ECOLOTION TRANSMISSION AND MASSAGE LOTION— 510(k) K962840
Substantially EquivalentEco-Med Pharmaceuticals, Inc.
FDA 510(k) clearance K962840 for ECOLOTION TRANSMISSION AND MASSAGE LOTION, Substantially Equivalent on 1996-12-23. Applicant: Eco-Med Pharmaceuticals, Inc.. Device class: 2.
Clearance details
- Applicant
- Eco-Med Pharmaceuticals, Inc.
- Product code
- Code ITX
- Device class
- Class 2
- Regulation
- 21 CFR 892.1570
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mississauga, Ontario, CA
Recent devices under product code ITX
view allMore clearances from Eco-Med Pharmaceuticals, Inc.
view allAdverse events under product code ITX
product code ITX- Death
- 6
- Injury
- 137
- Malfunction
- 2,036
- Total
- 2,179
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K962840
K-number listed on FDA's recall record- Z-0010-2022 — Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:
- Z-2583-2021 — EcoLotion Transmission Lotion, used in ultrasound procedures. Item/Description: NC70481/Eco Lotion 5 liters, NC70482/Eco Lotion with Aloe 5 liters, NC70482C/Eco Lotion with Aloe 5 liters (4); Myossage Lotion, 1 Gallon, Item: NC31208
- Z-0225-2022 — Scrip Creme All Purpose Lotion Intended for use in acoustic coupling of ultrasound transducer to tissue
- Z-2480-2021 — EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and EcoLotion Transmission Lotion 1) 100, 200 gel Intended for use in acoustic coupling of ultrasound transducer to tissue 2) Lotion Ecolotion transmission and massage lotion is intended to be used as an accessory to ultrasonic transducers and ultrasound monitors. Ecolotion is intended to be used externally only as a coupling medium for use in ultrasound procedures.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K962840.
Data sourced from openFDA. This site is unofficial and independent of the FDA.