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Device Explorer · FDA GUDID · GMDN 34489

Pneumatic massager

An pneumatically-powered device with a vibrating head mechanism which is typically held in the hand and drawn across the area of the body/muscles to be treated. The vibrating head or pads may be interchangeable with others of different size and shape. It can b

US‑registered devices103in commercial distribution
Companies13labelers on GUDID
Single‑use2%of device records
Sterile0%labelled sterile
Prescription58%Rx‑only share
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Share of device records

Daesung Maref Co.,Ltd.5250%
Fka Distributing Co., Llc2120%
Neo Medic88%
Huizhou Xinyi Technology Co., Ltd77%
Zhangzhou Easepal Innovation Co., Ltd.33%
Merchsource, Llc33%
Shenzhen Urion Technology Co., Ltd22%
Btl Industries Limited22%

Top labelers

CompanyDevicesShare
Daesung Maref Co.,Ltd.5250%
Fka Distributing Co., Llc2120%
Neo Medic88%
Huizhou Xinyi Technology Co., Ltd77%
Zhangzhou Easepal Innovation Co., Ltd.33%
Merchsource, Llc33%
Shenzhen Urion Technology Co., Ltd22%
Btl Industries Limited22%
Dongguan City Umed Technology Co., Ltd11%
Zhejiang Luyao Electronics Technology Co., Ltd.11%
Grimm Scientific Industries Inc11%
Nuvomed, Inc.11%

Company = labeler of record on GUDID. 13 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

AnacondafightwearMotion SpaceHuBDIC Leg MassagerFED fitnessmedisanaN/ACuPiLOLUYAOCRYOPressPOWERPRESS RECOVERY UNITPOWERPRESS UNITSharper ImageNuvoMedHomedicsHOMEDICSBTL Cellutone

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

FDA product codes

CodeNameDevices
IRPMassager, Powered Inflatable Tube111
IRTPad, Heating, Powered18
ISAMassager, Therapeutic, Electric5
PBXMassager, Vacuum, Radio Frequency Induced Heat2
IPRCrutch1

GMDN & GCC registration

  • GMDN code 34489 · non‑implantable
  • Single‑use 2% · sterile 0% · Rx‑only 58% · OTC 38%
  • 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 pneumatic massager products are registered in the US?

103 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Pneumatic massager", from 13 companies. The largest labeler is Daesung Maref Co.,Ltd. with 50% of records.

Which FDA product codes apply?

IRP (Massager, Powered Inflatable Tube), IRT (Pad, Heating, Powered), ISA (Massager, Therapeutic, Electric), PBX (Massager, Vacuum, Radio Frequency Induced Heat)

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.

How do I get quotes?

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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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