Device Explorer · FDA GUDID · GMDN 17198

Pillow speaker

A loudspeaker intended to be used by a patient when lying in bed or resting in a chair by putting it close to their ear or between a pillow and their ear. It is typically designed as a small pillow-like device that contains a loudspeaker and that has a cable a

US‑registered devices6,790in commercial distribution
Companies3labelers on GUDID
Single‑use0%of device records
Sterile13%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Curbell Medical Products, Inc.5,92587%
Anacom Medtek85213%
Hatchmed Corporation130%

Top labelers

CompanyDevicesShare
Curbell Medical Products, Inc.5,92587%
Anacom Medtek85213%
Hatchmed Corporation130%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

HighLightPadLockPillowCaseRESPONDER 5, INTERACTIVEGEN4 INTERACTIVEGEN4 DIRECT ACCESS"PAD WIRELESS, UNDER SEAT, 10""X15"""GEN4 DIGITAL4600,R6,ENH,2 LT,DV4600,R6,BASIC,2 LT,DVP4600 90°,S4600,1 FT,R6,PS BREAKAWAYGEN4 PLUS, DIRECT ACCESSSAFE MOBILITY LIGHT KIT,XMIT,PAD,PWR 8'GEN4 PLUS, RESPONDER 5, ENHANCEDRESPONDER 5, STANDARDGEN4 AUSTCO TACERA ENTERTAINMENT

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
ILQSystem, Communication, Powered5,194
IQASystem, Environmental Control, Powered1,758
FNLBed, Ac-Powered Adjustable Hospital5

GMDN & GCC registration

  • GMDN code 17198 · non‑implantable
  • Single‑use 0% · sterile 13% · Rx‑only 0% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

How many pillow speaker products are registered in the US?

6,790 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Pillow speaker", from 3 companies. The largest labeler is Curbell Medical Products, Inc. with 87% of records.

Which FDA product codes apply?

ILQ (System, Communication, Powered), IQA (System, Environmental Control, Powered), FNL (Bed, Ac-Powered Adjustable Hospital)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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