Bionic Products Pty., Ltd. · 89-08 · AUSTRALIA
For Bionic Products Pty., Ltd., import alert is 89-08; country is AUSTRALIA; 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)"; 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 2026-09-30.
- 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
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and FDA notes
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html