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Healthpal FE-7108

by Xiamen Healthpal Electronic Co., Ltd

Healthpal FE-7108 is a Class II device made by Xiamen Healthpal Electronic Co., Ltd, cleared under FDA 510(k) K211850 on 3 Mar 2022 and listed in FDA GUDID since 26 Aug 2026 (UDI-DI 06974000130033), active as of 22 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 22 Oct 2026

Documents

510(k) K211850

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06974000130033 UDI-DI Date26 Aug 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK211850 Date3 Mar 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K211850 decided 3 Mar 2022 Active
  • FDA GUDID UDI-DI 06974000130033 listed 26 Aug 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K211850
  2. Listed FDA GUDID 06974000130033

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Healthpal
Generic name
Wearable electric massager
Model / reference
FE-7108
Primary DI / UDI-DI
06974000130033
510(k) Number
FDA product code
IRP
GMDN term
Wearable electric massager
Device class
Class II
Regulation number
890.5650
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K211850)

Similar devices

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

Other devices from Xiamen Healthpal Electronic Co., Ltd

Properties

  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)