510(k) K150139
- Device
- Rachel's Remedy
- Applicant
- Rachel's Remedies, LLC
- 510(k) number
- K150139
- Product code
- IMA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-05-22
- Date received
- 2015-01-22
- Regulation
- 890.5730
- Classification name
- Pack, Heat, Moist
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Rachel E. Jackson
- Address
- 542 Parkside Ave. Buffalo NY US 14216 14216
FDA Registration Numbers#
- 1043551
- 3016159364
- 8043894
- 3027057394
- 3034629649
- 3006897996
- 3003152436
- 9613446
- 3003079019
- 3016585381
- 3008412545
- 3009960170
- 3006416350
- 3040274588
- 3013539076
- 3036893546
- 3016452400
- 3012184208
- 9611559
- 2432177
- 3008008970
- 3009538555
- 1039131
- 1060934
- 9616086
- 3017149096
- 3002497459
- 3008381107
- 3013856565
- 3017504598
- 9680104
- 3042148166
- 3012187635
- 3015069920
- 3016796158
- 3016096058
- 3006984486
- 3006537699
- 3015534928
- 2938257
- 3034397207
- 3006169981
- 3010487117
- 3004905643
- 3008970204
- 3012316249
- 8044116
- 3005023997
- 3017264244
- 2183520
- 3007222546
- 3015392301
- 1832415
- 9710567
- 3004727093
- 3030444262
- 3017618922
- 3011191255
- 3009657307
- 3004824601
- 3011118556
- 3013601329
- 8031680
- 3036839106
- 3043654665
- 3002324535
- 3015775984
- 1937310
- 3011182985
- 3008756544
- 3015220641
- 9617045
- 1000467313
- 3009273990
- 3004201320
- 3029952416
- 3007207474
- 3027851849
- 3014675426
- 9615896
Source Documents#
Other 510(k) Records For Product Code IMA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K950701 | WAHL SPORTS RELIEF HOT/COLD MASSAGER ROLLER | Wahl Clipper Corp. | 1995-03-24 |
| K841698 | HEAT PACK | Maddak, Inc. | 1984-05-10 |
| K832803 | STEAM PAK MOIST HEAT | Electro-Med Health Industries, Inc. | 1983-09-20 |
| K823622 | INSULATED THERMOELASTOMER MITT | Fred Sammons, Inc. | 1982-12-30 |
| K803177 | MOIST HEAT PACK | Duro-Med Ind., Inc. | 1980-12-31 |
| K791653 | REUSABLE MOIST HEAT PACK | Tru-Eze Mfg. Co., Inc. | 1979-09-07 |
| K790904 | STAO-HOTPACK | Staodynamics, Inc. | 1979-05-18 |
Legacy Summary#
summary
FDA Review#
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