Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023194188

FEI Number

3023194188

Entity Name

TPI Custom Solutions

City/State/Country

Ham Lake, MN, US

Establishment Address

13828 Lincoln St. NE, Ham Lake, MN 55304, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

TPI Custom Solutions (Owner Number: 10085509)

Owner / Operator Contact Address

13828 Lincoln St. NE, Ham Lake, MN 55304, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Carecube Negative Pressure Isolation Chamber Zzoma; Zzoma Positional Device; Zzoma Positional Sleeper

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LGM	Chamber, Patient Isolation	General Hospital	Class 2	880.5450	2025-05-16
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2022-06-27
MYB	Pillow, Cervical (For Mild Sleep Apnea)	Dental	Class 2	872.5570	2025-05-16

Official Correspondent

Joe Kahl

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TPI Custom Solutions

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
K100160	Sleep Specialists, LLC	ZZOMA POSITIONAL SLEEPER MODEL 001	2010-05-11
K180608	Nightbalance BV	Lunoa System	2018-06-05

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023194188. Last updated year: 2026. Please use registration number 3023194188 when referencing this establishment in official correspondence.