Body Therapeutics, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Body Therapeutics, Inc.” (first 1980, latest 1983), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 28 days. 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IQK | Orthosis, Cervical | 3 | 3 |
| CCX | Support, Patient Position | 1 | 1 |
| QSB | Orthosis, Truncal, Pregnancy | 1 | 1 |
Review panels
Most recent Body Therapeutics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K831582 | VARI-SUPPORT NECK POSTURE PILLOW | IQK | 1983-06-15 | 29 |
| K821836 | PREGNANCY (W) EDGE | QSB | 1982-07-30 | 38 |
| K821838 | VARI-SUPPORT LOW BACK POSTURE PILLOW | CCX | 1982-07-20 | 28 |
| K821837 | VARI-SUPPORT NECK POSTURE PILLOW | IQK | 1982-07-20 | 28 |
| K802442 | LOW BACK POSTURE PILLOW | IQK | 1980-10-31 | 24 |
Recalls
openFDA lists no recalls under a recalling firm named Body Therapeutics, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Body Clock Health Care, Ltd. (7 510(k)s)
- Body Composition Analog, Inc. (2 510(k)s)
- Body Bike, Inc. (1 510(k)s)
- Body Trim Industrial Co., Ltd. (1 510(k)s)
- Body Watch, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Body Therapeutics, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Body Therapeutics, Inc.” (first 1980, latest 1983), across 3 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 Body Therapeutics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Body Therapeutics, Inc. is 28 days.
Which FDA product codes appear under Body Therapeutics, Inc.?
The most frequent FDA product codes under this applicant name are IQK (Orthosis, Cervical, 3); CCX (Support, Patient Position, 1); QSB (Orthosis, Truncal, Pregnancy, 1).
Next steps
- See all 5 Body Therapeutics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IQK, Body Therapeutics, 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.