Skip to content

BodyMed CUS618

by Boxout, LLC

BodyMed CUS618 is a Class II device made by Boxout, LLC, cleared under FDA 510(k) K092546 on 18 Dec 2009 and listed in FDA GUDID since 5 Sep 2016 (UDI-DI 00815802015547), 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) K092546

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 Number00815802015547 UDI-DI Date5 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK092546 Date18 Dec 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K092546 decided 18 Dec 2009 Active
  • FDA GUDID UDI-DI 00815802015547 listed 5 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K092546
  2. Listed FDA GUDID 00815802015547

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
BodyMed
Generic name
Transcutaneous electrical stimulation electrode, single-use
Model / Ref / Catalog
CUS618
Primary DI / UDI-DI
00815802015547
510(k) Number
FDA product code
GXY
GMDN term
Transcutaneous electrical stimulation electrode, single-use
Device class
Class II
Regulation number
882.1320
GUDID distribution status
In Commercial Distribution

Related devices

Category: Transcutaneous electrical stimulation electrode, single-use

Cleared under the same submission (K092546)

and 8 more cleared under K092546

Similar devices

Other devices filed under FDA product code GXY (Electrode, Cutaneous).

Other devices from Boxout, LLC

See all devices from Boxout, LLC →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)