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Rolyan 081296003

by Performance Health Supply, LLC

Rolyan 081296003 is an external manual massager (FDA Class I; FDA product code LYG, Massager, Therapeutic, Manual) made by Performance Health Supply, LLC, listed in FDA GUDID since 4 Oct 2024 (UDI-DI 00885914038659), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00885914038659 UDI-DI Date4 Oct 2024ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Rolyan
Generic name
External manual massager, clinical
Model / reference
081296003
Primary DI / UDI-DI
00885914038659
FDA product code
LYG
GMDN term
External manual massager, clinical
Device class
Class I
Regulation number
890.5660
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code LYG (Massager, Therapeutic, Manual).

Other devices from Performance Health Supply, LLC

See all devices from Performance Health Supply, LLC →

Properties

  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
Other properties (12, all answered No)