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BEAR 2 Body Evergreen

by Foreo Inc

BEAR 2 Body Evergreen is a medical device (FDA Class II; FDA product code NFO, Stimulator, Transcutaneous Electrical, Aesthetic Purposes) made by Foreo Inc, cleared under FDA 510(k) K232242 on 13 May 2024 and listed in FDA GUDID since 16 May 2024 (UDI-DI 07350120791863), 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) K232242

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 Number07350120791863 UDI-DI Date16 May 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK232242 Date13 May 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K232242 decided 13 May 2024 Active
  • FDA GUDID UDI-DI 07350120791863 listed 16 May 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K232242
  2. Listed FDA GUDID 07350120791863

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
BEAR 2 Body
Generic name
Physical therapy transcutaneous neuromuscular electrical stimulation system
Model / reference
Evergreen
Primary DI / UDI-DI
07350120791863
510(k) Number
FDA product code
NFO
GMDN term
Physical therapy transcutaneous neuromuscular electrical stimulation system
Device class
Class II
Regulation number
882.5890
GUDID distribution status
In Commercial Distribution

Related devices

Category: Physical therapy transcutaneous neuromuscular electrical stimulation system

Cleared under the same submission (K232242)

Similar devices

Other devices filed under FDA product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes).

Other devices from Foreo Inc

See all devices from Foreo Inc →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)