Fuji Medical Insts. Mfg. Co., Ltd. · 89-08 · JAPAN
For Fuji Medical Insts. Mfg. Co., Ltd. · 89-08 · JAPAN, 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 JAPAN; 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 09/16/2009; address is 5 Chome 5-21 , Nipponbashi; Naniwa , Osaka, Osaka JAPAN, verified against its source on 2026-09-16.
- Firm
- Fuji Medical Insts. Mfg. Co., 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
- JAPAN verified
- Address
- 5 Chome 5-21 , Nipponbashi; Naniwa , Osaka, Osaka JAPAN verified
- Date published
- 09/16/2009 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
- All devices. DE. "New Health Club" Low Frequency Therapeutic Apparatus Type C Model HC-32. 8/13/1993 verified
What the source says
Fuji Medical Insts. Mfg. Co., Ltd. Date Published : 09/16/2009 5 Chome 5-21 , Nipponbashi; Naniwa , Osaka, Osaka JAPAN 73 - - - -- Anesthesiology Date Published: 09/16/2009 Notes: All devices. DE. "New Health Club" Low Frequency Therapeutic Apparatus Type C Model HC-32. 8/13/1993 74 - - - -- Cardiovascular Date Published: 09/16/2009 76 - - - -- Dental Date Published: 09/16/2009 77 - - - -- Ear,Nose And Throat Date Published: 09/16/2009 78 - - - -- Gastroenterological & Urological Date Published: 09/16/2009 79 - - - -- General & Plastic Surgery Date Published: 09/16/2009 80 - - - -- General Hospital/Personal Use Date Published: 09/16/2009 84 - - - -- Neurological Date Published: 09/16/2009 85 - - - -- Obstetrical & Gynecological Date Published: 09/16/2009 86 - - - -- Ophthalmic Date Published: 09/16/2009 87 - - - -- Orthopedic Date Published: 09/16/2009 89 - - - -- Physical Medicine Date Published: 09/16/2009 90 - - - -- Radiology Date Published: 09/16/2009
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html