MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS— 510(k) K905207

Name: FDA 510(k) clearance K905207
Creator: U.S. Food and Drug Administration
Published: 1991-01-22

Substantially Equivalent for Some Indications

Micro Surgical Instruments Corp.

FDA 510(k) clearance K905207 for MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS, Substantially Equivalent for Some Indications on 1991-01-22. Applicant: Micro Surgical Instruments Corp.. Device class: 1.

Clearance details

Applicant: Micro Surgical Instruments Corp.
Product code: Code IME
Device class: Class 1
Regulation: 21 CFR 890.5700
Advisory panel: Physical Medicine
Date received: 1990-11-20
Decision date: 1991-01-22
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Valencia, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IME

view all

K923627 — COLD PACK1993-04-14
K915876 — HOTPAD1993-02-12
K921446 — HOT OR COLD PACK (THERMIPAQ)1992-07-13
K882413 — SUBOCCIPITAL ICE PILLOW1988-11-30
K863654 — RE-HEATER, HOT PACK1986-10-23

More clearances from Micro Surgical Instruments Corp.

view all

K931395 — SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEM1994-01-28
K932492 — IMPLANTOLOGY MODULE, MODEL 21751993-10-05
K930205 — ELECTRIC WIRE DRIVER, MODEL 2640E1993-08-02
K914998 — MICROAIRE(R) FACIAL BONE PLATING SYSTEM1992-06-02
K915139 — MODEL 2250-000 ZIMMER STYLE SAGITTAL SAW MODULE1992-02-05

Adverse events under product code IME

product code IME

Other: 1
Total: 1

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.