ISA
- Product code
- ISA
- Device name
- Massager, Therapeutic, Electric
- Device class
- Class 1
- 21 CFR
- 21 CFR 890.5660
- Medical specialty
- Physical Medicine
- Marketing pathway
- 510(K) Exempt
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 100 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K243488 | 2025-02-06 | Termosalud | VMAT PRO | |
| K240358 | 2024-06-05 | Shenzhen Dongdixin Technology Co., Ltd… | ShockPhysio Mobile (model SW3200 Basic) | — |
Official FDA classification page: ISA
Classification and pathway per current FDA publications. Data from openFDA (CC0).