Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004115052

FEI Number

3004115052

Entity Name

Smart Caregiver/GLOBAL DME, INC.

City/State/Country

PETALUMA, CA, US

Establishment Address

1229 N McDowell Blvd, PETALUMA, CA 94954, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Repack or Relabel Medical Device

Owner / Operator

SMART CAREGIVER CORP. (Owner Number: 9057538)

Owner / Operator Contact Address

1229 NORTH MCDOWELL BLVD., --, Petaluma, CA 94954, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Face Masks Monitor w/auto reset button,tamperproof,Pad lost LED Monitor w/voice, auto-reset, Pad lost & low battery LED Pressure pad, bed, wireless, 5"x30" Central Monitoring Unit-30 channel Pressure pad, chair, timed, 7"x15" straight cord Emergency Call Alarm Pressure pad, bed, timed, 10"x30" w/ straight cord Weight sensing floor mat, 24"x48", cordless Pressure pad, bed, 20"x30" with SafeTRelease cord pager w/LCD display Monitor , Wireless, auto reset, pad lost &low battery LED Pressure pad, bed, timed, 5"x30" straight cord Easy release seat belt Monitor w/CPI, auto-reset, Pad lost & low battery LED Central Monitoring Unit-large facility Pressure pad, chair, 10"x15" with coiled cord Pressure pad, chair, 7"x15" with coiled cord Pressure pad, bed, 5"x30" with SafeTRelease cord Pressure pad, bed, timed 10"x30" w/ SafeTRelease cord Weight sensing floor mat 24"x64" SafeTRelease cord Call Button w/ pull cord Pull string monitor Weight sensing floor mat, 24"x36 Pressure pad, bed, 10"x30" with SafeTRelease cord Monitor, pull string and pressure pad Depart Alert anti-wandering door system Pressure pad, chair, wireless, 7"x15" Monitor, CordLess, auto reset, Pad Loast &low battery LED Monitor w/ On/Off switch, pad lost&low battery LED Mounting bracket -plastic-for motion sensors Transmitter for CordLess pressure pads and floor mats Pressure pad, bed, timed 20"x30" w/SafeTRelease cord Motion Sensor with swivel bracket Pressure pad, bed, CordLess, 10"x30" Pressure pad, bed, CordLess, 20"x30" Pressure pad, bed, wireless 10"x30" Pressure pad, chair, timed, 10"x15" w/SafeTRelease cord Pressure pad, chair CordLess, 10"x15" Mounting bracket, w/clamp and flexible arm Weight sensing floor mat 24"x48 SafeTRelease cord Quick Release seat belt

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QTC	Adult Portable Bed Rails For Medical Purposes	Physical Medicine	Class 1	890.5050	2023-09-08
KMI	Monitor, Bed Patient	General Hospital	Class 1	880.2400	2012-08-21

Official Correspondent

TIMOTHY LONG

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SMART CAREGIVER CORP.

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 3004115052. Last updated year: 2026. Please use registration number 3004115052 when referencing this establishment in official correspondence.