Body Clock Health Care, Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Body Clock Health Care, Ltd.” (first 2002, latest 2009), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 91 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 |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 6 | 6 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
Review panels
- Neurology (6)
- Physical Medicine (1)
Most recent Body Clock Health Care, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K091045 | SMART TENS, MODEL: D-BC05T | GZJ | 2009-12-18 | 249 |
| K041359 | BODY CLOCK STIMPLUS AND STIMPLUS PRO | GZJ | 2004-08-20 | 91 |
| K022849 | BODY CLOCK TENS N' TONE | GZJ | 2003-05-20 | 266 |
| K021846 | 804SIII; 804W; LIBRA TENS; 410; S-TENS II | GZJ | 2002-11-22 | 170 |
| K022731 | V TENS PLUS | GZJ | 2002-11-14 | 90 |
| K022493 | EMS 400 | IPF | 2002-10-11 | 74 |
| K022076 | FIRST CHOICE & FIRST CHOICE PLUS | GZJ | 2002-09-24 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Body Clock Health Care, Ltd..
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 Therapeutics, Inc. (5 510(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 Clock Health Care, Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Body Clock Health Care, Ltd.” (first 2002, latest 2009), across 2 product codes in 2 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 Clock Health Care, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Body Clock Health Care, Ltd. is 91 days.
Which FDA product codes appear under Body Clock Health Care, Ltd.?
The most frequent FDA product codes under this applicant name are GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 6); IPF (Stimulator, Muscle, Powered, 1).
Next steps
- See all 7 Body Clock Health Care, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GZJ, Body Clock Health Care, Ltd.'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.