The following data is part of a premarket notification filed by Pro Medical Supplies, Inc. with the FDA for Infrared Heating Device.
| Device ID | K140865 |
| 510k Number | K140865 |
| Device Name: | INFRARED HEATING DEVICE |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | PRO MEDICAL SUPPLIES, INC. ROOM 1706, NO. 128 SONGLE RD. SONGJIANG AREA Shanghai, CN 201600 |
| Contact | Doris Dong |
| Correspondent | Doris Dong PRO MEDICAL SUPPLIES, INC. ROOM 1706, NO. 128 SONGLE RD. SONGJIANG AREA Shanghai, CN 201600 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-03 |
| Decision Date | 2014-09-03 |
| Summary: | summary |