CRYON-X LLC

FDA Device Registration & Listing · Shelton, CT, US · Registration 3033648890

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3033648890
FEI Number
3033648890
Entity Name
CRYON-X LLC
City/State/Country
Shelton, CT, US
Establishment Address
1 Parrott Dr Ste 400, Shelton, CT 06484, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
CRYON-X LLC (Owner Number: 10091949)
Owner / Operator Contact Address
631 Wald, Irvine, CA 92618, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K223541
PMA Number
N/A

All Registered Proprietary Names

Cryon-X GO Wraps Cryon-X One Cryon-X PRO

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IRP Massager, Powered Inflatable Tube Physical Medicine Class 2 890.5650 2025-03-21
ILO Pack, Hot Or Cold, Water Circulating Physical Medicine Class 2 890.5720 2025-03-21
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2025-03-21

Official Correspondent

Bill Dai

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CRYON-X LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K242140 Jiale Health Technology Shenzhen Co., Ltd. Air Compression Leg Massager (K-705) 2025-03-17
K170216 Tactile Systems Technology, Inc. (Dba Tactile Medical) Flexitouch System 2017-05-26
K100306 Covidien KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES 2010-05-04

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033648890. Last updated year: 2026. Please use registration number 3033648890 when referencing this establishment in official correspondence.
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