Skip to content

Sharper Image 1019357

by Merchsource LLC

Sharper Image 1019357 is a Class II device made by Merchsource LLC, cleared under FDA 510(k) K251531 on 30 Oct 2025 and listed in FDA GUDID since 28 Jun 2026 (UDI-DI 00840397513352), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K251531

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840397513352 UDI-DI Date28 Jun 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK251531 Date30 Oct 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K251531 decided 30 Oct 2025 Active
  • FDA GUDID UDI-DI 00840397513352 listed 28 Jun 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K251531
  2. Listed FDA GUDID 00840397513352

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Sharper Image
Generic name
Pneumatic massager
Model / reference
1019357
Primary DI / UDI-DI
00840397513352
510(k) Number
FDA product code
IRP
GMDN term
Pneumatic massager
Device class
Class II
Regulation number
890.5650
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code IRP (Massager, Powered Inflatable Tube).

Other devices from Merchsource LLC

See all devices from Merchsource LLC →

Properties

  • Over-the-counter
Other properties (14, all answered No)