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ClearLake-Tech

⚠️ Moderate Risk

FEI: 1721293 • Clear Lake, SD • UNITED STATES

FEI

FEI Number

1721293

📍

Location

Clear Lake, SD

🇺🇸
🏢

Address

205 Highway 22 E, , Clear Lake, SD, United States

Moderate Risk

FDA Import Risk Assessment

26.9
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

2
Total Refusals
3
Unique Violations
5/11/2012
Latest Refusal
2/10/2009
Earliest Refusal

Score Breakdown

Violation Severity
52.5×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
6.2×10%
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

3412×

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).

1261×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

24801×

RXPERSONAL

The article appears to be a device which requires a prescription from your doctor.

Refusal History

DateProductViolationsDivision
5/11/2012
80LDQDEVICE, GENERAL MEDICAL
2480RXPERSONAL
341REGISTERED
Cincinnati District Office (CIN-DO)
2/10/2009
84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF
126FAILS STD
341REGISTERED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is ClearLake-Tech's FDA import refusal history?

ClearLake-Tech (FEI: 1721293) has 2 FDA import refusal record(s) in our database, spanning from 2/10/2009 to 5/11/2012.

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. ClearLake-Tech's FEI number is 1721293.

What types of violations has ClearLake-Tech received?

ClearLake-Tech 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 ClearLake-Tech come from?

All FDA import refusal data for ClearLake-Tech 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.