TEMPRA COLD PACK, REORDER NO. TC150— 510(k) K963220

Name: FDA 510(k) clearance K963220
Creator: U.S. Food and Drug Administration
Published: 1996-10-10

Substantially Equivalent

Tempo Technology, Inc.

FDA 510(k) clearance K963220 for TEMPRA COLD PACK, REORDER NO. TC150, Substantially Equivalent on 1996-10-10. Applicant: Tempo Technology, Inc.. Device class: 1.

Clearance details

Applicant: Tempo Technology, Inc.
Product code: Code IMD
Device class: Class 1
Regulation: 21 CFR 890.5710
Advisory panel: Physical Medicine
Date received: 1996-08-16
Decision date: 1996-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sarasota, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IMD

view all

K221653 — InfaTherm Disposable Infant Warming Mattress2022-10-06
K163295 — Infant Transport Mattress Warmer with Disc2017-07-24
K112547 — NEO NEST2012-03-06
K082087 — EYEFEEL OPHTHALMIC WARMER2008-09-11
K071710 — BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS)2007-08-14

More clearances from Tempo Technology, Inc.

view all

K934700 — MODEL 90P PORTABLE MEDICAL DIAGNOSTIC X-RAY1994-03-16
K896963 — TRIMODE SP DENTAL INTRA ORAL X-RAY1990-01-22

Adverse events under product code IMD

product code IMD

Death: 3
Injury: 600
Total: 603

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.