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Insight Discovery Algometer 900-015-2

by SRS Medical Systems, Inc.

Insight Discovery Algometer 900-015-2 is a Class II device made by SRS Medical Systems, Inc., cleared under FDA 510(k) K063447 on 16 Aug 2007 and listed in FDA GUDID since 20 Aug 2021 (UDI-DI 00890477000159), 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) K063447

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 Number00890477000159 UDI-DI Date20 Aug 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK063447 Date16 Aug 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K063447 decided 16 Aug 2007 Active
  • FDA GUDID UDI-DI 00890477000159 listed 20 Aug 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K063447
  2. Listed FDA GUDID 00890477000159

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Insight Discovery Algometer
Generic name
Biofeedback system application software
Model / reference
900-015-2
Primary DI / UDI-DI
00890477000159
510(k) Number
FDA product code
HCC, IKN
GMDN term
Biofeedback system application software
Device class
Class II
Regulation number
882.5050, 890.1375
GUDID distribution status
In Commercial Distribution

Related devices

Category: ElectromyographBiofeedback system application software

Cleared under the same submission (K063447)

and 4 more cleared under K063447

Similar devices

Other devices filed under FDA product code HCC (Device, Biofeedback).

Other devices from SRS Medical Systems, Inc.

See all devices from SRS Medical Systems, Inc. →

Properties

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