SOLO LABORATORIES

FDA Device Registration & Listing · Kutztown, PA, US · Registration 3003124591

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
3003124591
FEI Number
3003124591
Entity Name
SOLO LABORATORIES
City/State/Country
Kutztown, PA, US
Establishment Address
415 S Laurel St, Kutztown, PA 19530, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
SOLO Laboratories (Owner Number: 10055493)
Owner / Operator Contact Address
415 S Laurel St, Kutztown, PA 19530, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Relief Relief+ custom orthotics

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KYS Insoles, Medical General Hospital Class 1 880.6280 2017-07-31
IQI Orthosis, Limb Brace Physical Medicine Class 1 890.3475 2024-11-11

Official Correspondent

Jonathan Naugle

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SOLO Laboratories
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003124591. Last updated year: 2026. Please use registration number 3003124591 when referencing this establishment in official correspondence.
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