All Back Care Medical
✅ Low Risk
FEI: 3005695454 • Los Angeles, CA • UNITED STATES
FEI Number
3005695454
Location
Los Angeles, CA
Country
UNITED STATESAddress
11600 Wilshire Blvd Ste 412, , Los Angeles, CA, United States
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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).
Refusal History
Frequently Asked Questions
What is All Back Care Medical's FDA import refusal history?
All Back Care Medical (FEI: 3005695454) has 2 FDA import refusal record(s) in our database, spanning from 1/20/2003 to 1/20/2003.
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. All Back Care Medical's FEI number is 3005695454.
What types of violations has All Back Care Medical received?
All Back Care Medical has been cited for 1 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 All Back Care Medical come from?
All FDA import refusal data for All Back Care Medical 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.