Manamed, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Manamed, Inc.” (first 2016, latest 2026), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 156 days. Since 2017 the median was 166 days, against 137 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 56 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 2 | 175 |
| 2021 | 1 | 30 |
| 2022 | 1 | 448 |
| 2023 | 2 | 194 |
| 2024 | 0 | — |
| 2025 | 1 | 131 |
| 2026 | 1 | 142 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Manamed, Inc. took a median 166 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 137 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JOW | Sleeve, Limb, Compressible | 4 | 4 |
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | 2 | 2 |
| IRP | Massager, Powered Inflatable Tube | 2 | 2 |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 1 | 1 |
Review panels
- Cardiovascular (4)
- Physical Medicine (4)
- Neurology (1)
Most recent Manamed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260944 | ManaCold Compression System | IRP | 2026-08-12 | 142 |
| K251446 | PlasmaFlow X Compression Sleeve Device (XPF0001) | JOW | 2025-09-17 | 131 |
| K231569 | ManaFlexx 2 (model: MF002-RX, MF002-OTC) | NUH | 2023-11-03 | 156 |
| K222098 | ManaSport+ | IMI | 2023-03-08 | 233 |
| K210284 | ManaSport | IMI | 2022-04-26 | 448 |
| K211253 | PlasmaWave | JOW | 2021-05-26 | 30 |
| K200353 | ManaFlow | JOW | 2020-08-06 | 175 |
| K200351 | PlasmaFlight | IRP | 2020-08-05 | 175 |
| K160318 | PlasmaFlow | JOW | 2016-04-01 | 56 |
Recalls
openFDA lists no recalls under a recalling firm named Manamed, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Manamed, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Manamed, Inc.” (first 2016, latest 2026), across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Manamed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Manamed, Inc. is 156 days. Since 2017: 166 days, versus 137 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Manamed, Inc.?
The most frequent FDA product codes under this applicant name are JOW (Sleeve, Limb, Compressible, 4); IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat, 2); IRP (Massager, Powered Inflatable Tube, 2).
Next steps
- See all 9 Manamed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JOW, Manamed, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.