# ISA: Massager, Therapeutic, Electric

- Device class: 1; regulation: 21 CFR 890.5660; FDA's rule: 510(k) exempt
- FDA decisions: 100
- 510(k) review time 2021–2025: median 136 days (middle half 103–336)
- Recalls: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2000: 1
- 2001: 1
- 2004: 1
- 2006: 1
- 2018: 2
- 2021: 1
- 2022: 2
- 2023: 2
- 2024: 1
- 2025: 1

## Most-cited predicates
- K990445: LPG Therapeutic Massager, Models -Esi, Therapeutic Massager/Vibrator (2000), cited by 7
- K030876: Cynosure Triactive Therapeutic Massage System (2004), cited by 5
- K173692: D-Actor 200 Vibration Massage System (2018), cited by 5
- K210451: OrthoGold 100 (2021), cited by 2
- K912383: Vibratouch II Cordless Wand Massager (1991), cited by 1
- K850851: G5 Apparatus T, K1, K3 & the President Model's (1985), cited by 1
- K935459: Omron Massager Model HM-45 (1994), cited by 1
- K220538: DolorClast Radial (2022), cited by 1
- K053225: Cellu M6 Keymodule I (2006), cited by 1

Source page: https://510kreport.com/product-code/ISA
Data by year (CSV): https://510kreport.com/product-code/ISA.csv