Device Classification Name |
stimulator, muscle, powered
|
510(k) Number |
K000741 |
Device Name |
EMS JUMPER II DUAL CHANNEL NEUROMUSCULAR STIMULATOR SYSTEM, MODEL E-188 |
Applicant |
138 MEDICAL SUPPLIES, INC. |
55 NORTHERN BLVD., SUITE 200 |
GREAT NECK,
NY
11021
|
|
Applicant Contact |
SUSAN D GOLDSTEIN-FALK |
Correspondent |
138 MEDICAL SUPPLIES, INC. |
55 NORTHERN BLVD., SUITE 200 |
GREAT NECK,
NY
11021
|
|
Correspondent Contact |
SUSAN D GOLDSTEIN-FALK |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 03/07/2000 |
Decision Date | 10/24/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|