| Device Classification Name |
Massager, Therapeutic, Electric
|
| 510(k) Number |
K890643 |
| Device Name |
VITALON CHAIR MASSAGER MODEL V-CHR2 |
| Applicant |
| Nexus Co. , Ltd. C/O Yama Trans Co. , Ltd. |
| 1-2-1-309 Ebisu-Nishi |
| Shibuya-Ku, Tokyo |
|
Japan 150,
ID
|
|
| Applicant Contact |
EIICHI YAMAMOTO |
| Correspondent |
| Nexus Co. , Ltd. C/O Yama Trans Co. , Ltd. |
| 1-2-1-309 Ebisu-Nishi |
| Shibuya-Ku, Tokyo |
|
Japan 150,
ID
|
|
| Correspondent Contact |
EIICHI YAMAMOTO |
| Regulation Number | 890.5660 |
| Classification Product Code |
|
| Date Received | 02/08/1989 |
| Decision Date | 02/22/1989 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Physical Medicine
|
| 510k Review Panel |
Physical Medicine
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|