Device Classification Name |
Stimulator, Muscle, Powered, For Muscle Conditioning
|
510(k) Number |
K201131 |
Device Name |
firefly T-2 |
Applicant |
Firstkind Limited |
Hawk House, Peregrine Business Park |
High Wycombe,
GB
HP13 7DL
|
|
Applicant Contact |
Neil Buckley |
Correspondent |
Heyer Regulatory Solutions LLC |
125 Cherry Lane |
Amherst,
MA
01002
|
|
Correspondent Contact |
Sheila Hemeon-Heyer |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 04/28/2020 |
Decision Date | 05/28/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|