The TBL-ABI is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD). TBL-ABI is intended for the rapid measurement of ankle-brachial…
The TBL-ABI is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD). TBL-ABI is intended for the rapid measurement of ankle-brachial pressure index (ABPI), or ankle-brachial index (ABI), and pulse volume recording (PVR) / volume plethysmography in adults. It is suitable for use in wound care assessment, for assessing symptomatic PAD, and as a screening device for PAD. It may also be used on patients with venous or arterial ulcers prior to the application of compression therapy. TBL-ABI can be used on patients with unilateral lower limb amputation.
Who Else Makes It
All of them in Guangdong.
Record
Regulatory record for TBL-ABI | Listed by | LD Technology LLC, United States |
| FDA product code | JOM |
| Device type | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2780 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K173696 |
| Record published | 2019-01-16 |
| Record revised | 2019-11-08 (version 2) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Label carries | lot or batch number, manufacturing date, serial number |
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.