The following data is part of a premarket notification filed by C.a.i. Industries Corp. with the FDA for Ws Frequency Spectrum Effect Physiatrics Apparatus.
| Device ID | K954577 |
| 510k Number | K954577 |
| Device Name: | WS FREQUENCY SPECTRUM EFFECT PHYSIATRICS APPARATUS |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | C.A.I. INDUSTRIES CORP. 307 W. MAIN ST., SUITE 10 Alhambra, CA 91801 |
| Contact | Lu Rao |
| Correspondent | Lu Rao C.A.I. INDUSTRIES CORP. 307 W. MAIN ST., SUITE 10 Alhambra, CA 91801 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-02 |
| Decision Date | 1997-05-09 |