REGENESIS BIOMEDICAL, INC.

FDA Device Registration & Listing · SCOTTSDALE, AZ, US · Registration 2032108

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
2032108
FEI Number
3003070149
Entity Name
REGENESIS BIOMEDICAL, INC.
City/State/Country
SCOTTSDALE, AZ, US
Establishment Address
5301 N Pima Rd Ste 150, SCOTTSDALE, AZ 85250, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
REGENESIS BIOMEDICAL, INC. (Owner Number: 9030652)
Owner / Operator Contact Address
5301 N. Pima Road, Ste 150, --, Scottsdale, AZ 85250, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K131979
PMA Number
N/A

All Registered Proprietary Names

Reprieve by Regenesis Provant Therapy System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat Physical Medicine Class 2 890.5290 2023-08-17
ILX Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat Physical Medicine Class 2 890.5290 2017-12-14

Official Correspondent

Randy Chavez

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

REGENESIS BIOMEDICAL, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2032108. Last updated year: 2026. Please use registration number 2032108 when referencing this establishment in official correspondence.
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