510(k) clearances

EMS (FlexPulse, MagnaCore, Magnetika)

Cpmt Laser (Canadian Pioneer Medical Technology Corporation) · Physical Medicine

K241601Substantially EquivalentTraditionalNGX
Open FDA's page for this record
Third party flag
N
City
Toronto
Advisory committee description
Physical Medicine
Address 1
460 Garyray Dr., N. York
Statement or summary
Summary
Product code
NGX
Zip code
M9L1P8
Applicant
Cpmt Laser (Canadian Pioneer Medical Technology Corporation)
Decision date
2025-02-25
Decision code
SESE
Country code
CA
Device name
EMS (FlexPulse, MagnaCore, Magnetika)
Advisory committee
PM
Contact
Rashid Reza Mir Sayah
K number
K241601
Date received
2024-06-04
Review advisory committee
PM
Postal code
M9L1P8
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Stimulator, Muscle, Powered, For Muscle Conditioning
Medical specialty description
Physical Medicine
Regulation number
890.5850
Device class
2
Registration number
3015007456, 3015214304, 3033844600, 3010880718, 3004081884, 3026322014, 3010097863, 3016832824, 3009102830, 3023613474, 3005170249, 3008345424, 3012840029, 3008806536, 3025367760, 3012651177, 3030412027, 1061158, 3013423303, 3015452693, 3017887847, 3038295706, 3007615436, 3012729332, 3006850006, 3004183512, 3015282440, 3010078417, 3025235024, 3014647250, 1054713, 3026400760, 3035374386, 9611558, 3012134907, 3009437400, 3015529344, 3010385841, 3010427504, 3007120647 +171 more
FEI number
3015007456, 3015214304, 3033844600, 3010880718, 3004081884, 3026322014, 3010097863, 3016832824, 3006076154, 3009102830, 3023613474, 3005170249, 3008345424, 3002808188, 3012840029, 3008806536, 3025367760, 3012651177, 3030412027, 3013423303, 3015452693, 3017887847, 3038295706, 3007615436, 3012729332, 3006850006, 3004183512, 3015282440, 3010078417, 3025235024, 3014647250, 3026400760, 3035374386, 3012134907, 3009437400, 3015529344, 3010385841, 3010427504, 3007120647, 3018940143 +171 more
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Join as a DoctorSell on MedGrid

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.