Device Classification Name |
wheelchair, mechanical
|
510(k) Number |
K992310 |
Device Name |
TONICROSS TRICYCLES, MODELS, T0, T1,T2,T3 AND T4. |
Applicant |
RUPIANI MEDICAL |
98 RUE ALEXANDRE DUMAS |
VAULX EN VELIN,
FR
69120
|
|
Applicant Contact |
JEAN-MARIE MANGENOT |
Correspondent |
RUPIANI MEDICAL |
98 RUE ALEXANDRE DUMAS |
VAULX EN VELIN,
FR
69120
|
|
Correspondent Contact |
JEAN-MARIE MANGENOT |
Regulation Number | 890.3850
|
Classification Product Code |
|
Date Received | 07/09/1999 |
Decision Date | 11/02/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|