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Case IV

by WR Medical Electronics Co.

Case IV is a vibratory biothesiometer (FDA Class I; FDA product code LLN, Device, Vibration Threshold Measurement) made by WR Medical Electronics Co., cleared under FDA 510(k) K910624 on 17 Jan 1992 and listed in FDA GUDID since 29 Aug 2016 (UDI-DI 00702173355696), 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) K910624

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 Number00702173355696 UDI-DI Date29 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK910624 Date17 Jan 1992DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K910624 decided 17 Jan 1992 Active
  • FDA GUDID UDI-DI 00702173355696 listed 29 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K910624
  2. Listed FDA GUDID 00702173355696

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Case
Generic name
Vibratory biothesiometer
Model / reference
IV
Primary DI / UDI-DI
00702173355696
510(k) Number
FDA product code
LLN
GMDN term
Vibratory biothesiometer
Device class
Class I
Regulation number
882.1200
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code LLN (Device, Vibration Threshold Measurement).

Other devices from WR Medical Electronics Co.

See all devices from WR Medical Electronics Co. →

Properties

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