FDA product code ISA: Massager, Therapeutic, Electric
ISA is the FDA product code for massager, therapeutic, electric. It is a Class I device, regulated under 21 CFR 890.5660 and reviewed by the Physical Medicine panel. FDA has cleared 100 510(k) submissions under ISA, 6 in the last five years, from 74 different applicants. The average 510(k) review took 137 days (median 86); 103 days on average over the last three years. FDA has posted 10 recalls for ISA devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Massager, Therapeutic, Electric |
| Device class | Class I |
| Regulation | 21 CFR 890.5660 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
510(k) clearances per year for ISA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 110 |
| 2021 | 1 | 78 |
| 2022 | 2 | 258 |
| 2023 | 2 | 514 |
| 2024 | 1 | 120 |
| 2025 | 1 | 86 |
Compare with all 510(k) review times · Search every ISA clearance
Top ISA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Conair Corp. | 10 | 1994-12-13 |
| Kinsei Shiatsu, Inc. | 5 | 1995-09-29 |
| General Physiotherapy, Inc. | 5 | 1987-04-06 |
| Wahl Clipper Corp. | 3 | 1994-12-08 |
| Omron Healthcare, Inc. | 3 | 1994-03-04 |
69 more applicants have ISA clearances. See the full list in Caduvo.
Most recent ISA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243488 | Termosalud | VMAT PRO | 2025-02-06 | 86 |
| K240358 | Shenzhen Dongdixin Technology Co., Ltd. | ShockPhysio Mobile (model SW3200 Basic) | 2024-06-05 | 120 |
| K221865 | BTL Industries, Inc. | BTL-094 | 2023-04-14 | 291 |
| K210166 | Medispec, Ltd. | Omnispec ED1000 | 2023-01-27 | 736 |
| K213120 | Tissue Regeneration Technologies, LLC Dba AS Softwave Trt | OW100S (model OW100S-US) | 2022-10-12 | 380 |
Recalls for ISA devices
10 product recalls in 8 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2026-06-23.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2025 | 3 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code ISA?
ISA is the FDA product code for massager, therapeutic, electric. It is a Class I device, regulated under 21 CFR 890.5660 and reviewed by the Physical Medicine panel.
What device class is ISA?
Class I, regulation 21 CFR 890.5660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ISA?
Across 100 cleared submissions the average was 137 days from receipt to decision (median 86).
Which companies have the most ISA clearances?
Conair Corp. (10); Kinsei Shiatsu, Inc. (5); General Physiotherapy, Inc. (5); Wahl Clipper Corp. (3); Omron Healthcare, Inc. (3).
Have ISA devices been recalled?
Yes: 10 product recalls across 8 recall events; the most recent began 2026-06-23.
Next steps
- Run an FDA pathway report with predicate devices for product code ISA
- Run a recall and safety report across every ISA manufacturer
- Watch product code ISA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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