| Device Classification Name |
Lamp, Infrared, Therapeutic Heating
|
|---|
| 510(k) Number |
K964397 |
|---|
| Device Name |
THERAPIK |
|---|
| Applicant |
| The Jenex Corporation |
| 50 Brewster St. |
|
Pawtucket,
RI
02860
|
|
| Applicant Contact |
PAMELA PAPINEAU |
| Correspondent |
| The Jenex Corporation |
| 50 Brewster St. |
|
Pawtucket,
RI
02860
|
|
| Correspondent Contact |
PAMELA PAPINEAU |
| Regulation Number | 890.5500 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 11/04/1996 |
|---|
| Decision Date | 11/04/1997 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Physical Medicine
|
|---|
| 510k Review Panel |
Physical Medicine
|
|---|
| Summary |
Summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|