Seca 333
EMR validated baby scale with WLAN function.
25manufacturers in China registered for this device type
3catalogue numbers in this listing
3510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Guangdong (9), Jiangsu (8), Zhejiang (7). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Chartek Electronic (Yang Zhou) Ltd | Yangzhou City, Jiansu | Jiangsu | Contract manufacturer | 6 |
| Nanjing Easthigh Measurement Co Ltd | Nanjing | Jiangsu | Contract manufacturer | 5 |
| A&D Electronics (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 4 |
| Dongguan Beaver Plastic & Metal Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Krell Precision (Yangzhou) Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 4 |
| Wuxi Weigher Factory Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 4 |
| seca Medical Measuring Systems (pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 4 |
| Transcell Electronics Scale Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 3 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
Showing 12 of 25. All 25 manufacturers in China registered for Scale, Patient
Record
| Listed by | Seca, Germany |
|---|---|
| FDA product code | FRW |
| Device type | Scale, Patient |
| Device class | Class 1 |
| Regulation | 21 CFR 880.2720 |
| Establishment | Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-07-29 |
| Record revised | 2020-02-21 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Distribution end date | 2025-03-11 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 333 | In distribution | |
| 333 | In distribution | |
| 333 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Health o meter Professional | Pelstar LLC | 58 |
| Detecto | Cardinal Scale Manufacturing Company | 48 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 37 |
| Charder | Charder Electronic Co., Ltd. | 34 |
| Clinton Industries | Clinton Industries, Inc | 21 |
| SR Scales | S R Instruments, Inc. | 19 |
| Healthweigh | Rice Lake Weighing Systems | 11 |
| Myboxshop | Myboxshop, Inc. | 6 |
| Tanita Digital Baby Scale | Tanita International Ltd. | 6 |
| Direct Supply | Cardinal Scale Manufacturing Company | 5 |
| Doran Scales | Doran Scales, Inc. | 4 |
| Midmark | Midmark Corporation | 4 |
Showing 12 of 82. All products under Scale, Patient
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K822135 | 1982-07-30 |
| K822043 | 1982-07-28 |
| K822042 | 1982-07-28 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2019-06-19 | Class II | Process design | It has been determined that the wheels on the baby scale cart can unexpectedly loosen and in the worst case, detach from the cart completely. If this occurs the cart can become unstable and tip over, potentially leading to the scale falling | 254 scale carts |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.