The following data is part of a premarket notification filed by National Health-care Equipment, Inc. with the FDA for Infrared Heat Lamps & Massager Model Nh-213.
| Device ID | K913973 |
| 510k Number | K913973 |
| Device Name: | INFRARED HEAT LAMPS & MASSAGER MODEL NH-213 |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | NATIONAL HEALTH-CARE EQUIPMENT, INC. 144 EAST KINGSBRIDGE RD. Mount Vernon, NY 11050 |
| Contact | Peter Winocur |
| Correspondent | Peter Winocur NATIONAL HEALTH-CARE EQUIPMENT, INC. 144 EAST KINGSBRIDGE RD. Mount Vernon, NY 11050 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-06 |
| Decision Date | 1991-11-29 |