Bionic Products Pty., Ltd. · 89-08 · AUSTRALIA
For Bionic Products Pty., Ltd. · 89-08 · AUSTRALIA, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is AUSTRALIA; product code is 73 - - - -- Anesthesiology | 74 - - - -- Cardiovascular | 76 - - - -- Dental | 77 - - - -- Ear,Nose And Throat | 78 - - - -- Gastroenterological & Urological | 79 - - - -- General & Plastic Surgery | 80 - - - -- General Hospital/Personal Use | 84 - - - -- Neurological | 85 - - - -- Obstetrical & Gynecological | 86 - - - -- Ophthalmic | 87 - - - -- Orthopedic | 89 - - - -- Physical Medicine | 90 - - - -- Radiology; date published is 12/20/2018; address is 63 Manly Drive , Robina, Queensland AUSTRALIA, verified against its source on 2026-09-16.
- Firm
- Bionic Products Pty., Ltd. verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- AUSTRALIA verified
- Address
- 63 Manly Drive , Robina, Queensland AUSTRALIA verified
- Date published
- 12/20/2018 verified
- Product code
- 73 - - - -- Anesthesiology | 74 - - - -- Cardiovascular | 76 - - - -- Dental | 77 - - - -- Ear,Nose And Throat | 78 - - - -- Gastroenterological & Urological | 79 - - - -- General & Plastic Surgery | 80 - - - -- General Hospital/Personal Use | 84 - - - -- Neurological | 85 - - - -- Obstetrical & Gynecological | 86 - - - -- Ophthalmic | 87 - - - -- Orthopedic | 89 - - - -- Physical Medicine | 90 - - - -- Radiology each item verified
- FDA notes
- Therapeutic Ionisers; Class III; 12/26/2002 | Therapeutic Ionisers; Class III; 12/26/2002 | Therapeutic Ionisers; Class III; 12/26/2002 | Therapeutic Ionisers; Class III; 12/26/2002 | Therapeutic Ionisers; Class III; 12/26/2002 | Therapeutic Ionisers; Class III; 12/26/2002 | Therapeutic Ionisers; Class III; 12/26/2002 | Therapeutic Ionisers; Class III; 12/26/2002 | Therapeutic Ionisers; Class III; 12/26/2002 | Therapeutic Ionisers; Class III; 12/26/2002 | Therapeutic Ionisers; Class III; 12/26/2002 | Therapeutic Ionisers; Class III; 12/26/2002 | Therapeutic Ionisers; Class III; 12/26/2002 each item verified
What the source says
Bionic Products Pty., Ltd. Date Published : 12/20/2018 63 Manly Drive , Robina, Queensland AUSTRALIA 73 - - - -- Anesthesiology Date Published: 12/20/2018 Notes: Therapeutic Ionisers; Class III; 12/26/2002 74 - - - -- Cardiovascular Date Published: 12/20/2018 Notes: Therapeutic Ionisers; Class III; 12/26/2002 76 - - - -- Dental Date Published: 12/20/2018 Notes: Therapeutic Ionisers; Class III; 12/26/2002 77 - - - -- Ear,Nose And Throat Date Published: 12/20/2018 Notes: Therapeutic Ionisers; Class III; 12/26/2002 78 - - - -- Gastroenterological & Urological Date Published: 12/20/2018 Notes: Therapeutic Ionisers; Class III; 12/26/2002 79 - - - -- General & Plastic Surgery Date Published: 12/20/2018 Notes: Therapeutic Ionisers; Class III; 12/26/2002 80 - - - -- General Hospital/Personal Use Date Published: 12/20/2018 Notes: Therapeutic Ionisers; Class III; 12/26/2002 84 - - - -- Neurological Date Published: 12/20/2018 Notes: Therapeutic Ionisers; Class III; 12/26/2002 85 - - - -- Obstetrical & Gynecological Date Published: 12/20/2018 Notes: Therapeutic Ionisers; Class III; 12/26/2002 86 - - - -- Ophthalmic Date Published: 12/20/2018 Notes: Therapeutic Ionisers; Class III; 12/26/2002 87 - - - -- Orthopedic Date Published: 12/20/2018 Notes: Therapeutic Ionisers; Class III; 12/26/2002 89 - - - -- Physical Medicine Date Published: 12/20/2018 Notes: Therapeutic Ionisers; Class III; 12/26/2002 90 - - - -- Radiology Date Published: 12/20/2018 Notes: Therapeutic Ionisers; Class III; 12/26/2002
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html