National Biological Corp.
Twinsburg, OH, US
National Biological Corp. appears in FDA device records in Twinsburg, OH. FDA records list 28 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 4 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 28 510(k) clearances for National Biological Corp. between 1977 and 2015. The busiest year on record is 1987, with 8. The most recent is 2015, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 4 |
| 1981 | 1 |
| 1982 | 1 |
| 1987 | 8 |
| 1988 | 1 |
| 1989 | 3 |
| 1990 | 3 |
| 1992 | 1 |
| 1993 | 2 |
| 1998 | 1 |
| 2004 | 1 |
| 2007 | 1 |
| 2015 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K150912 | Houva-NET Control System | FTC | Substantially Equivalent | |
| K070934 | PANOSOL II TRU-BLU, MODEL UBL-417 | FTC | Substantially Equivalent | |
| K041212 | HOUVA 3 PHOTOTHERAPY SYSTEM | FTC | Substantially Equivalent | |
| K982082 | HANDISOL WOUND HEALING | FTC | Substantially Equivalent | |
| K934808 | UVISOL AND UVISOL II | FTC | Substantially Equivalent | |
| K924969 | PHOTOTHERAPY TIMER | FTC | Substantially Equivalent | |
| K924077 | HANDISOL | FTC | Substantially Equivalent | |
| K904428 | PANOSOL II UAB-228 | FTC | Substantially Equivalent | |
| K904427 | PANOSOL II UVB-206 | FTC | Substantially Equivalent | |
| K904426 | PANOSOL II UVA-218 | FTC | Substantially Equivalent | |
| K885029 | HOUVA II UVA/UVB | FTC | Substantially Equivalent | |
| K885026 | HOUVA II UVB | FTC | Substantially Equivalent | |
| K885025 | HOUVA II UVA | FTC | Substantially Equivalent | |
| K882722 | HOUVA-BED | FTC | Substantially Equivalent | |
| K872707 | PANOSOL 2000 624-404 | FTC | Substantially Equivalent | |
| K872706 | PANOSOL 2000 624-616 | FTC | Substantially Equivalent | |
| K872651 | PANOSOL 2000 624-414 | FTC | Substantially Equivalent | |
| K872650 | PANOSOL 2000 624-604 | FTC | Substantially Equivalent | |
| K872649 | HAND/FOOT UVA/UVB 624-224 | FTC | Substantially Equivalent | |
| K872605 | HAND/FOOT UVA 624-218 | FTC | Substantially Equivalent | |
| K872604 | HAND/FOOT 624-208 | FTC | Substantially Equivalent | |
| K864546 | MAXI-TAN DEVICE | FTC | Substantially Equivalent | |
| K827890 | FOLDALITE UNIT | FTC | Substantially Equivalent | |
| K810668 | HO-B-LITE VI UNIT | KGL | Substantially Equivalent | |
| K761189 | HOUVA-LITE SOLE UNIT #502 | FTC | Substantially Equivalent | |
| K761188 | HOUVA-LITE PALM UNIT #501 | FTC | Substantially Equivalent | |
| K761187 | HOUVA-LITE LEG UNIT #701 | FTC | Substantially Equivalent | |
| K761186 | HOUVA-LITE ARM UNIT #601 | FTC | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1683-2017 | Hand Foot II, UVB-138. One device per box; device is surrounded by foam inserts inside a corrugated box. For UV phototherapy treatment. | The wiring may allow the lamps to turn on with the key switch rather than the timer. | Class II | Terminated | |
| Z-1778-2013 | Dermalight 80 Model Number UVB-080, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and Vitiligo. | The incorrect manual may have been packaged with this product. UVB-080 devices may have included the manual for a UVA-083 device. | Class III | Terminated | |
| Z-1779-2013 | Dermalight 80 Model Number UVB-083, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and Vitiligo. | The incorrect manual may have been packaged with this product. UVB-083 devices may have included the manual for a UVA-080 device. | Class III | Terminated | |
| Z-1309-2008 | HOUVA III Phototherapy System with DermaSense Technology comes on one skid within 10 cardboard boxes. A therapeutic product designed for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders. | Software allows operator to override "low line voltage" error warning and store light intensity value. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain