.