The following data is part of a premarket notification filed by Meditech International, Inc. with the FDA for Bioflex Professional Therapy System.
| Device ID | K023621 |
| 510k Number | K023621 |
| Device Name: | BIOFLEX PROFESSIONAL THERAPY SYSTEM |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | MEDITECH INTERNATIONAL, INC. 1151 HOPE ST. Stamford, CT 06907 |
| Contact | Richard Keen |
| Correspondent | Richard Keen MEDITECH INTERNATIONAL, INC. 1151 HOPE ST. Stamford, CT 06907 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-29 |
| Decision Date | 2003-04-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B271MCU0 | K023621 | 000 |
| B271DUO2400 | K023621 | 000 |
| B271DUO1800 | K023621 | 000 |
| B271LSB3000P0 | K023621 | 000 |
| B271LSB2250P0 | K023621 | 000 |