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Device Explorer · FDA GUDID · GMDN 34661

External manual massager, home-use

A manual (non-powered) device specifically designed to apply external massage in the home. It is typically held in the hand of the user and drawn/rolled across the area of the body/muscles to be treated; it may also be designed to be placed on the floor for fo

US‑registered devices65in commercial distribution
Companies11labelers on GUDID
Single‑use5%of device records
Sterile0%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Dongguan Dengrong Arts & Crafts Co., Ltd.2335%
Fourstar Group Inc.1929%
Lucky Dragon Enterprise Group Inc.1015%
Stiff Mother Trucker Llc35%
Jiangmen Shengke Hardware Products Co., Ltd23%
Merchsource, Llc23%
Feldi Srl23%
J.B.International Company12%

Top labelers

CompanyDevicesShare
Dongguan Dengrong Arts & Crafts Co., Ltd.2335%
Fourstar Group Inc.1929%
Lucky Dragon Enterprise Group Inc.1015%
Stiff Mother Trucker Llc35%
Jiangmen Shengke Hardware Products Co., Ltd23%
Merchsource, Llc23%
Feldi Srl23%
J.B.International Company12%
Accurate Surgical & Scientific Instruments Corporation12%
Vive Health Llc12%
Alimed, Inc.12%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ARTSUNTRI WINLucky DragonRoad Relief WellnessStainless Steel Facial Ice GlobeSharper ImageASSIVIVEROLLER 2LB BLK 6X36B PureB-PURETesmed CELLULITE

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

FDA product codes

CodeNameDevices
LYGMassager, Therapeutic, Manual199
ISAMassager, Therapeutic, Electric8
GEACannula, Surgical, General & Plastic Surgery1
IONEXERCISER, NON-MEASURING1

GMDN & GCC registration

  • GMDN code 34661 · non‑implantable
  • Single‑use 5% · sterile 0% · Rx‑only 0% · OTC 9%
  • 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 external manual massager, home-use products are registered in the US?

65 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "External manual massager, home-use", from 11 companies. The largest labeler is Dongguan Dengrong Arts & Crafts Co., Ltd. with 35% of records.

Which FDA product codes apply?

LYG (Massager, Therapeutic, Manual), ISA (Massager, Therapeutic, Electric), GEA (Cannula, Surgical, General & Plastic Surgery), ION (EXERCISER, NON-MEASURING)

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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