Skip to content

DynaVision Belts PB-294

by Precision Biometrics Inc

DynaVision Belts PB-294 is a Class II device made by Precision Biometrics Inc, cleared under FDA 510(k) K123399 on 1 Aug 2013 and listed in FDA GUDID since 19 Dec 2016 (UDI-DI 00853818007262), 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) K123399

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 Number00853818007262 UDI-DI Date19 Dec 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK123399 Date1 Aug 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K123399 decided 1 Aug 2013 Active
  • FDA GUDID UDI-DI 00853818007262 listed 19 Dec 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K123399
  2. Listed FDA GUDID 00853818007262

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
DynaVision Belts
Generic name
Personal device holder, reusable
Model / reference
PB-294
Primary DI / UDI-DI
00853818007262
510(k) Number
FDA product code
IKN, HCC, HCS, KQX
GMDN term
Personal device holder, reusable
Device class
Class II
Regulation number
890.1375, 882.5050, 882.1570, 888.1500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Personal device holder, reusable

Cleared under the same submission (K123399)

and 8 more cleared under K123399

Other devices from Precision Biometrics Inc

See all devices from Precision Biometrics Inc →

Properties

  • Single use
  • Prescription use
Other properties (13, all answered No)