Ultium
Ultium Linear Force SmartLead (500lbf)
6manufacturers in China registered for this device type
23catalogue numbers in this listing
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 | Noraxon U.S.A., Inc. |
|---|---|
| FDA product code | HCC |
| Device type | Device, Biofeedback |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5050 |
| Premarket notification | Exempt |
| Record published | 2026-03-30 |
| Record revised | 2023-06-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, serial number |
| Storage | Handling environment atmospheric pressure 50 to 106 KiloPascal; Handling environment humidity 10 to 100 % RH; Handling environment temperature -40 to 70 °C |
| Distribution end date | 2022-01-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 808 | In distribution | |
| 852 | In distribution | |
| 826 | In distribution | |
| 842S | In distribution | |
| 880 | In distribution | |
| 820 | In distribution | |
| 842 | In distribution | |
| 881 | In distribution | |
| 842X | In distribution | |
| 810 | In distribution | |
| APP01 | In distribution | |
| 829 | In distribution | |
| 821 | In distribution | |
| 824 | In distribution | |
| 826X | In distribution | |
| 826S | In distribution | |
| 811 | In distribution | |
| 802 | In distribution | |
| 817 | In distribution | |
| 842Y | In distribution | |
| 826L | In distribution | |
| 826M | In distribution | |
| 883 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Pathway | Prometheus Group OF NEW Hampshire Limited, THE | 5 |
Showing 12 of 241. All products under Device, Biofeedback
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.