PROTOSTHETICS

FDA Device Registration & Listing · Fargo, ND, US · Registration 3014820876

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
3014820876
FEI Number
3014820876
Entity Name
PROTOSTHETICS
City/State/Country
Fargo, ND, US
Establishment Address
510 6th Ave N, Suite D, Fargo, ND 58102, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Sapiyen LLC (Owner Number: 10082874)
Owner / Operator Contact Address
510 6TH AVENUE N, SUITE D, Fargo, ND 58102, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Protosthetics Orthotics Dakota Brace Amphibian Leg Protosthetics Socket Amphibian Water Leg

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IPT Orthosis, Thoracic Physical Medicine Class 1 890.3490 2023-01-20
IQI Orthosis, Limb Brace Physical Medicine Class 1 890.3475 2021-10-10
ISS Prosthesis, Thigh Socket, External Component Physical Medicine Class 1 890.3420 2021-10-10

Official Correspondent

Darren Jacoby

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sapiyen LLC
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 3014820876. Last updated year: 2026. Please use registration number 3014820876 when referencing this establishment in official correspondence.
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