BioGraph Infiniti Advanced Reporting
Catalogue number SA7900AR, listed by Thought Technology Ltd., Canada, under Device, Biofeedback. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
1catalogue number
14510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (5), Hebei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Dongdixin Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Shenzhen Konmed Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Shenzhen XFT Medical Limited | Shenzhen | Guangdong | Manufacturer | 8 |
| ISA Mould Engineering Limted | Dongguan | Guangdong | Contract manufacturer | 4 |
| Qinhuangdao Huisianpu Medical Systems Inc. | Qinhuangdao | Hebei | Manufacturer | 4 |
| Shuhai Jingwei(Shenzhen) Information Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
Record
| Listed by | Thought Technology Ltd., Canada |
|---|---|
| FDA product code | HCC |
| Device type | Device, Biofeedback |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5050 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K972723 |
| Record published | 2024-12-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SA7900AR | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ultium | Noraxon U.S.A., Inc. | 23 |
| FlexiCAP | Deymed Diagnostic S.R.O. | 16 |
| Ondamed | Ondamed Inc. | 15 |
| MyoPro | Myomo, Inc. | 12 |
| TeleMyo | Noraxon U.S.A., Inc. | 12 |
| Recording Cap G1 | Deymed Diagnostic S.R.O. | 8 |
| HAL for Medical Use | Cyberdyne Inc. | 8 |
| Disc Electrode 9mm Sn (Tin) | Deymed Diagnostic S.R.O. | 8 |
| Axon | Exsurgo Limited | 8 |
| Innara Health | Innara Health, Inc. | 7 |
| Kangaroo | Cardinal Health 200, LLC | 7 |
| SX230-1000 EMG Sensor | Biometrics Ltd. | 6 |
Showing 12 of 241. All products under Device, Biofeedback
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K915859 | 1992-09-09 |
| K915858 | 1992-09-09 |
| K913898 | 1992-03-26 |
| K903497 | 1991-02-12 |
| K896409 | 1990-10-09 |
| K894840 | 1989-10-13 |
| K883597 | 1988-11-16 |
| K881416 | 1988-09-26 |
| K850642 | 1985-05-17 |
| K850643 | 1985-05-17 |
| K834519 | 1984-01-30 |
| K823146 | 1982-12-03 |
| K822814 | 1982-10-08 |
| K810332 | 1981-05-18 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.